Phase 4
Completed N=77
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
Source: ClinicalTrials.gov NCT01589445 ↗Enrolled (actual)
77
Serious AEs
1.4%
Results posted
Feb 2014
Primary outcomePrimary: Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin — 6.9; 6.2; 5.4; 6.5 mmol/l — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin |
6.9; 6.2; 5.4; 6.5 | <0.05 sig |
| PRIMARY Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin |
7.3; 7.8; 6.7; 7.0 | >0.05 |
| PRIMARY Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin |
0.52; 0.57; 0.59; 0.54; 5.1; 3.7 | <0.001 sig |
| PRIMARY Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin |
118.9; 109.3; 132.3; 116.0; 51.1; 76.2 | <0.808 |
| PRIMARY Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin |
16.2; 13.0; 12.3; 13.9 | <0.039 sig |
| SECONDARY Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin |
182.0; 193.0; 178; 177.0; 183; 166.0 | <0.161 |
Eligibility Criteria
Inclusion Criteria
- Type 2 DM patients (with HbA1c level 180 mmHg (Systolic) or > 110 mmHg (diastolic).
- Positive history of drug or alcohol abuse.
- Pregnant women and willing to be pregnant shortly.
Data sourced from ClinicalTrials.gov (NCT01589445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.