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
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Pioglitazone hydrochloride; Metformin hydrochloride
Intervention description: 77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.; 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.
Intervention MeSH terms: Metformin; Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 40 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Bangladesh; T2DM; Pioglitazone; Metformin; Insulin secretion and Sensitivity

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.
    

Eligibility 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.