Safety and efficacy of Saroglitazar in type 2 diabetes mellitus patients
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2015/09/006203
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <=270 mg/dL (14.98 mmol/L).
5. HbA1c should be >=7.5%.
6. Subject has given informed consent for participation in this trial.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in glycosylated hemoglobin (HbA1c) for <br/ ><br>Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mgTimepoint: Week 24
- Secondary Outcome Measures
Name Time Method