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

Phase 1

Conditions: Type 2 diabetes mellitus (T2DM)
MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2017-000626-35-CZ

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 750

Inclusion Criteria

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
(levonorgestrelreleasing
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

Exclusion Criteria

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 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

Secondary Outcome Measures

Name	Time	Method

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