A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects with Type 2 Diabetes
- Conditions
- Type 2 diabetes mellitus (T2DM)MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2017-000626-35-BG
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 834
For inclusion in the study, subjects should fulfil the following criteria:
1. Provision of informed consent prior to any study-specific procedures
2. Male and female subjects aged = 18 years at screening
3. Body mass index =25 kg/m2 at screening
4. HbA1c range of 7.0% to 10.5% (inclusive) at screening
5. Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease =500 mg/day) has occurred in at least the 2 months prior to screening and the total daily dose of metformin is =1500 mg unless metformin is only tolerated at a lower dose. Use of another glucose-lowering medication for up to 2-weeks in the 2 months prior to screening is acceptable (a GLP-1 receptor agonist containing preparation cannot be used within the last 30 days or 5 half-lives of the drug, whichever is longer, at the time of screening)
6. For women of childbearing potential:
- Must be using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of IP. Appropriate birth control is defined as a method which results in a low failure rate, ie, less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives [pills, vaginal rings, or patches], some intrauterine contraceptive devices (levonorgestrel-releasing or copper-T), tubal ligation or occlusion, total sexual abstinence that is in line with the preferred and usual lifestyle choice of the subject, or a vasectomized partner during the entire duration of the study. As applicable, at least one method must be in effect prior to receiving the first dose of IP
- Must have a negative serum or urine pregnancy test within 72 hours prior to the start of IP
- Must not be breastfeeding
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
Main 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 during the run-in period
* 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 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 as this can precipitate acute pancreatitis
* Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data
* 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 (New York Heart Association Class IV)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of 100 µg, 200 µg and 300 µg of MEDI0382 on haemoglobin A1c (HbA1c) and body weight versus placebo;Secondary Objective: To assess the effect of 100 µg, 200 µg and 300 µg of MEDI0382 on additional measures of glycaemic control and body weight versus placebo<br><br>To assess the effect of 100 µg, 200 µg and 300 µg of MEDI0382 on the requirement for additional blood glucose lowering therapies versus placebo <br><br>To assess the effect of 100 µg, 200 µg and 300 µg of MEDI0382 on weight versus liraglutide 1.8 mg once daily <br><br>To characterise the pharmacokinetic (PK) profile and immunogenicity of 100 µg, 200 µg and 300 µg of MEDI0382;Primary end point(s): Change in HbA1c and percent change in body weight from baseline;Timepoint(s) of evaluation of this end point: Week 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in HbA1c from baseline <br>2. Percentage of subjects achieving an HbA1c target of <7.0% <br>3. Percent and absolute change in body weight from baseline <br>4. Percentage of subjects achieving weight loss of =5% and =10%;Timepoint(s) of evaluation of this end point: Week 26, week 54 (1.)<br>Week 14, week 26, week 54 (2.,3.,4.)