A Phase 2 interventional study of Glucagon RTU Injection With Insulin Pump Reduction and Vehicle for Glucagon RTU Injection With Insulin Pump Reduction in Hypoglycemia, sponsored by Xeris Pharmaceuticals. Completed at 1 site in Canada. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Xeris Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 10 studies in Hypoglycemia by Xeris Pharmaceuticals — none open to participants now, none under way, none of them phase 3. Hypoglycemia · Xeris Pharmaceuticals.
Among the 10 studies in Hypoglycemia by Xeris Pharmaceuticals, this one is the 4th largest by enrollment, is the only one that started in 2019, is one of 7 in phase 2, and was the 10th registered.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 48 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →None of the 10 studies in Hypoglycemia by Xeris Pharmaceuticals is open now.
Of the 59 Hypoglycemia studies recruiting now, 23 (39%) set no upper age limit and 31 (53%) stop at 75 or younger; 18 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2019.
Median enrollment 25 across the 10 interventional studies. Of the 10 that completed or were terminated, 10 (100%) have results posted.
Xeris Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Hypoglycemia by Xeris Pharmaceuticals, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study is a randomized, placebo-controlled, double-blind, 2-treatment, 2-period, crossover comparison in a clinical research center (CRC) setting, followed by a randomized, placebo-controlled, double-blinded, 2-arm parallel comparison with a third open-label arm in an outpatient setting. The purpose of the study is to evaluate the preliminary efficacy and safety of Glucagon Ready-to-Use [RTU] to prevent exercise-induced hypoglycemia (EIH) in adults with Type 1 diabetes mellitus (T1D), who perform regular, moderate-to-high intensity aerobic exercise.
There were 2 phases of this study: CRC and Outpatient. The initial posting of this study reflected the 3 treatment arms included in the Outpatient Phase of the study, without including the CRC and Outpatient Phases separately.
CRC Phase:
The CRC Phase was comprised of 2 visits that included daytime exercise sessions at the CRC or a comparable setting. Subjects were randomized to receive their first treatment at Visit 3 and crossed over (2 to 28 day washout) to their second treatment at Visit 4. The treatments were a single treatment with 30 microliters of either Glucagon RTU (0.15 mg) or placebo with a 50% insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, at the start of exercise, and then 15, 30, 45, 60, and 75 minutes from the start of exercise.
Outpatient Phase:
After completion of the CRC Phase, subjects entered the 12-week Outpatient Phase. Subjects were to maintain a weekly exercise average of 2 to 3 sessions of at least 30 minutes duration. Subjects were assigned randomly in 1:1:1 ratio to administer 30 microliters of one of the following prior to the exercise sessions: Glucagon RTU (0.15 mg) with a 50% insulin pump reduction, placebo with a 50% pump reduction or Glucagon RTU (0.15 mg) without an insulin pump reduction. Blood glucose was assessed 15 minutes prior to the start of exercise, just before exercise, after 30 minutes of exercise, at the end of exercise (if longer than 30 minutes), and 30 minutes post-exercise.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CRC Phase: 2-arm randomized double-blind crossover, Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump
Drug: Glucagon RTU Injection With Insulin Pump Reduction
CRC Phase: 2-arm randomized double-blind crossover, Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump
Other: Vehicle for Glucagon RTU Injection With Insulin Pump Reduction
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection with 50% reduction in the insulin pump (double-blind arm)
Drug: Glucagon RTU Injection With Insulin Pump Reduction
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Vehicle for Glucagon RTU Injection 30 microliters vehicle with 50% reduction in the insulin pump (double-blind arm)
Other: Vehicle for Glucagon RTU Injection With Insulin Pump Reduction
Outpatient Phase: 3-arm randomized comparison (2-arm double-blind, 1-arm open-label), Glucagon RTU Injection 30 microliters of 0.15 mg injection without a reduction in the insulin pump (open-label arm)
Drug: Glugaon RTU Injection Without Insulin Pump Reduction
0.15 mg injection with 50% pump reduction
Also known as: XP-3994
vehicle injection with 50% pump reduction
Also known as: Placebo
0.15 mg injection without pump reduction
Also known as: XP-3994
Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise.
Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if \>1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
Time frame: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously during and within the 30 (+2) minute period following a qualified exercise session.
Outpatient Phase: Mean Number of Hypoglycemic Events
Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
Time frame: Daily; During the 12-week Outpatient Phase qualified exercise sessions were assessed daily and associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.
Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions
Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
Time frame: Daily; During the 12-week Outpatient Phase the occurrence of qualified exercise sessions were assessed daily.
CRC Phase: Interstitial Glucose Below Target Range
Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG \<= 70 mg/dl (\<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG \<54 mg/dL (\<3 mmol/L)
Time frame: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of the exercise session corresponding to each of the treatments during the corresponding in-clinic visit during the CRC Phase.
Outpatient Phase: Interstitial Glucose Levels Below Target Range
Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG \<= 70 mg/dl (\<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG \<54 mg/dL (\<3 mmol/L)
Time frame: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); Assessed continuously 0-300 minutes following the start of each qualified exercise session corresponding to each of the treatments during the Outpatient Phase.
Outpatient Phase: Insulin Use Change From Baseline
Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12
Time frame: Insulin use measured continuously from Study Baseline to End of Study and assessed during Outpatient Phase as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12
Outpatient Phase: Barriers to Physical Activity Diabetes (Type 1): BAPAD-1 Change From Baseline
Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise. The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7.
Time frame: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)
Outpatient Phase: HFS-II Overall Score Change From Baseline
Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II) A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following: Behavior (15 items): things that people with diabetes often do to avoid low blood sugar. Worry (18 items): things that people with diabetes often worry about because of low blood sugar. Lower scores are considered better outcomes, higher scores are considered worse outcomes. The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4.
Time frame: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)
Outpatient Phase: Hypoglycemic Confidence Scale (HCS) Change From Baseline
Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS) The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise. The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4.
Time frame: Baseline to End of Study measured at Outpatient Phase Baseline (Visit 3, Day 1) and Follow-up (Visit 11, 14-21 days after last exercise session, up to Day 134) or Early Termination (at time of discontinuation)
CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise.
Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
Time frame: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.
CRC Phase: Mean Number of Hypoglycemic Events Exercise.
CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level. A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
Time frame: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the associated hypoglycemia events were assessed continuously throughout the 30 (+2) minute period following a qualified exercise session.
CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions
Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.
Time frame: Visit 3 (Day 1) and Visit 4 (Day 3 or any day up to Day 29); At each visit, the number of qualified exercise sessions that occurred.
The study enrolled 48 subjects to participate in the study with a CRC phase followed by an Outpatient phase. The 45 subjects that completed the CRC phase were re-randomized prior to entering the Outpatient phase of the study.
| Milestone | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction |
|---|---|---|---|---|---|---|
| Started | 8 | 10 | 6 | 11 | 5 | 8 |
| Received 1st crc dose | 8 | 10 | 6 | 11 | 5 | 8 |
| Completed | 8 | 10 | 6 | 11 | 5 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction |
|---|---|---|---|---|---|---|
| Started | 8 | 10 | 6 | 11 | 5 | 8 |
| Received 2nd crc dose | 7 | 10 | 6 | 9 | 5 | 8 |
| Completed | 7 | 10 | 6 | 9 | 5 | 8 |
| Not completed | 1 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 |
| Milestone | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Glucagon RTU to Vehicle With 50% Reduction to Outpatient: Glucagon RTU Without Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Vehicle With 50% Reduction | CRC: Vehicle to Glucagon RTU With 50% Reduction to Outpatient: Glucagon RTU Without Reduction |
|---|---|---|---|---|---|---|
| Started | 7 | 10 | 6 | 9 | 5 | 8 |
