A clinical trial to assess the effect of low dose pioglitazone in Type 2 Diabetes mellitus

Randomized, double-blind, clinical trial evaluating low-dose Pioglitazone on glycemic control and insulin resistance in Type-2 Diabetes mellitus: a non-inferiority trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/07/004716

Enrollment

Registered

2014-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes mellitus

Interventions

Intervention1: Pioglitazone 7.5 mg: Pioglitazone 7.5 mg orally daily for 3 months Control Intervention1: Pioglitazone 15 mg: Pioglitazone 15 mg orally dailly for 3 months Control Intervention2: Piogli

Eligibility

Inclusion criteria

Inclusion criteria: • Patients on optimal doses of sulfonylurea and /or metformin • Age between 25 years and 80 years • Either gender • FBS • HbA1c : 7 - 10 % • Patients willing to provide written informed consent

Exclusion criteria

Exclusion criteria: • Diabetes other than type 2 diabetes mellitus • Evidence of renal disease (S. creatinine > 1.5mg/ml) • Evidence of liver disease (AST/ALT >3 times normal) • H/o CCF or IHD • Pregnant and lactating mothers and women intending pregnancy • History of any hemoglobinopathy that may affect determination of Glycosylated Hemoglobin • History of intolerance or hypersensitivity to pioglitazone. • Participation in any other clinical trial with in the last 30 days

Design outcomes

Primary

Measure	Time frame
HbA1C levelsTimepoint: Baseline End of Third month of therapy	—

Secondary

Measure	Time frame
Adiponectin levelsTimepoint: Baseline End of Third month of therapy;BMITimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;Fasting Blood GlucoseTimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;HOMA-IRTimepoint: Baseline end of Third month of therapy;Leptin levelsTimepoint: Baseline End of Third month of therapy;Lipid profileTimepoint: Baseline End of Third month of therapy;Postprandial Blood GlucoseTimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;Serum Creatinine levelsTimepoint: Baseline End of Third month of therapy;SGOT and SGPT levelsTimepoint: Baseline End of Third month of therapy	—

Measure

Time frame

Adiponectin levelsTimepoint: Baseline End of Third month of therapy;BMITimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;Fasting Blood GlucoseTimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;HOMA-IRTimepoint: Baseline end of Third month of therapy;Leptin levelsTimepoint: Baseline End of Third month of therapy;Lipid profileTimepoint: Baseline End of Third month of therapy;Postprandial Blood GlucoseTimepoint: Baseline end of First month of therapy end of Second month of therapy end of Third month of therapy;Serum Creatinine levelsTimepoint: Baseline End of Third month of therapy;SGOT and SGPT levelsTimepoint: Baseline End of Third month of therapy

—

Countries

India

Contacts

Public ContactDr Amitava Chakrabarti

Post Graduate Institute of Medical Education and Research

amitavachakrabarti315@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026