A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Intervention: MEDI0382 low dose; MEDI0382 mid dose; MEDI0382 high dose; Placebo; Liraglutide
Intervention description: Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
Masking: Triple (Participant, Care Provider, Investigator)
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.
Enrollment: 834.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

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
    

Eligibility 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