| Received at least 1 outpatient dose | 7 | 9 | 6 | 9 | 5 | 8 |
| Completed | 7 | 9 | 5 | 9 | 5 | 7 |
| Not completed | 0 | 1 | 1 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 1 |
Mean incidence rate of hypoglycemia during and after sessions of moderate to high intensity aerobic exercise in 12-week Outpatient Phase. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) self-administered study drug no more than 10 min prior to exercise (5 min target), (3) conducted a protocol allowed exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Exercise sessions were to occur at least 2-3 times per week. Only 1 qualified exercise session/subject/day was included in the analysis (the first if \>1). Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
| events/session | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: Overall |
|---|---|---|---|---|
| Outpatient Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise. | 0.12 | 0.39 | 0.16 | 0.24 |
Outpatient Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. A hypoglycemic event was defined as any hypoglycemic event occurring during or within 30 (+2) minutes after completion of a qualified exercise session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
| mean number of events/participant | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: Overall |
|---|---|---|---|---|
| Outpatient Phase: Mean Number of Hypoglycemic Events | 1.94 | 8.43 | 2.86 | 4.3 |
Outpatient Phase: Mean number of qualified exercise sessions, assessed at group level. A qualified exercise session was defined as one were (1) a confirmed blood glucose value of 100-180 mg/dL prior to start of exercise, (2) self-administered the study drug no more than 10 minutes prior to exercise (5 minutes was the target), (3) conducted a protocol allowed exercise for moderate to high intensity for at least 30 minutes and no longer than 75 minutes, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during the session. Exercise sessions were expected to occur at least 2 to 3 times per week. Only 1 qualified exercise session per subject per day was included in the analysis (the first if \>1).
| mean number of sessions/participant | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: Overall |
|---|---|---|---|---|
| Outpatient Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | 15.69 | 21.64 | 17.36 | 18.11 |
Analysis of interstitial glucose (IG) was performed by treatment, independent of the order of treatment during the randomized cross-over CRC Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG \<= 70 mg/dl (\<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG \<54 mg/dL (\<3 mmol/L)
| Participants | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | CRC Phase: Overall |
|---|---|---|---|
| Below range (<=70 mg/dL) | 4 | 5 | 9 |
| Between range (54-70 mg/dL) | 4 | 5 | 9 |
| Below range (<54 mg/dL) | 1 | 1 | 2 |
Analysis of interstitial glucose (IG) was performed by treatment, during the randomized Outpatient Phase. The number of participants are categorized by the following IG levels: Below range, as defined by IG \<= 70 mg/dl (\<=3.89 mmol/L); Between range, as defined by IG between 54 to 70 mg/dL (3 to 3.89 mmol/L); Below range, as defined by IG \<54 mg/dL (\<3 mmol/L)
| Participants | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | Outpatient Phase: Overall |
|---|---|---|---|---|
| Below range <=70 mg/dL | 14 | 14 | 12 | 40 |
| Between Range 54-70 mg/dL | 14 | 14 | 12 | 40 |
| Below range <54 mg/dL | 11 | 14 | 9 | 34 |
Insulin use as reported by subject as Change from Outpatient Phase Baseline at Study Weeks 4, 8, and 12
| units of insulin | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
|---|---|---|---|
| Fiasp (Insluin Aspart) - Change from Baseline at Week 4 | -2.80 | 2.60 ± 0.141 | 0.10 |
| Fiasp (Insluin Aspart) - Change from Baseline at Week 8 | — | -2.10 ± 1.353 | — |
| Fiasp (Insluin Aspart) - Change from Baseline at Week 12 | -7.60 | -1.70 ± 4.808 | — |
| Humalog (Insulin Lispro) - Change from Baseline at Week 4 | — | 3.05 ± 1.909 | 6.20 |
| Humalog (Insulin Lispro) - Change from Baseline at Week 8 | 0.90 | 7.20 | 3.20 ± 9.758 |
| Humalog (Insulin Lispro) - Change from Baseline at Week 12 | 0.60 | 1.05 ± 3.041 | -0.85 ± 5.498 |
| NovoRapid (Insulin Aspart) - Change from Baseline at Week 4 | -2.43 ± 1.559 | -1.57 ± 2.558 | -2.85 ± 3.041 |
| NovoRapid (Insulin Aspart) - Change from Baseline at Week 8 | -0.15 ± 3.901 | -2.85 ± 3.834 | — |
| NovoRapid (Insulin Aspart) - Change from Baseline at Week 12 | -0.05 ± 10.872 | -4.20 | — |
Change from Baseline to End of the Outpatient Phase in Score on Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1) Questionnaire A total of 12 factors were scored from 1=unlikely (min.) to 7=extremely likely (max.) for their propensity to keep the subject from practicing regular physical exercise during the next 6 months. Lower scores are considered better, while higher scores are considered worse outcomes. The higher the score (1 to 7), the less likely the subject was to engage in exercise. The mean of the scores of the 12 factors were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 7.
