DRUG
MEDI0382 low dose
Pharmaceutical form: solution Route of administration: subcutaneous
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
Status
Completed
Phase
Phase 2
Enrollment
834
Locations
119
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
MEDI0382 mid dose
Pharmaceutical form: solution Route of administration: subcutaneous
DRUG
MEDI0382 high dose
Pharmaceutical form: solution Route of administration: subcutaneous
DRUG
Placebo
Pharmaceutical form: solution Route of administration: subcutaneous
DRUG
Liraglutide
Pharmaceutical form: solution Route of administration: subcutaneous
Timeline
From registration to results.
First posted
Aug 1, 2017
Study start
Aug 2, 2017
Primary completion
May 3, 2018
Study completion
Jun 14, 2019
Results posted
Jul 20, 2020
Registry updated
Aug 17, 2020
Outcomes
What the study measures.
Primary outcomes
Change in HbA1c
Time frame · From baseline to 14 weeks
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
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
Secondary outcomes
Change in HbA1c
Time frame · from baseline to 26 weeks and 54 weeks
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
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
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
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
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
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
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
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
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
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 130 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
119 registered sites.
Bulgaria · Canada · Czechia · Germany · Mexico · Russia · Slovakia · United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Birmingham, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Glendale, Arizona, United States
Research Site
Glendale, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Marietta, Georgia, United States
Research Site
Evansville, Indiana, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Metairie, Louisiana, United States
Research Site
Elkridge, Maryland, United States
Research Site
Bridgeton, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brooklyn, New York, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greer, South Carolina, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Layton, Utah, United States
Research Site
Arlington, Virginia, United States
Research Site
Manassas, Virginia, United States
Research Site
Botevgrad, Bulgaria
Research Site
Kozloduy, Bulgaria
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A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
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A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants
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A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus
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