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Clinical Trials/EUCTR2006-001982-41-GB
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.

Bradford Teaching Hospitals NHS Foundation Trust0 sites40 target enrollmentSeptember 29, 2006
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.

Registry
who.int
Start Date
September 29, 2006
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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  • Consent withheld or withdrawn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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