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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
834

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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