A Phase 1 and 2 study of multiple increasing doses to evaluate the ability of MEDI0382 to produce the intended result and the safety of effects of MEDI0382 in overweight and obese subjects with Type 2 Diabetes.

Phase 1

Conditions: Type 2 Diabetes in Overweight and Obese Patients
MedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-003716-36-DE

Lead Sponsor: MedImmune Limited, a wholly owned subsidiary of AstraZeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 107

Inclusion Criteria

-Male or female age 18-65
-Must provide written informed consent
-Body mass index 27 to 40 kg/m2
-Vital signs within normal specified ranges
-Diagnosis of T2DM and glucose control managed with metformin monotherapy where no significant dose change has occurred in the 3 months prior to screening.
-Venous access suitable for multiple cannulations.
-For subjects in Cohort 4, 5 and 6: Willing and able to self-administer daily SC injections.
-Females must be non-lactating and non-childbearing potential
-Males must practice 2 effective contraceptive measures if sexually active

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

-Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
-History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
-History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
-History or presence of diabetic foot ulcers
-Any clinically important illness (apart from T2DM for subjects with known diabetes), medical/ surgical procedure, or trauma within 4 weeks prior to Day 1 dosing.
-Symptoms of insulinopenia or poor blood glucose control
- Fasting blood glucose = 200 mg/dL
-Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
-Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
-Known or suspected history of alcohol or drug abuse within the past 3 years. Positive drug screen.