A Phase 2 interventional study of MEDI0382 and Placebo in Type 2 Diabetes Mellitus, sponsored by MedImmune LLC. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 115 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by MedImmune LLC (part of AstraZeneca) · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 15 studies testing cotadutide in Diabetes Mellitus, Type 2 — none open to participants now, none under way, none of them phase 3. cotadutide · Diabetes Mellitus, Type 2.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, this one is the 7th largest by enrollment, is one of 5 that started in 2018, is one of 9 in phase 2, and was the 6th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →None of the 15 studies testing cotadutide in Diabetes Mellitus, Type 2 is open now. The open studies under Diabetes Mellitus, Type 2, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 115 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10
First in 2015; this study’s year is marked. 5 started in 2018.
This study's enrollment of 49 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 41 across the 15 interventional studies. Of the 15 that completed or were terminated, 10 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 15 have an industry lead sponsor. The 2 most frequent:
This study is registered under MedImmune LLC, one of the names counted as AstraZeneca. Under that name alone:
MedImmune LLC is the lead sponsor of 270 studies on the registry; none are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 29 (56%) have results posted.
345 studies in Diabetes Mellitus, Type 2 by AstraZeneca: 13 open now, 15 under way, 9 of them phase 3. Of 325 finished, 149 (46%) have results posted.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 194th largest by enrollment of the 280 interventional ones that give a count, is one of 9 that started in 2018, is one of 41 in phase 2, and was the 290th registered.
AstraZeneca’s Diabetes Mellitus, Type 2 studies by the year they started, since 2001.
None of the studies under way reaches primary completion within a year.
Among the 15 studies testing cotadutide in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 345 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM).
This is an exploratory randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MEDI0382 versus placebo in overweight/obese participants with T2DM treated with metformin and dapagliflozin dual therapy. The study will enroll participants with T2DM treated either with metformin monotherapy or with metformin and dapagliflozin dual therapy. After the screening period, participants treated with metformin monotherapy only will enter a 4-week run-in period where participants will be administered oral dapagliflozin 10 mg a day, which will be provided by the sponsor. Enrolled participants that are already treated with metformin and dapagliflozin dual therapy will continue this dual therapy throughout the study and can be randomized after the screening period without entering the run-in period. All participants (ie, on monotherapy and dual therapy) entering the double-blind treatment period will receive dapagliflozin 10 mg a day, which will be provided by the sponsor.
Participants in this study will participate for up to 20 weeks including a screening period of up to 60 days, a 4-week run-in period (for participants on metformin monotherapy only), a 4-week treatment period, and a 4-week follow-up post-treatment period.
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:
Any participant who has received any of the following medications prior to the start of the screening period (Visit 1) or prior to the study start period (Visit 4):
Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
Poorly controlled hypertension as defined below:
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 authorized 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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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, colors or preservatives.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
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.
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 authorized 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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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, colors or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
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.
Participants will receive subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period.
Drug: MEDI0382 · Drug: Dapaglifozin · Drug: Metformin
Participants will receive subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period
Drug: Placebo · Drug: Dapaglifozin · Drug: Metformin
Subcutaneous dose of MEDI0382 (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days).
Subcutaneous dose of placebo matched to MEDI0382.
Oral dose of dapaglifozin 10 mg tablet.
Oral dose of metformin tablet (maximum tolerated dose \[MTD\] \> 1 g).
Change From Baseline to Day 28 in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4hrs) as Measured by Mixed-meal Tolerance Test (MMTT)
The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein) within 5 minutes. On Day -1 and on Day 28, following a minimum 10 hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28
Percent Change From Baseline to Day 28 in Plasma Glucose AUC0-4hrs as Measured by MMTT
The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein)within 5 minutes. On Day -1 and on Day 28, following a minimum 10-hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).
Time frame: Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Reported as TEAEs
Number of participants with abnormal 12-lead ECG reported as TEAEs are reported.
Time frame: Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Number of participants with abnormal vital signs reported as TEAEs are reported.
Time frame: Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)
Number of Participants With Abnormal Physical Examinations Reported as TEAEs
Number of participants with abnormal physical examinations reported as TEAEs are reported.