| score on a scale | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
|---|---|---|---|
| Baseline BAPAD-1 (Study Visit 3) | 2.25 ± 0.894 | 2.17 ± 0.857 | 2.59 ± 0.957 |
| Change from Baseline at Follow-up in BAPAD-1 (Study Visit 11) | 0.01 ± 0.988 | -0.38 ± 0.781 | -0.34 ± 0.890 |
| Change from Baseline at Early Termination in BAPAD-1 | — | — | -1.00 ± 0.141 |
Change from Baseline in Score on Hypoglycemia Fear Survey-II (HFS-II) A total of 33 items were scored from 0=never (min.) to 4=almost always (max.) for how often in the past 6 months they had done the following: Behavior (15 items): things that people with diabetes often do to avoid low blood sugar. Worry (18 items): things that people with diabetes often worry about because of low blood sugar. Lower scores are considered better outcomes, higher scores are considered worse outcomes. The higher the score (0 to 4), the greater the subject's fear of hypoglycemia. The mean of the scores of the 33 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 0 to 4.
| score on a scale | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
|---|---|---|---|
| Baseline | 1.28 ± 0.293 | 1.16 ± 0.479 | 1.50 ± 0.746 |
| Change from Baseline at Follow-up (Visit 11) | -0.19 ± 0.424 | -0.01 ± 0.290 | -0.03 ± 0.280 |
| Change from Baseline at Early Termination | — | — | -0.60 ± 0.849 |
Change from Baseline in Score on Hypoglycemia Confidence Scale (HCS) The 9-item scale assessed a subject's confidence about safety regarding hypoglycemia. The questionnaire had 4 responses possible for each question, ranging from 1=not confident at all (min.) to 4=very confident (max.). Higher scores are considered better outcomes, while lower scores are considered worse outcomes. The lower the score (1 to 4), the less likely the subject was to engage in exercise. The mean of the scores of the 9 items were calculated for each subject and the overall mean for the subjects was calculated at a group level with overall mean and standard deviation calculated at Baseline (Visit 3) and Follow-up/Early Termination (Visit 11) to calculate change from Baseline. Subject level and overall means could range from 1 to 4.
| score on a scale | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Glucagon RTU Without Insulin Pump Reduction |
|---|---|---|---|
| Baseline | 3.23 ± 0.541 | 3.34 ± 0.616 | 3.20 ± 0.447 |
| Change from Baseline at Follow-up (Visit 11) | 0.07 ± 0.413 | 0.17 ± 0.298 | 0.20 ± 0.357 |
| Change from Baseline at Early Termination | — | — | 0.15 ± 0.778 |
Mean incidence rate of hypoglycemia during or after moderate to high intensity aerobic exercise at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. Incidence rate is defined as the number of hypoglycemic events divided by the total number of qualified exercise sessions, assessed at group level. Qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. Hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
| events/session | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | CRC Phase: Overall |
|---|---|---|---|
| CRC Phase: Incidence Rate of Hypoglycemia During and After Moderate to High Intensity Aerobic Exercise Exercise. | 0.02 | 0.19 | 0.11 |
CRC Phase: Mean number of hypoglycemic events associated with the qualified exercise sessions at each CRC Phase visit. With crossover, each subject had 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) assessed at group level. A qualified exercise session is: (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session. A hypoglycemic event defined as any hypoglycemic event occurring within 30 (+2) min after completion of a qualified exercise session.
