A Phase 1/2 interventional study of glucagon and Closed loop glucagon pump in Post-bariatric Hypoglycemia, sponsored by Joslin Diabetes Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Joslin Diabetes Center · Phase 1/2, Interventional, and Prevention
Among 32 studies testing glucagon in Hypoglycemia — 1 open to participants now, 2 under way, none of them phase 3. Glucagon · Hypoglycemia.
Among the 32 studies testing glucagon in Hypoglycemia, this one is the 15th largest by enrollment of the 31 interventional ones, is one of 4 that started in 2017, is the only one in phase 1/2, and was the 21st registered.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's enrollment of 18 is below the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →1 of the 32 studies testing glucagon in Hypoglycemia is open now, in 1 country. Each count lists the studies.
Glucagon: first FDA approval 1960 (GLUCAGON), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
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 65 Years · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2017.
Median enrollment 18 across the 31 interventional studies. Of the 27 that completed or were terminated, 19 (70%) have results posted.
18 of 32 have an industry lead sponsor. The 10 most frequent:
Joslin Diabetes Center is the lead sponsor of 80 studies on the registry; 7 are open to participants now.
15 studies in Hypoglycemia by Joslin Diabetes Center: 2 open now, 6 under way, none of them phase 3. Of 9 finished, 4 (44%) have results posted.
Among the 15 studies in Hypoglycemia by Joslin Diabetes Center, this one is one of 2 that started in 2017, is the only one in phase 1/2, and was the 4th registered.
Joslin Diabetes Center’s Hypoglycemia studies by the year they started, since 2010.
1 of the studies testing glucagon in Hypoglycemia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07818707Joslin Diabetes CenterPost-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH) | 2027-01 |
Among the 32 studies testing glucagon in Hypoglycemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Joslin Diabetes Center’s 15 in Hypoglycemia:
Nothing recorded among them since 2026-09-25.
To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.
A control system for sensor-guided delivery was previously developed and tested in a Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance tests in 8 unique patients with severe hypoglycemia following bariatric surgery. This optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop system.
A randomized, placebo-controlled, masked trial will be conducted to assess the efficacy of the closed loop system to prevent and treat hypoglycemia occurring in patients with PBH in response to meals (part 1). Part 2 will test whether the closed loop system can also prevent and treat hypoglycemia in patients with PBH in response to exercise. A manufacturing program from our collaborating team at Xeris Pharmaceuticals will continue to produce supplies of glucagon for the clinical trial in a current good manufacturing practice (cGMP) facility, with continued shelf-life stability testing.
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.
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.
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.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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 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.
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.
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.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session.
Drug: glucagon · Device: Closed loop glucagon pump
Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session.
Device: Closed loop glucagon pump
novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals
a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <65 mg/dL
A primary endpoint for this study is the prevention of meal provoked hypoglycemia, defined as sensor glucose levels below \<65 mg/dl, comparing study drug to control.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <65 mg/dL
A primary endpoint for this study is prevention of meal provoked hypoglycemia, defined as plasma glucose levels below \<65 mg/dl, comparing study drug to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <60 mg/dL
Prevention of meal / provoked hypoglycemia, defined as sensor glucose levels below \<60 mg/dl, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Rebound Hyperglycemia (Defined as Glucose Levels Above 180 mg/dl).
Compare outcomes for glucagon versus vehicle infusions for prevention of rebound hyperglycemia (defined as glucose levels above 180 mg/dl).
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge will be conducted within two weeks of the first.