Time frame: Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
Time frame: Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of MEDI0382
Area under the plasma concentration time curve from time zero to infinity (AUC \[0-∞\]) of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of Dapagliflozin
Area under the plasma concentration time curve from time zero to infinity (AUC \[0-∞\]) of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of MEDI0382
Area under the plasma concentration-time curve during the dosing period (AUCtau) of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of Dapagliflozin
Area under the plasma Concentration-time curve during the dosing period (AUCtau) of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Maximum Observed Serum Concentration (Cmax) of MEDI0382
Maximum observed serum concentration (Cmax) of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Maximum Observed Serum Concentration (Cmax) of Dapagliflozin
Maximum observed serum concentration (Cmax) of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI0382
Time to reach maximum observed serum concentration (Tmax) of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Time to Reach Maximum Observed Serum Concentration (Tmax) of Dapagliflozin
Time to reach maximum observed serum concentration (Tmax) of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Terminal Elimination Half-life (t½) of MEDI0382
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Terminal Elimination Half-life (t½) of Dapagliflozin
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Apparent Clearance (CL/F) of MEDI0382
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of MEDI0382 is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28
Apparent Clearance (CL/F) of Dapagliflozin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of Dapagliflozin is reported.
Time frame: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28
Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI0382
Number of participants with positive Anti-drug antibodies (ADA) titer to MEDI0382 are reported.
Time frame: Day 1 (pre-dose), on Day 29 , and 28 days post last dose (end of study visit; approximately 8 weeks)
Change From Baseline in Plasma Glucose AUC24-hrs to the End of Each Dosing Level as Measured by Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in Mean 24-hrs Plasma Glucose to the End of Each Dosing Level as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in Standard Deviation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in Coefficient of Variation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in Mean Amplitude of Glucose Excursions (MAGE) of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Euglycemic Range to the End of Each Dosing as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Euglycemic range is defined as glucose levels of \>= 70 mg/dL (\>= 3.9 mmol/L) and \<= 180 mg/dL (\<= 10.0 mmol/L).
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hyperglycemic Range to the End of Each Dosing as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hyperglycemic (high glucose) range is defined as glucose levels of \> 180 mg/dL (\> 10.0 mmol/L).
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hypoglycemic Range to the End of Each Dosing as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hypoglycemic range is defined as glucose levels of \< 70 mg/dL (\< 3.9 mmol/L).
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within Clinically Significant Hypoglycemic Range to the End of Each Dosing as Measured by CGM
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Clinically significant hypoglycemic range is defined as glucose levels of \< 54 mg/dL (3.0 mmol/L).
Time frame: Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg
The study was conducted in Germany and Hungary between 08May2018 and 06Dec2018.
| Milestone | Placebo | MEDI0382 |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 23 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Other | 0 | 1 |
The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein) within 5 minutes. On Day -1 and on Day 28, following a minimum 10 hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).
| hr·mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Change From Baseline to Day 28 in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4hrs) as Measured by Mixed-meal Tolerance Test (MMTT) | -11.28 (-51.05 to 28.50) | -154.37 (-192.45 to -116.29) |
The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein)within 5 minutes. On Day -1 and on Day 28, following a minimum 10-hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).
| Percent change in Glucose AUC0-4hrs | Placebo | MEDI0382 |
|---|---|---|
| Percent Change From Baseline to Day 28 in Plasma Glucose AUC0-4hrs as Measured by MMTT | -0.13 (-5.96 to 5.69) | -22.30 (-27.88 to -16.73) |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| TEAEs | 14 | 13 |
| TESAEs | 0 | 0 |
Number of participants with abnormal 12-lead ECG reported as TEAEs are reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Reported as TEAEs | 0 | 0 |
Number of participants with abnormal vital signs reported as TEAEs are reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Tachycardia | 2 | 1 |
| Tachycardia paroxysmal | 1 | 0 |
| Palpitations | 0 | 1 |
Number of participants with abnormal physical examinations reported as TEAEs are reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Number of Participants With Abnormal Physical Examinations Reported as TEAEs | 0 | 0 |
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Hypoglycemia | 1 | 0 |
Area under the plasma concentration time curve from time zero to infinity (AUC \[0-∞\]) of MEDI0382 is reported.
| ng.hr/mL | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 106.4 (57.7 to 251.8) |
| Day 14 ( MEDI0382 200 µg) | 196.7 (99.4 to 472.0) |
| Day 28 (MEDI0382 300 µg) | 314.6 (211.0 to 537.3) |
Area under the plasma concentration time curve from time zero to infinity (AUC \[0-∞\]) of Dapagliflozin is reported.
| ng.hr/mL | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 432.6 (271.5 to 918.6) | 473.8 (288.8 to 1073.2) |
| Day 7 | 410.2 (209.9 to 1024.2) | 438.0 (222.2 to 833.6) |
| Day 14 | 421.0 (219.0 to 1327.8) | 448.6 (247.0 to 615.9) |
| Day 28 | 405.7 (261.1 to 799.5) | 523.4 (319.5 to 946.0) |
Area under the plasma concentration-time curve during the dosing period (AUCtau) of MEDI0382 is reported.
| ng.hr/mL | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 89.6 (43.1 to 199.4) |
| Day 14 ( MEDI0382 200 µg) | 165.0 (86.9 to 365.5) |
| Day 28 (MEDI0382 300 µg) | 265.9 (101.7 to 795.1) |
Area under the plasma Concentration-time curve during the dosing period (AUCtau) of Dapagliflozin is reported.
