CTRI/2015/09/006203进行中（未招募）3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
- •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.
研究者
相似试验
招募中
4 期
Efficacy and safety of Saroglitazar (LipaglynTM) as Compared to Fenofibrate in Patients With Dyslipidemia (PRESS X)].CTRI/2013/06/003754Cadila Healthcare Limited1,010
已完成
3 期
A clinical study to assess the efficacy and safety of combination of Dapagliflozin plus TeneligliptinTablets in patients with diabetes.CTRI/2021/11/038050Synokem Pharmaceuticals Ltd293
已完成
2 期
Study the safety and efficacy of PMZ-2010 in patients with shock due to blood loss.CTRI/2017/03/008184Pharmazz India Private Limited50
已完成
2 期
To Study the effect of PMZ-1620 in stroke patients.CTRI/2017/11/010654Pharmazz India Private Limited40
进行中（未招募）
2 期
Effect of PMZ-1620 in Alzheimers disease.CTRI/2017/12/011003Pharmazz India Private Limited80