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

Summary

* The present study was undertaken to assess the efficacy and safety of two different insulin sensitizers (namely Pioglitazone and Metformin) among subjects with type 2 diabetes mellitus (T2DM) in Bangladesh.
* A prospective, double-blind, single group, 'within-subject' designed clinical trial of 77 diagnosed T2DM patients out of 130 patients with glycosylated haemoglobin (HbA1c) ≥7.2±1.5%, aged 46±6.4 years and registered for diabetes treatment in Bangladesh Institute of Research and Rehabilitation in Diabetes Endocrine and Metabolic Disorders (BIRDEM) was carried out.
* The study was conducted between November 2008 and September 2010.
* Baseline data, included case history of the patients,anthropometric measurement, biomedical parameters psychosocial factors, were collected from each subject and then enrolled to receive treatment with 001 drug once daily for three months, then the patients were left for wash out with metformin 850mg once daily for one month; then they received 002 drug once daily for further three months.
* Dietary chart was remained as before.
* DNA was isolated by Chelex method using the primers and control DNA,restriction Digestion Enzyme Endonuclease Hae 111 for genotyping PPARγ-(Peroxisome Proliferator Activated Receptor gamma)Pro12Pro

* (Proline12Proline)/Pro12Ala-(Proline12 Alanine))/Ala12Ala-(Alanine12Alanine).
* The blinded drugs were decoded after analyzing results, 001 tablet was pioglitazone (30 mg once daily) and 002 tablets was metformin (850mg once daily). Bio-medical outcomes were measured to assess the efficacy of both the drugs each month. After finishing the treatment period the effects of two drugs were compared using SPSS.And the association between the pioglitazone drug effects and genetic polymorphism was also assessed.
* The metformin effects was assessed also using the response rate of HbA1c \<7.0% after 3 months treatment to the patients.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Pioglitazone hydrochloride

77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.

DRUG

Metformin hydrochloride

After the treatment with pioglitazone(001) for 3 months first and then patients were on one month washout period;in the washout period they were given metformin tablet 850mg once daily,then treated with 002 (metformin) for further 3 months. The same biomedical measurements were assayed.

Sponsors & Collaborators

• Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders

  collaborator OTHER

• University of Dundee

  collaborator OTHER

• University of Dhaka

  lead OTHER

Principal Investigators

• AK Azad Chowdhury, PhD · University of Dhaka, Bangladesh

• Masuma Parvin, PhD · University of Dhaka, Bangladesh

• Begum Rokeya, PhD · BIRDEM,Dhaka,Bangladesh

• Colin Palmer, PhD · University of Dundee

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2009-12-31

Completion

2010-06-30

Countries

• Bangladesh

Study Locations