A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

July 31, 2020 updated by: AstraZeneca

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

834

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Botevgrad, Bulgaria, 2140
        • Research Site
      • Kozloduy, Bulgaria
        • Research Site
      • Kyustendil, Bulgaria, 2500
        • Research Site
      • Lukovit, Bulgaria
        • Research Site
      • Petrich, Bulgaria, 2850
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Russe, Bulgaria, 7002
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Sofia, Bulgaria, 1618
        • Research Site
      • Sofia, Bulgaria, 1223
        • Research Site
      • Stara Zagora, Bulgaria, 6000
        • Research Site
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • Research Site
      • Sherwood Park, Alberta, Canada, T8L 0N2
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • Research Site
      • Etobicoke, Ontario, Canada, M9W 4L6
        • Research Site
      • Guelph, Ontario, Canada, N1H 1B1
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • London, Ontario, Canada, N6G 5A9
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • Research Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Research Site
    • Quebec
      • Levis, Quebec, Canada, G6W 0M5
        • Research Site
      • Montreal, Quebec, Canada, H4A 3T2
        • Research Site
      • Montreal, Quebec, Canada, H4N 2W2
        • Research Site
      • Saint-Marc-des-Carrieres, Quebec, Canada, G0A 4B0
        • Research Site
  • Czechia
      • Beroun, Czechia, 266 00
        • Research Site
      • Jilove u Prahy, Czechia, 254 01
        • Research Site
      • Pardubice, Czechia, 530 02
        • Research Site
      • Plzen, Czechia, 301 66
        • Research Site
      • Plzen - Severni Predmesti, Czechia, 301 00
        • Research Site
      • Praha, Czechia, 140 59
        • Research Site
      • Praha - Klanovice, Czechia, 190 14
        • Research Site
      • Praha 10, Czechia, 104 00
        • Research Site
      • Praha 4, Czechia, 140 00
        • Research Site
      • Praha 4, Czechia, 149 00
        • Research Site
      • Uherske Hradiste, Czechia, 686 01
        • Research Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Research Site
      • Berlin, Germany, 10787
        • Research Site
      • Berlin, Germany, 10437
        • Research Site
      • Eschweiler, Germany, 52249
        • Research Site
      • Essen, Germany, 45136
        • Research Site
      • Essen, Germany, 45359
        • Research Site
      • Gelnhausen, Germany, 63571
        • Research Site
      • Hamburg, Germany, 21109
        • Research Site
      • Hamburg, Germany, 22607
        • Research Site
      • Hof, Germany, 95030
        • Research Site
      • Löhne, Germany, 32584
        • Research Site
      • Lübeck, Germany, 23538
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Mannheim, Germany, 68163
        • Research Site
      • Munster, Germany, 48145
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Pirna, Germany, 01796
        • Research Site
      • Rhaunen, Germany, 55624
        • Research Site
      • Villingen-Schwenningen, Germany, 78048
        • Research Site
  • Mexico
      • Guadalajara, Mexico, 44670
        • Research Site
      • Monterrey, Mexico, 66465
        • Research Site
      • México, Mexico, 11650
        • Research Site
      • México, Mexico, 03300
        • Research Site
      • Veracruz, Mexico, 91900
        • Research Site
      • Veracruz, Mexico, 91910
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454091
        • Research Site
      • Ekaterinburg, Russian Federation, 620039
        • Research Site
      • Izhevsk, Russian Federation, 426035
        • Research Site
      • Kemerovo, Russian Federation, 650066
        • Research Site
      • Moscow, Russian Federation, 125367
        • Research Site
      • Moscow, Russian Federation, 119435
        • Research Site
      • Moscow, Russian Federation, 119034
        • Research Site
      • Novosibirsk, Russian Federation, 630051
        • Research Site
      • Perm, Russian Federation, 614000
        • Research Site
      • Perm, Russian Federation, 614068
        • Research Site
      • Saint Petersburg, Russian Federation, 196601
        • Research Site
      • Saint-Petersburg, Russian Federation, 199226
        • Research Site
      • St. Petersburg, Russian Federation, 196084
        • Research Site
      • St.Petersburg, Russian Federation, 198013
        • Research Site
      • Vladikavkaz, Russian Federation, 362007
        • Research Site
      • Volgograd, Russian Federation, 400131
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Research Site
      • Bratislava, Slovakia, 831 01
        • Research Site
      • Dolny Kubin, Slovakia, 026 01
        • Research Site
      • Levice, Slovakia, 934 01
        • Research Site
      • Lucenec, Slovakia, 984 01
        • Research Site
      • Malacky, Slovakia, 901 01
        • Research Site
      • Namestovo, Slovakia, 029 01
        • Research Site
      • Nitra, Slovakia, 949 11
        • Research Site
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • Research Site
      • Prievidza, Slovakia, 971 01
        • Research Site
      • Rimavska Sobota, Slovakia, 979 01
        • Research Site
      • Roznava, Slovakia, 048 01
        • Research Site
      • Sabinov, Slovakia, 083 01
        • Research Site
      • Trebisov, Slovakia, 075 01
        • Research Site
      • Trencin, Slovakia, 911 01
        • Research Site
      • Trnava, Slovakia, 917 01
        • Research Site
      • Zilina, Slovakia, 010 01
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Glendale, Arizona, United States, 85308
        • Research Site
      • Glendale, Arizona, United States, 85306
        • Research Site
      • Mesa, Arizona, United States, 85213
        • Research Site
    • Georgia
      • Marietta, Georgia, United States, 30067
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Research Site
      • Metairie, Louisiana, United States, 70006
        • Research Site
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Research Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Research Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
    • Texas
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77040
        • Research Site
      • Plano, Texas, United States, 75093
        • Research Site
    • Utah
      • Layton, Utah, United States, 84014
        • Research Site
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Research Site
      • Manassas, Virginia, United States, 20110
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: MEDI0382 low dose
Pharmaceutical form: solution Route of administration: subcutaneous
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)
Drug: MEDI0382 mid dose
Pharmaceutical form: solution Route of administration: subcutaneous
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)
Drug: MEDI0382 high dose
Pharmaceutical form: solution Route of administration: subcutaneous
PLACEBO_COMPARATOR: Placebo + Metformin
Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: Placebo
Pharmaceutical form: solution Route of administration: subcutaneous
ACTIVE_COMPARATOR: Liraglutide + Metformin
Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
Drug: Liraglutide
Pharmaceutical form: solution Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 14 weeks
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
From baseline to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to 26 weeks and 54 weeks
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
after 14, 26, and 54 weeks
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
from baseline to 26 weeks and 54 weeks
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
from baseline to 14 weeks, 26 weeks and 54 weeks
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
from baseline to 14 weeks, 26 weeks and 54 weeks
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
from baseline to 14 weeks, 26 weeks and 54 weeks
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
after 14 weeks, 26 weeks and 54 weeks
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
at 14 weeks, 26 weeks and 54 weeks
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
Time points at which outcome measure were assessed for plasma concentration were Weeks 1,2,6,10,14,18,22,26, and 54
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
Baseline through 54-week treatment period and 28-day follow-up
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
To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide
Baseline through 54-week treatment period and 28-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2017

Primary Completion (ACTUAL)

May 3, 2018

Study Completion (ACTUAL)

June 14, 2019

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 27, 2017

First Posted (ACTUAL)

August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5670C00004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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