Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been completed.
Sponsor:
Collaborators:
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
University of Dundee
Information provided by (Responsible Party):
Dr. Masuma Parvin, University of Dhaka
ClinicalTrials.gov Identifier:
NCT01589445
First received: April 29, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose
  • 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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Pioglitazone hydrochloride
Drug: Metformin hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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.

Resource links provided by NLM:


Further study details as provided by University of Dhaka:

Primary Outcome Measures:
  • Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]
    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

  • Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]
    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

  • Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]

    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

    Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)


  • Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]

    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

    Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)


  • Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]
    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.


Secondary Outcome Measures:
  • Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin [ Time Frame: 3 months for each drug ] [ Designated as safety issue: Yes ]

    Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.

    Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)



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 (001 group)
The patients received pioglitazone hydrochloride tablet 30 mg (001 drug)once daily for first three months
Drug: Pioglitazone hydrochloride
77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.
Other Names:
  • GLUCOZON
  • 30 mg tablet, once, daily
  • Coded as B001(Preparation Date:Jun 08)
  • Aristopharma LTD.,Bangladesh
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.
Other Names:
  • GLUCOMET
  • 850 mg tablet, once, daily
  • Coded as B002 (Preparation date: Jun 08)
  • Aristopharma LTD.,Bangladesh
Experimental: Metformin (002 group)
The patients received metformin hydrochloride tablet 850 mg (002 drug)once daily for next three months.
Drug: Pioglitazone hydrochloride
77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.
Other Names:
  • GLUCOZON
  • 30 mg tablet, once, daily
  • Coded as B001(Preparation Date:Jun 08)
  • Aristopharma LTD.,Bangladesh
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.
Other Names:
  • GLUCOMET
  • 850 mg tablet, once, daily
  • Coded as B002 (Preparation date: Jun 08)
  • Aristopharma LTD.,Bangladesh

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589445

Locations
Bangladesh
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM)
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
University of Dhaka
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
University of Dundee
Investigators
Study Chair: AK Azad Chowdhury, PhD University of Dhaka, Bangladesh
Principal Investigator: Masuma Parvin, PhD University of Dhaka, Bangladesh
Study Director: Begum Rokeya, PhD BIRDEM,Dhaka,Bangladesh
Study Director: Colin Palmer, PhD University of Dundee, UK
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Masuma Parvin, Research fellow, 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
Results First Received: May 5, 2012
Last Updated: February 26, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014