Safety and efficacy of Saroglitazar in type 2 diabetes mellitus patients

A Multi-centric, Prospective, Randomized, Double- blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 / 4 mg as Compared to Pioglitazone in Type 2 Diabetes Mellitus - PRESS XII

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006203

Enrollment

1140

Registered

2015-09-22

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

Interventions

Intervention1: Saroglitazar: Dosage:-2mg and 4mg Route:-Oral Form:-Tablet Duration :-OD for 56 weeks Control Intervention1: Pioglitazone: Dosage:-30mg Route:-Oral Form:-Tablet Duration :-OD for 56 w

Eligibility

Inclusion criteria

Inclusion criteria: Subjects age 18- 75 years, of either sex. 2. Documented history of type 2 diabetes mellitus defined by ADA criteria. 3. History of stable metformin dose atleast since last 6 weeks (total daily dose should not exceed 2 gm) in conjunction with diet and exercise. 4. Fasting plasma glucose 5. HbA1c should be >=7.5%. 6. Subject has given informed consent for participation in this trial.

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus or a history of ketoacidosis or secondary forms of diabetes. 2. Subjects who have been treated with insulin for >=7 days within 3 months prior to the screening visit. 3. History of recurrent or severe hypoglycemia within in last 3 months. 4. History of acute or chronic metabolic acidosis, including diabetic ketoacidosis. 5. Subjects on glitazone / glitazar therapy in the past 1 month. 6. History of unstable or rapidly progressive diabetic retinopathy, nephropathy (serum creatinine 1.5 mg/dL). 7. History of uncontrolled thyroid disorder, not controlled by thyroid modulating drugs. 8. History of clinically significant peripheral edema in past 3 months. 9. Subjects with coronary insufficiency (e.g., a myocardial infarction, a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident within 6 months prior to the screening visit). 10. Subjects with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4). 11. Uncontrolled hypertension (BP160/100 mmHg). 12. History of cancer (except non-melanoma skin cancer) or unexplained haematuria. 13. Subjects with an alanine transaminase (ALT) level >=2.5 times the upper normal limit (UNL), active liver disease, or jaundice. 14. Subject with systemic corticosteroid therapy for 2 week within past 3 months or history of chronic or recurrent use. 15. History of any hemoglobinopathy (such as hemolytic anemia or sickle cell disease) that may affect determination of HbA1c. 16. Subjects with microscopic hematuria. 17. History of AIDS / HIV infection. 18. History of viral hepatitis B or C. 19. Pregnant or breastfeeding female. 20. Subjects with any medical condition that may complicate participation in the trial. 21. Subjects who is unsuitable for the study according to the investigator. Subjects who have participated in any trial in past 3 months. 22. Subjects who are unable to understand and give informed consent.

Design outcomes

Primary

Measure	Time frame
Change from baseline in glycosylated hemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 24	—

Secondary

Measure	Time frame
Change from baseline in 2 hour postprandial plasma glucose for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56;Change from baseline in fasting plasma glucose for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56];Change from baseline in glycosylated hemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12,and Week 56;Change from baseline in lipid profile and lipoprotein. Triglyceride (TG) cholesterol Low density lipoprotein (LDL) cholesterol Very low density lipoprotein (VLDL) cholesterol High density lipoprotein (LDL) cholesterol Total cholesterol (TC) cholesterol,Non HDL cholesterol Apolipoprotein (Apo) A1 Apo B.Timepoint: Week 12, Week 24, and Week 56;Comparision of Change from baseline in fasting plasma glucose between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56;Comparision of Change from baseline in glycosylated hemoglobin (HbA1c) between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56]	—

Measure

Time frame

Change from baseline in 2 hour postprandial plasma glucose for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56;Change from baseline in fasting plasma glucose for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56];Change from baseline in glycosylated hemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12,and Week 56;Change from baseline in lipid profile and lipoprotein. Triglyceride (TG) cholesterol Low density lipoprotein (LDL) cholesterol Very low density lipoprotein (VLDL) cholesterol High density lipoprotein (LDL) cholesterol Total cholesterol (TC) cholesterol,Non HDL cholesterol Apolipoprotein (Apo) A1 Apo B.Timepoint: Week 12, Week 24, and Week 56;Comparision of Change from baseline in fasting plasma glucose between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56;Comparision of Change from baseline in glycosylated hemoglobin (HbA1c) between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 12, Week 24, and Week 56]

—

Countries

India

Contacts

Public ContactDr Deven Parmar

Zydus Research Center

deven.parmar@zyduscadila.com91-2717-665555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026