Safety and efficacy of Saroglitazar in type 2 diabetes mellitus patients

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2015/09/006203
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

A Phase III of 12 week duration to evaluate the efficacy and safety of Saroglitazar in diabetic dyslipidemic patients not controlled with atorvastatin 10 mg revealed statistically significant reduction in the TG levels as compared to placebo. Statistically significant reduction in the LDL cholesterol, total cholesterol and apolipoprotein B levels with Saroglitazar 4 mg was observed as compared to baseline. Thus far,Saroglitazar clinical studies have included mild to moderate dyslipidemic patients and showed favorable effects .

The preclinical and clinical experience of Saroglitazar showed favourable effects not only on lipid profile but also glycemic control. . Thus based on the result of above studies   the present study is proposed to assess the effects of 2 mg and 4 mg of Saroglitazar as compared to Pioglitazone 30 mg in patients with T2DM.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1140

Inclusion Criteria

• Subjects age 18- 75 years, of either sex.
• Documented history of type 2 diabetes mellitus defined by ADA criteria.
• History of stable metformin dose atleast since last 6 weeks (total daily dose should not exceed 2 gm) in conjunction with diet and exercise.
• Fasting plasma glucose ≤270 mg/dL (14.98 mmol/L).
• HbA1c should be ≥7.5%.
• Subject has given informed consent for participation in this trial.

Exclusion Criteria

• Type 1 diabetes mellitus or a history of ketoacidosis or secondary forms of diabetes.
• Subjects who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
• History of recurrent or severe hypoglycemia within in last 3 months.
• History of acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• Subjects on glitazone / glitazar therapy in the past 1 month.
• History of uncontrolled thyroid disorder, not controlled by thyroid modulating drugs.
• 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).
• Subjects with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4).
• Uncontrolled hypertension (BP160/100 mmHg).
• History of cancer (except non-melanoma skin cancer) or unexplained haematuria.
• Subjects with an alanine transaminase (ALT) level ≥2.5 times the upper normal limit (UNL), active liver disease, or jaundice.
• Subject with systemic corticosteroid therapy for 2 week within past 3 months or history of chronic or recurrent use.
• History of any hemoglobinopathy (such as hemolytic anemia or sickle cell disease) that may affect determination of HbA1c.
• Subjects with microscopic hematuria.
• History of AIDS / HIV infection.
• History of viral hepatitis B or C.
• Pregnant or breastfeeding female.
• Subjects with any medical condition that may complicate participation in the trial.
• Subjects who is unsuitable for the study according to the investigator.
• Subjects who have participated in any trial in past 3 months.
• Subjects who are unable to understand and give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycosylated hemoglobin (HbA1c) for	Week 24
Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg	Week 24

Secondary Outcome Measures

Name	Time	Method
Comparision of Change from baseline in glycosylated hemoglobin	(HbA1c) between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg
Change from baseline in glycosylated hemoglobin (HbA1c) for	Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg
Comparision of Change from baseline in fasting plasma glucose between	Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg
Change from baseline in fasting plasma glucose for Saroglitazar 4 mg, 2	mg and Pioglitazone 30 mg
Change from baseline in 2 hour postprandial plasma glucose for	Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg
Change from baseline in lipid profile and lipoprotein.	Triglyceride (TG) cholesterol

Trial Locations

Locations (41)

Apex Hospital Pvt Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Aster Aadhar HospitalÂ; 🇮🇳 Kolhapur, MAHARASHTRA, India

Aware Global HospitalÂ; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

BAPS pramukh Swami Hospital; 🇮🇳 Surat, GUJARAT, India

Bhatia Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Department of GeneralMedicine Rajiv Gandhi Institute of Medical Science; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Department of Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

DHL Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Diabetes Care& Research Centre; 🇮🇳 Bikaner, RAJASTHAN, India

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Apex Hospital Pvt Ltd

🇮🇳Jaipur, RAJASTHAN, India

Dr Vipul Khandelwal

Principal investigator

9829193517

dr.vipul@yahoo.co.in