A clinical trial to study the effect of antidiabetic drug Pioglitazone in patients with Type 2 Diabetes Mellitus when given as low dose or twice weekly dose
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/02/062959
- Lead Sponsor
- Dr Deepak Anand R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
HbA1C more than 7.0 %
FBS more than 126 mg/dl
RBS more than 200 mg/dl
Any duration of Diabetes Mellitus
On oral antidiabetics or naive to medications
BMI between 18 and 35 kg/cm
Exclusion Criteria
On insulin treatment or be
initiated during study period
Patients on pioglitazone or have received pioglitazone in the last one year
Past H/O Hematuria
Liver enzymes more than 2.5 ULN at
baseline
eGFR less than 60mg/dl
Concomitant CAD and/or Heart
Failure
Pedal edema of any cause
On Digoxin, Warfarin, Oral
Contraceptives
Females of childbearing potential
Pregnant females & Nursing
Mother
Presence of proliferative diabetic
retinopathy
Patients who have not given
consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decreased Insulin Resistance and Improved Glycemic ControlTimepoint: Baseline 4 weeks and 8 weeks
- Secondary Outcome Measures
Name Time Method Improved Lipid ProfileTimepoint: Baseline, 4 weeks and 12 weeks