| ng.hr/mL | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 400.9 (182.4 to 1011.5) | 430.3 (252.5 to 815.2) |
| Day 7 | 377.5 (76.4 to 910.7) | 406.8 (211.5 to 1142.6) |
| Day 14 | 417.1 (209.0 to 1107.7) | 396.8 (215.4 to 669.7) |
| Day 28 | 423.1 (180.6 to 977.3) | 463.8 (284.3 to 1245.7) |
Maximum observed serum concentration (Cmax) of MEDI0382 is reported.
| ng/mL | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 5.2 (2.7 to 11.9) |
| Day 14 ( MEDI0382 200 µg) | 10.1 (4.4 to 21.7) |
| Day 28 (MEDI0382 300 µg) | 17.2 (6.1 to 45.4) |
Maximum observed serum concentration (Cmax) of Dapagliflozin is reported.
| ng/mL | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 110.1 (46.3 to 208.3) | 116.7 (38.2 to 206.8) |
| Day 7 | 92.0 (5.2 to 256.7) | 84.4 (24.1 to 211.7) |
| Day 14 | 95.6 (33.5 to 280.7) | 61.1 (15.8 to 149.9) |
| Day 28 | 112.2 (47.0 to 235.4) | 94.2 (25.2 to 182.2) |
Time to reach maximum observed serum concentration (Tmax) of MEDI0382 is reported.
| Hours | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 5.5 (2 to 8) |
| Day 14 ( MEDI0382 200 µg) | 5.1 (2 to 8) |
| Day 28 (MEDI0382 300 µg) | 4 (1.9 to 8.1) |
Time to reach maximum observed serum concentration (Tmax) of Dapagliflozin is reported.
| Hours | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 1 (0.5 to 2) | 1 (0.4 to 23.9) |
| Day 7 | 1 (0.5 to 11.4) | 1 (0.5 to 4) |
| Day 14 | 1.1 (0.5 to 6) | 1 (0 to 8.1) |
| Day 28 | 1 (0.2 to 1.8) | 1 (0.5 to 8.1) |
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI0382 is reported.
| Hours | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 8.8 (6.1 to 11.9) |
| Day 14 ( MEDI0382 200 µg) | 9 (5.6 to 11.8) |
| Day 28 (MEDI0382 300 µg) | 9.1 (5.1 to 11.6) |
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of Dapagliflozin is reported.
| Hours | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 8.2 (5.3 to 11.2) | 7.8 (5.4 to 11.3) |
| Day 7 | 7.9 (4.1 to 10.4) | 8.3 (5.8 to 11.1) |
| Day 14 | 7.0 (5.1 to 11.4) | 8.5 (7 to 10) |
| Day 28 | 7.6 (5.8 to 11.0) | 9.1 (6.1 to 11.8) |
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of MEDI0382 is reported.
| L/hr | MEDI0382 |
|---|---|
| Day 7 (MEDI0382 100 µg) | 1.1 (0.5 to 1.9) |
| Day 14 ( MEDI0382 200 µg) | 1.3 (0.5 to 2.2) |
| Day 28 (MEDI0382 300 µg) | 1.2 (0.8 to 1.8) |
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of Dapagliflozin is reported.
| L/Hr | Placebo | MEDI0382 |
|---|---|---|
| Day -1 | 25.5 (13.3 to 38.9) | 23.3 (12.3 to 39.6) |
| Day 7 | 26.7 (11.0 to 52.8) | 25.7 (14.2 to 47.3) |
| Day 14 | 25.9 (9.0 to 47.7) | 25.5 (18.8 to 46.4) |
| Day 28 | 26.8 (13.8 to 40.2) | 22.2 (13.4 to 35.2) |
Number of participants with positive Anti-drug antibodies (ADA) titer to MEDI0382 are reported.
| Participants | Placebo | MEDI0382 |
|---|---|---|
| Day 1 | 0 | 3 |
| Day 29 | 0 | 1 |
| End of Study | 1 | 2 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
| hr.mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | 49.14 ± 667.30 | -832.66 ± 506.22 |
| Day 14 (MEDI0382 200 μg) | 57.30 ± 379.95 | -666.05 ± 647.63 |
| Day 28 (MEDI0382 300 μg) | 229.47 ± 589.19 | -726.85 ± 710.71 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
| mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | 2.59 ± 28.96 | -34.74 ± 20.34 |
| Day 14 (MEDI0382 200 μg) | 2.83 ± 17.01 | -28.34 ± 27.12 |
| Day 28 (MEDI0382 300 μg) | 9.70 ± 24.73 | -30.55 ± 29.82 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
| mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | -3.01 ± 13.84 | -7.21 ± 11.05 |
| Day 14 (MEDI0382 200 μg) | 1.38 ± 9.47 | -7.52 ± 9.73 |
| Day 28 (MEDI0382 300 μg) | -4.39 ± 10.67 | -9.76 ± 10.18 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
| Percent of coefficient of variation | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | -2.37 ± 9.06 | -0.45 ± 6.68 |
| Day 14 (MEDI0382 200 μg) | 0.96 ± 8.74 | -2.06 ± 6.59 |
| Day 28 (MEDI0382 300 μg) | -4.26 ± 7.16 | -3.21 ± 7.25 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.
