Comparison of old anti-diabetic drugs Pioglitazone and Glimepiride in Indian patients, which one is better in terms of improvement of underlying cause of disease.

Effect of Pioglitazone vs Glimepiride on body composition and other parameters of adiposopathy in non-obese Asian Indian diabetics: A randomized open labeled parallel group comparative single centre study - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057166

Enrollment

142

Registered

2023-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: TABLET PIOGLITAZONE: Study group (Pioglitazone Group): T2DM patients receiving medical nutrition therapy and metformin and have uncontrolled blood glucose target (FBG 130 mg/dl, 2 hours

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed type-2 Diabetes Mellitus (ADA criteria) with BMI 18yrs 2. Type 2 diabetic patients with uncontrolled blood sugar (FBS >130, PPBS >180) on life-style intervention plus maximally tolerated dose of metformin

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Patients with secondary Diabetes. 2. Patients with Type 1 Diabetes Mellitus. 3. Patients with latent autoimmune diabetes of adult. 4. Patient on insulin 5. Contraindication to pioglitazone (Active liver disease, NYHA Class 3 and 4 chf, CSME, hypersensitivity), metformin (severe renal impairment; egfr < 30mL/min/1.73m2, known hypersensitivity, acute or chronic metabolic acidosis including DKA) or glimepiride (known hypersensitivity, DKA, G6PD deficiency) 6. Pregnancy and lactation 7. Who refused for consent.

Design outcomes

Primary

Measure	Time frame
a) Insulin Resistance b) Beta cell function: Homa-B & C-peptide c) Beta cell mass- C-peptide/ blood glucose d) Whole body fat mass by DXA scan e) Ectopic fat by MRI f) Leptin, adiponectin, adipogenesis markers, TNF alpha , IL-6 g) Molecular markers of micro RNA: 8 circulating micro RNAs (hsa-mir-133B, hsa-mir-210, hsa-mir-22, hsa-mir-25, hsa-mir-27A, hsa-mir-27B, hsa-mir-30E, hsa-mir-503)Timepoint: baseline to 6 months after intervention	—

Measure

Time frame

a) Insulin Resistance b) Beta cell function: Homa-B & C-peptide c) Beta cell mass- C-peptide/ blood glucose d) Whole body fat mass by DXA scan e) Ectopic fat by MRI f) Leptin, adiponectin, adipogenesis markers, TNF alpha , IL-6 g) Molecular markers of micro RNA: 8 circulating micro RNAs (hsa-mir-133B, hsa-mir-210, hsa-mir-22, hsa-mir-25, hsa-mir-27A, hsa-mir-27B, hsa-mir-30E, hsa-mir-503)Timepoint: baseline to 6 months after intervention

—

Secondary

Measure	Time frame
In a small number of selected patients adipocyte size, macrophage infiltration cell type & transcriptome profile in pathways of adipogenesis will be determinedTimepoint: baseline to 6 months after intervention	—

Countries

India

Contacts

Public ContactKashish Gupta

SMS medical college and hospital Jaipur

drsandeepmathur@rediffmail.com9414048666

Outcome results

None listed

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