An evaluation of the safety and effectiveness of combination therapy using the thiazolidinedione pioglitazone alongside insulin in type 2 diabetes mellitus.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001982-41-GB

Enrollment

Registered

2006-09-29

Start date

2006-10-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus MedDRA version: 8.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: Actos Product Name: Actos Tablets Pharmaceutical Form: Tablet INN or Proposed INN: PIOGLITAZONE HYDROCHLORIDE CAS Number: 11

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Consent withheld or withdrawn Unable to comply with the treatment schedule (as judged by investigator) Current active heart failure (NYHA grade III– IV; see appendix 2 for definition)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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Can pioglitazone and insulin be used safely in combination, is the combination effective, and how can we best measure the safety of this treatment? ;Secondary Objective: Are there any beneficial effects of the combination treatment in areas other than blood glucose control, eg. weight, lipids.; Primary end point(s): 1. Change in nt-pro-BNP concentration from baseline 2. Admission to hospital or change in treatment for a confirmed diagnosis of heart failure	—

Measure

Time frame

Main Objective: Can pioglitazone and insulin be used safely in combination, is the combination effective, and how can we best measure the safety of this treatment? ;Secondary Objective: Are there any beneficial effects of the combination treatment in areas other than blood glucose control, eg. weight, lipids.; Primary end point(s): 1. Change in nt-pro-BNP concentration from baseline 2. Admission to hospital or change in treatment for a confirmed diagnosis of heart failure

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026