| mg/dL | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | -13.46 ± 32.07 | -25.74 ± 35.06 |
| Day 14 (MEDI0382 200 μg) | 18.05 ± 47.60 | -26.59 ± 25.60 |
| Day 28 (MEDI0382 300 μg) | -8.09 ± 27.68 | -27.92 ± 23.17 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Euglycemic range is defined as glucose levels of \>= 70 mg/dL (\>= 3.9 mmol/L) and \<= 180 mg/dL (\<= 10.0 mmol/L).
| Percent of Euglycemic Range | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | -5.61 ± 19.65 | 7.12 ± 20.60 |
| Day 14 (MEDI0382 200 μg) | -2.79 ± 10.16 | 5.31 ± 17.71 |
| Day 28 (MEDI0382 300 μg) | -4.17 ± 15.80 | 6.54 ± 24.37 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hyperglycemic (high glucose) range is defined as glucose levels of \> 180 mg/dL (\> 10.0 mmol/L).
| Percent of hyperglycemic range | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | 3.62 ± 17.80 | -13.99 ± 14.95 |
| Day 14 (MEDI0382 200 μg) | 0.36 ± 10.50 | -9.81 ± 13.68 |
| Day 28 (MEDI0382 300 μg) | 6.08 ± 16.96 | -9.72 ± 20.97 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hypoglycemic range is defined as glucose levels of \< 70 mg/dL (\< 3.9 mmol/L).
| Percent of hypoglycemic range | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | 1.17 ± 5.64 | 6.08 ± 10.36 |
| Day 14 (MEDI0382 200 μg) | 2.00 ± 3.79 | 3.44 ± 12.72 |
| Day 28 (MEDI0382 300 μg) | -2.08 ± 4.14 | 2.84 ± 12.20 |
Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Clinically significant hypoglycemic range is defined as glucose levels of \< 54 mg/dL (3.0 mmol/L).
| Percent of hypoglycemic range | Placebo | MEDI0382 |
|---|---|---|
| Day 7 (MEDI0382 100 μg) | 0.76 ± 3.64 | 1.61 ± 5.03 |
| Day 14 (MEDI0382 200 μg) | 0.27 ± 1.19 | -0.06 ± 2.18 |
| Day 28 (MEDI0382 300 μg) | -0.26 ± 0.90 | 0.93 ± 4.91 |
Collected over Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/24 (0%) | 0/24 (0%) | 14/24 (58.3%) |
| MEDI0382 | 0/25 (0%) | 0/25 (0%) | 13/25 (52%) |
| Event | Placebo | MEDI0382 |
|---|---|---|
| NauseaGastrointestinal disorders | 2/24 | 5/25 |
| VomitingGastrointestinal disorders | 0/24 | 5/25 |
| HeadacheNervous system disorders | 1/24 | 5/25 |
| Viral upper respiratory tract infectionInfections and infestations | 3/24 | 3/25 |
| Abdominal pain upperGastrointestinal disorders | 0/24 | 3/25 |
| ConstipationGastrointestinal disorders | 0/24 | 3/25 |
| TachycardiaCardiac disorders | 2/24 | 1/25 |
| DiarrhoeaGastrointestinal disorders | 2/24 | 1/25 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 2/24 | 0/25 |
| DizzinessNervous system disorders | 0/24 | 2/25 |
As-treated population included all participants who received any dose of study drugs and analyzed according to the treatment they actually received.
| Age, Continuous(Years) | Placebo | MEDI0382 | TOTAL |
|---|---|---|---|
| Mean | 58.4 ± 10.0 | 61.0 ± 8.2 | 59.7 ± 9.1 |
| Sex: Female, Male(Participants) | Placebo | MEDI0382 | TOTAL |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 12 | 15 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | MEDI0382 | TOTAL |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 23 | 25 | 48 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | MEDI0382 | TOTAL |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 24 | 25 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from May 2018 to primary completion in Dec 2018, 6 months.
Results were first posted in Jan 2020, 1 year 1 month after primary completion.
Of 194 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 6 months is below that.
Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. 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: Cotadutide