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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: MEDI0382 high dose; Drug: MEDI0382 mid dose; Drug: Placebo; Drug: MEDI0382 low dose; Drug: Liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235050

D5670C00004

Details and patient eligibility

About

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

Enrollment: 834 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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834 participants in 5 patient groups, including a placebo group

MEDI0382 low dose + Metformin

Experimental group

Description:

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

Treatment:

Drug: MEDI0382 low dose

MEDI0382 mid dose + Metformin

Experimental group

Description:

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

Treatment:

Drug: MEDI0382 mid dose

MEDI0382 high dose + Metformin

Experimental group

Description:

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

Treatment:

Drug: MEDI0382 high dose

Placebo + Metformin

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Liraglutide + Metformin

Active Comparator group

Description:

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

Treatment:

Drug: Liraglutide