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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MEDI0382 low dose

MEDI0382 mid dose

MEDI0382 high dose

Placebo

Liraglutide

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

MEDI0382 low dose + Metformin

MEDI0382 mid dose + Metformin

MEDI0382 high dose + Metformin

Placebo + Metformin

Liraglutide + Metformin

Arm Description

Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Outcomes

Primary Outcome Measures

Change in HbA1c

To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo

Percent Change in Body Weight

To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo

Secondary Outcome Measures

Change in HbA1c

To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo

Percentage of Participants Achieving an HbA1c Target < 7.0%

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

To assess the effect of 100, 200, and 300 μg of cotadutide on body weight versus placebo

Absolute Change in Body Weight

To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo

Percent Change in Body Weight Versus Active Comparator

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

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%

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

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)

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)

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

To characterise the immunogenicity of 100, 200, and 300 μg of cotadutide

Full Information

NCT ID

NCT03235050

First Posted

July 21, 2017

Last Updated

July 31, 2020

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT03235050

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

August 2, 2017 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

MedImmune LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The study will be conducted in a double-blind fashion for MEDI0382 and placebo. The sponsor staff, the subjects, and the Investigators involved in the treatment of subjects or in the clinical evaluation of subjects will not be aware of the treatment received. Liraglutide will be provided in an open-label active comparator arm.

Allocation

Randomized

Enrollment

834 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEDI0382 low dose + Metformin

Arm Type

Experimental

Arm Description

Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Arm Title

MEDI0382 mid dose + Metformin

Arm Type

Experimental

Arm Description

Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Arm Title

MEDI0382 high dose + Metformin

Arm Type

Experimental

Arm Description

Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Arm Title

Placebo + Metformin

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Arm Title

Liraglutide + Metformin

Arm Type

Active Comparator

Arm Description

Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Intervention Type

Drug

Intervention Name(s)

MEDI0382 low dose

Intervention Description