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

Study identifier:D5670C00004

ClinicalTrials.gov identifier:NCT03235050

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 2

Healthy volunteers

Study drug

MEDI0382 low dose, MEDI0382 mid dose, MEDI0382 high dose, Placebo, Liraglutide

Sex

All

Actual Enrollment

834

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 02 Aug 2017

Primary Completion Date: 03 May 2018

Study Completion Date: 14 Jun 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2020 by AstraZeneca

Collaborators

MedImmune, LLC

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions
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

Documents available

D5670C00004 SAP redacted
Download
D5670C00004 CSP redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]