| number of events/participant | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | CRC Phase: Overall |
|---|---|---|---|
| CRC Phase: Mean Number of Hypoglycemic Events Exercise. | 0.02 | 0.19 | 0.21 |
Mean number of high intensity aerobic exercise sessions at each CRC Phase visit. With crossover, each subject was to have 2 exercise sessions; 1 visit and exercise session with each treatment (the combined data are presented in the Overall category) and assessed at the group level. A qualified exercise session was defined as one where (1) confirmed blood glucose of 100-180 mg/dL prior to start of exercise, (2) study drug administered no more than 10 min prior to exercise (5 min target), (3) conducted exercise of moderate to high intensity for at least 30 min and no longer than 75 min, and (4) achieved a target heart rate of 80% of maximum calculated heart rate at least once during session.
| mean number of sessions/participant | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | CRC Phase: Overall |
|---|---|---|---|
| CRC Phase: Mean Number of Qualified High Intensity Aerobic Exercise Sessions | 1 | 1 | 1.94 |
Collected over From signing of Informed Consent Form through the followup visit (week 12). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CRC Phase: Glucagon RTU With Insulin Pump Reduction | 0/46 (0%) | 0/46 (0%) | 27/46 (58.7%) |
| CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | 0/47 (0%) | 0/47 (0%) | 30/47 (63.8%) |
| Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| Event | CRC Phase: Glucagon RTU With Insulin Pump Reduction | CRC Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Vehicle for Glucagon RTU With Insulin Pump Reduction | Outpatient Phase: Glucagon RTU Without Insulin Pump Reduction |
|---|---|---|---|---|---|
| Injection site painGeneral disorders | 15/46 | 18/47 | 6/16 | 8/14 | 3/14 |
| Upper respiratory tract infectionInfections and infestations | 1/46 | 2/47 | 1/16 | 2/14 | 0/14 |
| NasopharyngitisInfections and infestations | 0/46 | 2/47 | 0/16 | 1/14 | 2/14 |
| Urinary tract infectionInfections and infestations | 0/46 | 1/47 | 1/16 | 0/14 | 2/14 |
| NauseaGastrointestinal disorders | 2/46 | 1/47 | 2/16 | 1/14 | 2/14 |
| VomitingGastrointestinal disorders | 1/46 | 0/47 | 1/16 | 2/14 | 0/14 |
| FallInjury, poisoning and procedural complications | 0/46 | 0/47 | 0/16 | 2/14 | 1/14 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/46 | 0/47 | 0/16 | 2/14 | 2/14 |
| Injection site discomfortGeneral disorders | 4/46 | 1/47 | 1/16 | 1/14 | 1/14 |
| DizzinessNervous system disorders | 4/46 | 1/47 | 1/16 | 0/14 | 1/14 |
Baseline information is presented for the Safety population for the CRC Phase (Period 1) of the study, this includes all randomized subjects who received at least one dose of study drug.
| Age, Categorical(Participants) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 24 | 48 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| Mean | 39.8 ± 11.47 | 34.7 ± 10.54 | 37.3 ± 11.20 |
| Sex: Female, Male(Participants) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| Female | 9 | 14 | 23 |
| Male | 15 | 10 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 24 | 22 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 19 | 20 | 39 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| United States | 24 | 24 | 48 |
| Weight(kg) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| Mean | 82.15 ± 16.344 | 75.91 ± 16.769 | 79.03 ± 16.681 |
| BMI(kg/m^2) | Glucagon RTU Crossover to Placebo | Placebo Crossover to Glucagon RTU | Total |
|---|---|---|---|
| Mean | 27.051 ± 4.6277 | 26.515 ± 4.7469 | 26.783 ± 4.6454 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2019 to primary completion in Apr 2020, 7 months.
Results were first posted in Aug 2023, 3 years 4 months after primary completion.
Of 24 phase 2 interventional studies under Hypoglycemia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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Xeris Pharmaceuticals