Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects

Plain-language summary

This study investigates the effectiveness of the drugs Pioglitazone hydrochloride and Metformin hydrochloride in Bangladeshi people with type 2 diabetes mellitus, and the relationship between response to pioglitazone and variants in the PPARG gene. It enrolled patients aged 40-50 treated with pioglitazone or metformin alone. The study was carried out in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

University of Dhaka

Intervention

Pioglitazone hydrochloride, Metformin hydrochloride

Start date

11/1/2008

Estimated completion

6/1/2010

Countries

Bangladesh

Related genes

Locations

• Dhaka, Bangladesh

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Type 2 DM patients (with HbA1c level \< 8.5 %, BMI kg/m2 ≥ 25, SGPT ≤ 100 IU/L , creatinine ≤ 1.2 mg/dl) of both sexes,
* Aged between 40-50,
* Treated by monotherapy of pioglitazone or metformin.

Exclusion Criteria:

* Patients with diabetes secondary to another cause.
* Patients suffering from serious incurrent illness requiring systemic treatment.
* Patients suffering from any other infectious diseases.
* Patients with impaired kidney function (serum creatinine level more than 1.2mg/dl)
* Patients with impaired hepatic function (SGPT ≥ 100 IU/L).
* Patients with pulmonary insufficiency with hypoxaemia.
* Triglyceriadiamea (TG ≥ 150mg/dl).
* Bloodpressure \> 180 mmHg (Systolic) or \> 110 mmHg (diastolic).
* Positive history of drug or alcohol abuse.
* Pregnant women and willing to be pregnant shortly.