Number of Participants With Hypoglycemia Rescue Administered
Protocol-specified rescue delivery of IV glucose was performed if plasma glucose \<55 mg/dL and/or significant neuroglycopenia developed.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <60 mg/dL
Prevention of meal / provoked hypoglycemia, defined as plasma glucose levels below \<60 mg/dl, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <55 mg/dL
Prevention of meal / provoked hypoglycemia, defined as plasma glucose levels below \<55 mg/dl, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <55 mg/dL
Prevention of meal / provoked hypoglycemia, defined as sensor glucose levels below \<55 mg/dl, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Percent Time Plasma Glucose in Range After the Final Dose of Study Drug or Vehicle, Which Was Either 1 or 2 Doses Depending on Patient Response
Compare outcomes for glucagon versus vehicle infusions for percent time plasma glucose in range (180-65mg/dL) after the final dose, which was either 1 or 2 doses depending on patient response
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Percent Time Sensor Glucose in Range After Drug Delivery After the Final Dose of Study Drug or Vehicle, Which Was Either 1 or 2 Doses Depending on Patient Response
Compare outcomes for glucagon versus vehicle infusions for percent time sensor glucose in range (180-65mg/dL) after the final dose, which was either 1 or 2 doses depending on patient response
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Meal Provoked Nadir Plasma Glucose
Nadir plasma glucose (mg/dl) during meal testing, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Meal Provoked Nadir Sensor Glucose
Nadir sensor glucose (mg/dl) during meal testing, comparing vehicle to control
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Time to Nadir Plasma Glucose After Mixed Meal (Min)
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Time to Nadir Sensor Glucose After Mixed Meal (Min)
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Time to Alarm During Mixed Meal Testing (Minutes)
Time to alarm represents the time for the first alarm to occur during mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Time to Delivery (Min)
Time to delivery (min) of study drug during mixed meal testing
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Sensor Glucose at Time of Alarm 1 During Mixed Meal Testing (mg/dL)
This is the sensor glucose at which time the first alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Capillary Glucose at Time of Alarm 1 During Mixed Meal Testing (mg/dL)
This is the capillary glucose at which time the first alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Sensor Glucose at Time of Alarm 2 During Mixed Meal Testing (mg/dL)
This is the sensor glucose at which time the second alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Capillary Glucose at Time of Alarm 2 During Mixed Meal Testing (mg/dL)
This is the capillary glucose at which time the second alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
Time frame: Measured following 2 challenges: 1 with glucagon and 1 with vehicle. The second challenge was conducted within two weeks of the first.
Pain Score at Time of First Dose Delivery of Study Drug, Versus Pain Score at Time of First Dose Delivery of Placebo (Comparing First Delivery Pain Scores for Visit Where Participant Received Study Drug vs. Visit Where Participant Received Placebo).
Pain score was assessed verbally, 1 is the least pain (none), 10 is the most severe pain. Pain score at the time of the first administration was compared for the visit where the participant received the study drug vs. the visit where the participant received the placebo. A participant could receive 2 doses of the study drug or placebo at each visit. All 12 participants completed both the study drug phase and the placebo phase. The pain scores for the first administration of study drug vs. first administration of placebo for these two visits were compared. Whether the participant was assigned to the study drug glucagon (vs. placebo) at the first or second MMTT was determined by randomization.
Time frame: The two study visits where participants were administered either study drug or placebo took place over 2 weeks (there was a 1 to 2 week washout period between visits).
Pain Score at Time of Second Dose Delivery of Study Drug, Versus Pain Score at Time of Second Dose Delivery of Placebo (Comparing Second Delivery Pain Scores for Visit Where Participant Received Study Drug vs. Visit Where Participant Received Placebo).
Pain score was assessed verbally, 1 is the least pain (none), 10 is the most severe pain. Pain score at the time of the second administration was compared for the visit where the participant received the study drug vs. the visit where the participant received the placebo. A participant could receive 2 doses of the study drug or placebo at each visit. All 12 participants completed both the study drug phase and the placebo phase. The pain scores from the second administration of study drug vs. second administration of placebo for these two visits were compared. Whether the participant was assigned to the study drug glucagon (vs. placebo) at the first or second MMTT was determined by randomization.
Time frame: The two study visits where participants were administered either study drug or placebo took place over 2 weeks (there was a 1 to 2 week washout period between visits).
Participants with a history of Roux-en-Y gastric bypass (RYGB) and post-bariatric hypoglycemia (PBH) with neuroglycopenia, uncontrolled on medical nutrition therapy and medications, were recruited from the Joslin Diabetes Center hypoglycemia clinic and other endocrine clinics in the region.
| Milestone | Study Drug (Glucagon) First, Then Placebo (Randomized, Double-blind, Crossover Design) | Placebo First, Then Study Drug (Glucagon) Second (Randomized, Double-blind, Crossover Design) |
|---|---|---|
| Started | 8 | 8 |
| Completed | 5 | 7 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Did not experience hypoglycemia | 2 | 1 |
A primary endpoint for this study is the prevention of meal provoked hypoglycemia, defined as sensor glucose levels below \<65 mg/dl, comparing study drug to control.
| participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <65 mg/dL | 1 | 5 |
A primary endpoint for this study is prevention of meal provoked hypoglycemia, defined as plasma glucose levels below \<65 mg/dl, comparing study drug to control
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <65 mg/dL | 1 | 4 |
Prevention of meal / provoked hypoglycemia, defined as sensor glucose levels below \<60 mg/dl, comparing vehicle to control
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <60 mg/dL | 1 | 3 |
Compare outcomes for glucagon versus vehicle infusions for prevention of rebound hyperglycemia (defined as glucose levels above 180 mg/dl).
