Primary outcomeLeast squares mean· From baseline to 14 weeks
Change in HbA1c
| Group | Value (percentage) |
|---|---|
| Placebo | -0.18 |
| MEDI0382 100 mcg | -1.01 |
| MEDI0382 200 mcg | -1.22 |
| MEDI0382 300 mcg | -1.09 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataA Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
NCTNCT03235050 (opens ClinicalTrials.gov in a new tab)Other idD5670C00004
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 834 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Triple masking
- Countries
8 countries
United States, Bulgaria, Canada, Czechia, Germany, Mexico, Russia, Slovakia
- Start
- 2 Aug 2017
- Primary completion
- 3 May 2018
- Completion
- 14 Jun 2019
- First posted
- 1 Aug 2017
- Last update posted
- 17 Aug 2020
- Conditions
- Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2017201820192020
- Ph 2
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
NCT032350502 Aug 2017 to 14 Jun 2019
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382
Interventions
- MEDI0382 low doseDrug
- MEDI0382 mid doseDrug
- MEDI0382 high doseDrug
- PlaceboDrug
- LiraglutideDrug
Arms5
Experimental
MEDI0382 low dose + Metformin
Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Experimental
MEDI0382 mid dose + Metformin
Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Experimental
MEDI0382 high dose + Metformin
Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Placebo comparator
Placebo + Metformin
Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Active comparator
Liraglutide + Metformin
Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in HbA1c
Time frame · From baseline to 14 weeks
Registry description
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Percent Change in Body Weight
Time frame · From baseline to 14 weeks
Registry description
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Secondary outcomes(11)
Change in HbA1c
Time frame · from baseline to 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
Percentage of Participants Achieving an HbA1c Target < 7.0%
Time frame · after 14, 26, and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of participants achieving an HbA1c target of \<7% versus placebo
Percent Change in Body Weight
Time frame · from baseline to 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo
Absolute Change in Body Weight
Time frame · from baseline to 14 weeks, 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Percent Change in Body Weight Versus Active Comparator
Time frame · from baseline to 14 weeks, 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Absolute Change in Body Weight Versus Active Comparator
Time frame · from baseline to 14 weeks, 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus liraglutide 1.8 mg once daily
Percentage of Participants Achieving Weight Loss of ≥5% and ≥10%
Time frame · after 14 weeks, 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on percentage of subjects achieving weight loss of ≥5% and ≥10% versus placebo
Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control
Time frame · at 14 weeks, 26 weeks and 54 weeks
Registry description
To assess the effect of 100, 200, and 300 μg of cotadutide on the requirement for additional blood glucose-lowering therapies versus placebo
Pharmacokinetic (PK) Endpoint: Trough Plasma Concentration (Cmin)
Time frame · Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
Registry description
To characterise the PK profile of 100, 200, and 300 μg of cotadutide
Immunogenicity Endpoint: Overall Antidrug Antibody (ADA) Incidence (Number and Percentage of Positive Partipants)
Time frame · Baseline through 54-week treatment period and 28-day follow-up
Registry description
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Immunogenicity Endpoint: Median Titer of the Anti-Drug Antibodies (ADA) to MEDI0382 in the Positive Participants
Time frame · Baseline through 54-week treatment period and 28-day follow-up
Registry description
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeLeast squares mean· From baseline to 14 weeks
Percent Change in Body Weight
| Group | Value (percentage) |
|---|---|
| Placebo | -0.70 |
| MEDI0382 100 mcg | -2.70 |
| MEDI0382 200 mcg | -3.47 |
| MEDI0382 300 mcg | -4.33 |
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· from baseline to 26 weeks and 54 weeks
Change in HbA1c
| Group | Value (percentage) |
