NCT01589445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 27, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

April 29, 2012

Results QC Date

May 5, 2012

Last Update Submit

February 26, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

BangladeshT2DMPioglitazoneMetforminInsulin secretion and Sensitivity

Outcome Measures

Primary Outcomes (5)

  • Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin

    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.

    3 months for each drug

  • Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin

    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.

    3 months for each drug

  • Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin

    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)

    3 months for each drug

  • Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin

    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)

    3 months for each drug

  • Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin

    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.

    3 months for each drug

Secondary Outcomes (1)

  • Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin

    3 months for each drug

Study Arms (2)

Pioglitazone (001 group)

EXPERIMENTAL

The patients received pioglitazone hydrochloride tablet 30 mg (001 drug)once daily for first three months

Drug: Pioglitazone hydrochlorideDrug: Metformin hydrochloride

Metformin (002 group)

EXPERIMENTAL

The patients received metformin hydrochloride tablet 850 mg (002 drug)once daily for next three months.

Drug: Pioglitazone hydrochlorideDrug: Metformin hydrochloride

Interventions

Pioglitazone hydrochlorideDRUG

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

Also known as: GLUCOZON, 30 mg tablet, once, daily, Coded as B001(Preparation Date:Jun 08), Aristopharma LTD.,Bangladesh
Metformin (002 group)Pioglitazone (001 group)
Metformin hydrochlorideDRUG

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.

Also known as: GLUCOMET, 850 mg tablet, once, daily, Coded as B002 (Preparation date: Jun 08), Aristopharma LTD.,Bangladesh
Metformin (002 group)Pioglitazone (001 group)

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM)

Dhaka, Dhaka Division, 1000, Bangladesh

Location

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Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypersensitivity

Interventions

PioglitazoneTabletsMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsBiguanidesGuanidinesAmidines

Limitations and Caveats

The sample size was relatively small for more detailed analysis, treatment period was also short and there was a possibility of confounding by the use of non-study medication.

Results Point of Contact

Title
Dr. Masuma Parvin
Organization
Ministry of Science and Technology, Government of the People's Republic of Bangladesh
acmasuma@gmail.com
88 01819141258

Study Officials

  • AK Azad Chowdhury, PhD

    University of Dhaka, Bangladesh

    STUDY CHAIR

  • Masuma Parvin, PhD

    University of Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

  • Begum Rokeya, PhD

    BIRDEM,Dhaka,Bangladesh

    STUDY DIRECTOR

  • Colin Palmer, PhD

    University of Dundee

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

April 29, 2012

First Posted

May 2, 2012

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

February 28, 2014

Results First Posted

February 27, 2014

Record last verified: 2014-02

Locations

BA(1)