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Rebound Hyperglycemia (Defined as Glucose Levels Above 180 mg/dl). | 0 | 0 |
Protocol-specified rescue delivery of IV glucose was performed if plasma glucose \<55 mg/dL and/or significant neuroglycopenia developed.
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Hypoglycemia Rescue Administered | 0 | 7 |
Prevention of meal / provoked hypoglycemia, defined as plasma glucose levels below \<60 mg/dl, comparing vehicle to control
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <60 mg/dL | 0 | 3 |
Prevention of meal / provoked hypoglycemia, defined as plasma glucose levels below \<55 mg/dl, comparing vehicle to control
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <55 mg/dL | 0 | 5 |
Prevention of meal / provoked hypoglycemia, defined as sensor glucose levels below \<55 mg/dl, comparing vehicle to control
| Participants | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <55 mg/dL | 0 | 0 |
Compare outcomes for glucagon versus vehicle infusions for percent time plasma glucose in range (180-65mg/dL) after the final dose, which was either 1 or 2 doses depending on patient response
| percentage of time | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Percent Time Plasma Glucose in Range After the Final Dose of Study Drug or Vehicle, Which Was Either 1 or 2 Doses Depending on Patient Response | 0.852 ± 0.082 | 0.645 ± 0.074 |
Compare outcomes for glucagon versus vehicle infusions for percent time sensor glucose in range (180-65mg/dL) after the final dose, which was either 1 or 2 doses depending on patient response
| percentage of time | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Percent Time Sensor Glucose in Range After Drug Delivery After the Final Dose of Study Drug or Vehicle, Which Was Either 1 or 2 Doses Depending on Patient Response | 0.987 ± 0.013 | 0.815 ± 0.077 |
Nadir plasma glucose (mg/dl) during meal testing, comparing vehicle to control
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Meal Provoked Nadir Plasma Glucose | 67.4 ± 2.70 | 58.5 ± 1.87 |
Nadir sensor glucose (mg/dl) during meal testing, comparing vehicle to control
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Meal Provoked Nadir Sensor Glucose | 72.7 ± 2.21 | 65.3 ± 1.85 |
| minutes | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Time to Nadir Plasma Glucose After Mixed Meal (Min) | 138 ± 11.9 | 125 ± 7.43 |
| minutes | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Time to Nadir Sensor Glucose After Mixed Meal (Min) | 156 ± 11.6 | 134 ± 6.04 |
Time to alarm represents the time for the first alarm to occur during mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
| minutes | Study Drug (Glucagon) Phase | Placebo / Control Arm |
|---|---|---|
| Time to Alarm During Mixed Meal Testing (Minutes) | 89.9 ± 3.90 | 87.7 ± 4.9975 |
Time to delivery (min) of study drug during mixed meal testing
| minutes | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Time to Delivery (Min) | 94 ± 5.52 | 89.3 ± 5.33 |
This is the sensor glucose at which time the first alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Sensor Glucose at Time of Alarm 1 During Mixed Meal Testing (mg/dL) | 134 ± 5.93 | 139 ± 4.92 |
This is the capillary glucose at which time the first alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Capillary Glucose at Time of Alarm 1 During Mixed Meal Testing (mg/dL) | 98.1 ± 7.30 | 109 ± 5.75 |
This is the sensor glucose at which time the second alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Arm |
|---|---|---|
| Sensor Glucose at Time of Alarm 2 During Mixed Meal Testing (mg/dL) | 85.7 ± 4.96 | 70.1 ± 2.26 |
This is the capillary glucose at which time the second alarm occurred during the mixed meal testing. Alarms are triggered by hypoglycemia (sensor glucose \< 65 mg/dL), or by the algorithm predicting that hypoglycemia will occur in less than 30 minutes (taking into account current sensor glucose level (between 65-150 mg/dL) and the rate of change of a rapidly falling sensor glucose level). In the latter case, the alarm is activated even if glucose levels are within the normoglycemic range to allow early detection and response. During both glucagon and vehicle treatment visits, all participants received either 300 μg of glucagon or the equivalent volume of vehicle with the first alarm.
