EUCTR2006-001982-41-GB
Active, not recruiting
Phase 1
An evaluation of the safety and effectiveness of combination therapy using the thiazolidinedione pioglitazone alongside insulin in type 2 diabetes mellitus.
DrugsActos
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Consent withheld or withdrawn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
Outcomes
Primary Outcomes
Not specified
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