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 (T2DMCT)
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Purpose
The present study was undertaken to assess the effect of pioglitazone [a peroxisome proliferator-activated receptor gamma (PPARγ) agonist] in Bangladeshi T2DM subjects on insulin secretion and insulin resistance and the influence of PPARγ gene variants on the response rate to pioglitazone therapy in the same population. Metformin, another insulin sensitizer, was also given to the patients after 3 months treatment with 15 days washout period in a parallel design for further 3 months..
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Generic Name: Pioglitazone, Metformin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Modulation of Insulin Secretion and Insulin Sensitivity in Bangladeshi Type 2 Diabetic Subjects by an Insulin Sensitizer Pioglitazone and T2DM Association With PPARG Gene Polymorphism. |
- Glycemic status [ Time Frame: 3 months for each drug ] [ Designated as safety issue: No ]
Glycemic (FSG,2hrSG,HbA1c) and Insulinemic (FSI, 30min SI, 90min SI, 2hrSI) status of the patients to understand Insulin secretion and Insulin sensitivity after treatment with Pioglitazone or Metformin.
Association with the PPAR-γ gene Polymorphism and Pioglitazone response in T2DM patients.
- Lipidic status [ Time Frame: 3 months for each drug ] [ Designated as safety issue: No ]Effect of Pioglitazone or Metformin on Lipidemic status (Total Cholesterol, HDL,LDL), BMI and on SGPT and Creatinine after 3 months treatment
| Enrollment: | 77 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pioglitazone |
Drug: Generic Name: Pioglitazone, Metformin
77 patients were treated with pioglitazone for 3 months first and then the patients were treated with metformin for further 3 months after 1 month washout period. Dosage form-Tablet Dosage- Pioglitazone 30mg/day Metformin-850mg/day Frequency- 1 for both of the drugs Duration- 3 months for each drug Arms/groups- For two interventions was assigned for one group. |
| Experimental: Metformin |
Drug: Generic Name: Pioglitazone, Metformin
77 patients were treated with pioglitazone for 3 months first and then the patients were treated with metformin for further 3 months after 1 month washout period. Dosage form-Tablet Dosage- Pioglitazone 30mg/day Metformin-850mg/day Frequency- 1 for both of the drugs Duration- 3 months for each drug Arms/groups- For two interventions was assigned for one group. |
Detailed Description:
Both β cell dysfunction and insulin resistance are core defects in the progression of T2DM and their relative contribution vary among different ethnic population due to heterogeneous nature of the diseases. The trial was carried out on 80 Type 2 Diabetic subjects who were selected according to inclusion and exclusion criteria. The patients were randomized to receive treatment with pioglitazone 30mg per day for 3 months followed by 2 week wash-out period, then forwarded to the alternative treatment regimen with metformin 850 mg per day for further 3 months. Outcome measures included glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG) and 2 hours blood glucose (2hBG), insulin levels (FSI), total cholesterol (TC), high and low density lipoprotein cholesterol (HDL-C and LDL-C respectively), triglycerides (TG), BMI, SGPT and serum creatinine. Insulin secretory capacity (HOMA%B), Insulin sensitivity (HOMA%S),and insulin resistance (HOMA IR) were calculated by HOMA sigma software. Insulin sensitivity was also calculated by QUICKI. For the genetic analysis extracted DNA from blood was amplified by PCR and then digested with HaeIII restriction enzyme and visualized the banding pattern to distinguish among the alleles. Data were analyzed by SPSS version 18 (using univariate and multivariate tools).
Eligibility| Ages Eligible for Study: | 40 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Bangladesh | |
| Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) | |
| Dhaka, Bangladesh, 1000 | |
| Principal Investigator: | AK Azad Chowdhury, PhD | University of Dhaka |
More Information
No publications provided
| Responsible Party: | Dr.AK Azad Chowdhury, Professor, University of Dhaka |
| ClinicalTrials.gov Identifier: | NCT01589445 History of Changes |
| Other Study ID Numbers: | BS-67/2008-09, BMRC/ERC/2007-2010/2024 |
| Study First Received: | April 29, 2012 |
| Last Updated: | May 1, 2012 |
| Health Authority: | Bangladesh: Bangladesh Medical Research Council |
Keywords provided by University of Dhaka:
|
Bangladesh T2DM Pioglitazone Metformin Insulin secretion and Sensitivity |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013