|---|---|
| Placebo | -0.40 |
| MEDI0382 100 mcg | -1.06 |
| MEDI0382 200 mcg | -1.22 |
| MEDI0382 300 mcg | -1.12 |
Secondary outcomeCount of participants· after 14, 26, and 54 weeks
Percentage of Participants Achieving an HbA1c Target < 7.0%
| Group | Value (Participants) |
|---|---|
| Placebo | 19 |
| MEDI0382 100 mcg | 50 |
| MEDI0382 200 mcg | 143 |
| MEDI0382 300 mcg | 143 |
Secondary outcomeLeast squares mean· from baseline to 26 weeks and 54 weeks
Percent Change in Body Weight
| Group | Value (percentage) |
|---|---|
| Placebo | -1.14 |
| MEDI0382 100 mcg | -3.23 |
| MEDI0382 200 mcg | -3.94 |
| MEDI0382 300 mcg | -4.60 |
Secondary outcomeLeast squares mean· from baseline to 14 weeks, 26 weeks and 54 weeks
Absolute Change in Body Weight
| Group | Value (kg) |
|---|---|
| Placebo | -0.71 |
| MEDI0382 100 mcg | -2.66 |
| MEDI0382 200 mcg | -3.45 |
| MEDI0382 300 mcg | -4.42 |
Secondary outcomeLeast squares mean· from baseline to 14 weeks, 26 weeks and 54 weeks
Percent Change in Body Weight Versus Active Comparator
| Group | Value (percentage) |
|---|---|
| Liraglutide | -3.40 |
| MEDI0382 100 mcg | -2.70 |
| MEDI0382 200 mcg | -3.47 |
| MEDI0382 300 mcg | -4.33 |
Secondary outcomeLeast squares mean· from baseline to 14 weeks, 26 weeks and 54 weeks
Absolute Change in Body Weight Versus Active Comparator
| Group | Value (kg) |
|---|---|
| Liraglutide | -3.25 |
| MEDI0382 100 mcg | -2.66 |
| MEDI0382 200 mcg | -3.45 |
| MEDI0382 300 mcg | -4.42 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboPlacebo / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 0 / 112 | 12 / 112 | 45 / 112 |
| LiraglutideLiraglutide + Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 0 / 110 | 8 / 110 | 36 / 110 |
| MEDI0382 100 mcgMEDI0382 low dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 0 / 100 | 12 / 100 | 51 / 100 |
| MEDI0382 200 mcgMEDI0382 mid dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 2 / 256 | 33 / 256 | 159 / 256 |
| MEDI0382 300 mcgMEDI0382 high dose / Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose) | 1 / 256 | 20 / 256 | 164 / 256 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2021
Corrected
Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study.
Nahra et al. 2021Diabetes carecited by 247
PMID 34016612PMC8247525DOI 10.2337/dc20-2151PUB-34016612
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 130 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Provision of informed consent
* Male and female subjects aged ≥ 18 years at screening
* Body mass index ≥ 25 kg/m2 at screening
* HbA1c range of 7.0% to 10.5% (inclusive) at screening
* Diagnosed with type-2 diabetes mellitus (T2DM) and treated with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 2 months prior to screening. Use of another glucose-lowering medication for up to 2 weeks in the 2 months prior to screening is acceptable
* Women of childbearing potential (WOCBP), not breastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product (IP), with a negative pregnancy test within 72 hours prior to the start of IP
Exclusion Criteria:
* History of, or any existing condition that, in the opinion of the Investigator, would interfere with evaluation of the IP, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures
* Any subject who has received another IP as part of a clinical study or a GLP-1 receptor agonist containing preparation within the last 30 days or 5 half lives of the drug (whichever is longer) at the time of screening
* Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
* Symptoms of acutely decompensated blood glucose control, a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily subcutaneous (SC) insulin for a period longer than 2 weeks within 90 days prior to screening
* Acute or chronic pancreatitis. Subjects with serum triglyceride concentrations above 1000 mg/dL (11 mmol/L) at screening
* Significant inflammatory bowel disease or other severe disease or surgery affecting the upper Gastrointestinal (GI) tract
* Significant hepatic disease
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤30 mL/minute/1.73m2 at screening
* Severely uncontrolled hypertension
* Unstable angina pectoris, myocardial infarction (MI), transient ischaemic attack (TIA), or stroke within 3 months prior to screening
* Severe congestive heart failure
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