| mg/dL | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Capillary Glucose at Time of Alarm 2 During Mixed Meal Testing (mg/dL) | 94.2 ± 1.70 | 91.7 ± 8.62 |
Pain score was assessed verbally, 1 is the least pain (none), 10 is the most severe pain. Pain score at the time of the first administration was compared for the visit where the participant received the study drug vs. the visit where the participant received the placebo. A participant could receive 2 doses of the study drug or placebo at each visit. All 12 participants completed both the study drug phase and the placebo phase. The pain scores for the first administration of study drug vs. first administration of placebo for these two visits were compared. Whether the participant was assigned to the study drug glucagon (vs. placebo) at the first or second MMTT was determined by randomization.
| pain score | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Pain Score at Time of First Dose Delivery of Study Drug, Versus Pain Score at Time of First Dose Delivery of Placebo (Comparing First Delivery Pain Scores for Visit Where Participant Received Study Drug vs. Visit Where Participant Received Placebo). | 4.00 ± 0.685 | 3.83 ± 0.815 |
Pain score was assessed verbally, 1 is the least pain (none), 10 is the most severe pain. Pain score at the time of the second administration was compared for the visit where the participant received the study drug vs. the visit where the participant received the placebo. A participant could receive 2 doses of the study drug or placebo at each visit. All 12 participants completed both the study drug phase and the placebo phase. The pain scores from the second administration of study drug vs. second administration of placebo for these two visits were compared. Whether the participant was assigned to the study drug glucagon (vs. placebo) at the first or second MMTT was determined by randomization.
| pain score | Study Drug (Glucagon) Phase | Placebo / Control Phase |
|---|---|---|
| Pain Score at Time of Second Dose Delivery of Study Drug, Versus Pain Score at Time of Second Dose Delivery of Placebo (Comparing Second Delivery Pain Scores for Visit Where Participant Received Study Drug vs. Visit Where Participant Received Placebo). | 1.14 ± 0.615 | 1.31 ± 0.671 |
Collected over Adverse event data were collected over the the duration of each individuals participation, a 2 to 3 week period of time, encompassing the time of enrollment, to the completion of visit 5.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm and Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) | 0/18 (0%) | 1/18 (5.6%) | 16/18 (88.9%) |
| Event | Treatment Arm and Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| HypokalemiaMetabolism and nutrition disorders | 1/18 |
| Event | Treatment Arm and Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Hypoglycemia during study (MMTT)Endocrine disorders | 13/18 |
| Buring pain at pump site after alarm (glucagon visit)General disorders | 13/18 |
| Nausea after intake of mixed meal (prior to glucagon OR placebo)Gastrointestinal disorders | 12/18 |
| Tiredness after intake of mixed meal (prior to study drug OR placebo)General disorders | 11/18 |
| Erythema at pump infusion site (glucagon visit)Skin and subcutaneous tissue disorders | 11/18 |
| Burning pain / pricking at pump site after alarm (placebo visit)General disorders | 10/18 |
| Erythema at pump infusion site (placebo visit)Skin and subcutaneous tissue disorders | 10/18 |
| Headache after intake of mixed meal (prior to glucagon OR placebo)General disorders | 7/18 |
| Palpitations after intake of mixed meal (prior to study drug OR placebo)Cardiac disorders | 6/18 |
| Feeling hot / warm after intake of mixed meal (prior to study drug or placebo)General disorders | 6/18 |
Demographic Information for 12 Enrolled Participants Who Completed 2 Mixed-Meal Study Visits and Were Included in the Analysis
| Age, Continuous(years) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Mean | 52 ± 2.4 |
| Sex: Female, Male(Participants) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Female | 11 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| BMI(kg/m^2) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Mean | 27.6 ± 1.5 |
| Years since surgery(years) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Mean | 8.4 ± 1.5 |
| Years from surgery to neuroglycopenia(years) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Median | 2.2 (1.4 to 6.1) |
| HbA1c(percent) | Treatment Arm / Control Arm (Randomized, Double-Blind, Placebo-Controlled Crossover Design) |
|---|---|
| Mean | 5.3 ± 0.1 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Aug 2018, 11 months.
Results were first posted in Jul 2022, 3 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glucagon
Joslin Diabetes Center