A study to look at how safe, well tolerated, and what effect on the body, different doses of study drug MEDI0382 has in patients who are obese and overweight and have type 2 diabetes
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-002025-38-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
- 63
1. Male and female subjects aged = 18 years at screening
2. Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures
3. BMI between 27 and 40 kg/m2 (inclusive) at screening
4. HbA1c range of 6.5% to 8.5% (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 the 3 months prior to screening
6. Subjects prescribed oral dual therapy with a dipeptidyl peptidase-4 (DPPIV) inhibitor, sulphonylurea, glitinide, or a sodium-glucose co transporter 2 (SGLT-2) inhibitor in addition to metformin at screening may be eligible to enter the study following a 4-week washout period
7. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating
8. Females of childbearing potential who are sexually active with a nonsterilised male partner must use at least one highly effective method of contraception (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
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 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, 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
2. Any subject who has received another investigational product as part of a clinical study or a GLP-1 analogue-containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
3. Any subject who has received any of the following medications within the specified time frame prior to the start of the study (Visit 2) (see Section 4.7.2 for further details):
? Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion naltrexone, phentermine-topiramate, phentermine, lorcaserin)
? Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily
? Paracetamol (acetaminophen) or paracetamol containing preparations at a total daily dose of greater than 3g
? Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg
? Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying
4. Concurrent participation in another study of any kind and repeat randomisation in this study is prohibited
5. Severe allergy/hypersensitivity to any of the proposed study treatments,excipients, or ingredients of standardised meals
6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening
7. Significant inflammatory bowel disease, gastroparesis, 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
8. Significant hepatic disease (except for non-alcoholic steatohepatitis [NASH] or non alcoholic fatty liver disease [NAFLD]) without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
? Aspartate transaminase (AST) = 3 × upper limit of normal (ULN)
? Alanine transaminase (ALT) = 3 × ULN
? Total bilirubin = 2 × ULN
9. Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable [SI units])
10. Poorly controlled hypertension defined as:
? Systolic BP > 160 mm Hg
? Diastolic BP = 95 mm Hg
after 10 minutes of seated rest and confirmed by repeated measurement at screening. Subjects who fail BP screening criteria may be considered for 24-hour ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour systolic BP = 160 or diastolic BP < 95 mm Hg with a preserved nocturnal dip of > 15% will be considered eligible
11. Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening
12. Severe congestive heart failure (New York Heart Associati
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