An evaluation of the safety and effectiveness of combination therapy using the thiazolidinedione pioglitazone alongside insulin in type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
- Registration Number
- EUCTR2006-001982-41-GB
- Lead Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Type 2 diabetes treated with insulin +/- metformin +/- sulphonylurea
Insulin resistant (requiring >0.8U/kg/day insulin) and/or acanthosis nigricans present
BMI >28kg m-2
HbA1c >7.0%
Aged 16 and over
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Consent withheld or withdrawn
Unable to comply with the treatment schedule (as judged by investigator)
Current active heart failure (NYHA grade III– IV; see appendix 2 for definition)
History of hospital admission with heart failure in the last 12 months (from medical records)
Anaemia at baseline (Hb < 11mg/dl)
Abnormal liver biochemistry at baseline, defined as ALT >100IU/l (approx. 2.5x upper limit of normal)
Previous adverse reaction to TZD (any previous exposure with reported adverse effect)
Women of childbearing potential planning pregnancy or not using contraception
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