A Comparative Study of Lobeglitazone Versus Pioglitazone on Urine Albumin to Creatinine Ratio (UACR) In Normotensive and Hypertensive Type 2 Diabetes Mellitus Patients

A Comparative Study of Lobeglitazone Versus Pioglitazone on Urinary Albumin to Creatinine Ratio (UACR) In Normotensive and Hypertensive Type 2 Diabetes Mellitus Patients - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078217

Enrollment

200

Registered

2024-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Lobeglitazone: Tab Lobeglitazone 0.5 mg once daily for 6 months Control Intervention1: Pioglitazone: Tab Pioglitazone 15 mg once daily for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1) T2DM patients of either gender between age group 18 to 60 years. 2) HBA1c between 6.5 to 8.5. 3) T2DM patients taking other oral antidiabetic drugs excluding the study drugs Lobeglitazone and Pioglitazone. 4) T2DM normotensive patients. 5) T2DM hypertensive patients taking either ACE inhibitors or ARBs with BP controlled to less than 140/90 mmHg. 6) T2DM patients with UACR between 30 to 300 mg per grams.

Exclusion criteria

Exclusion criteria: 1) Type 1 Diabetes mellitus. 2) Other secondary forms of diabetes 3) Patients with HBA1c more than 8.5 (uncontrolled diabetes). 4) T2DM patients with uncontrolled hypertension (greater than 140/90mmHg). 5) T2DM patients using insulin. 6) T2DM patients using TZDs within 60 days prior to consent. 7) Known hypersensitivity to TZDs. 8) T2DM patients with overt albuminuria 9) H/O macular edema 10) Congestive cardiac failure 11) Ischemic stroke or cerebral haemorrhage. 12) Hepatic dysfunction 13) H/O fractures 14) Active infection and trauma 15) Unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Comparative assessment of the change in UACR from baseline between lobeglitazone and pioglitazone in both normotensive and hypertensive T2DM patients.Timepoint: 6 months	—

Secondary

Measure	Time frame
To study the effect of Lobeglitazone and Pioglitazone on UACR in normotensive T2DM patients.Timepoint: 6 months;To evaluate effect of Lobeglitazone and Pioglitazone on UACR in hypertensive T2DM patients.Timepoint: 6 months;To compare the effect of Lobeglitazone v/s Pioglitazone on UACR in normotensive and hypertensive T2DM patientsTimepoint: 6 months;To study and compare the effect of Lobeglitazone v/s Pioglitazone on Glycaemic parameters in both groups of T2DM patientsTimepoint: 6 months;To study and compare the safety of lobeglitazone v/s pioglitazone per se patient reported adverse drug reactionsTimepoint: 6 months	—

Measure

Time frame

To study the effect of Lobeglitazone and Pioglitazone on UACR in normotensive T2DM patients.Timepoint: 6 months;To evaluate effect of Lobeglitazone and Pioglitazone on UACR in hypertensive T2DM patients.Timepoint: 6 months;To compare the effect of Lobeglitazone v/s Pioglitazone on UACR in normotensive and hypertensive T2DM patientsTimepoint: 6 months;To study and compare the effect of Lobeglitazone v/s Pioglitazone on Glycaemic parameters in both groups of T2DM patientsTimepoint: 6 months;To study and compare the safety of lobeglitazone v/s pioglitazone per se patient reported adverse drug reactionsTimepoint: 6 months

—

Countries

India

Contacts

Public ContactDr Minakshi S ghuge

MGM medical college and hospital

jyobobde@gmail.com09423781558

Outcome results

None listed

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