CTRI/2019/12/022548已完成3 期
A Phase III, Randomized, Double Blind, Parallel Group, Non-Comparative Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of FDC of Rosuvastatin plus Teneligliptin Tablets in patients suffering from Dyslipidemia associated with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 252
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
- •1. Male or female patients aged between 18 to 65 years (both inclusive).
- •2. Patient diagnosed with Dyslipidemia and Type 2 diabetes defined as: LDL-C >= 100 mg/dl and <= 250 mg/dl & HbA1c Levels >= 7% and <= 8.5%.
- •3. Patients who had receiving a stable dose of Metformin (>= 1000 mg /day) for at least 3 months prior to screening.
- •4. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •5. Patients willing to comply with the protocol requirements.
排除标准
- •1. Any known contraindications to Rosuvastatin or Teneligliptin or related class of drugs.
- •2. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
- •3. Patients with known case of type 1 diabetes mellitus.
- •4. Patients with glycosylated hemoglobin (HbA1c) >8.5%.
- •5. Patients with Body mass index (BMI) higher than 40 kg/m2.
- •6. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •7. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
- •8. Patients with the history of severe heart disease (angioplasty, stent placement, bypass surgery, myocardial infarction, unstable angina pectoris, New York Heart Association class III, IV congestive heart failure, or ventricular arrhythmia within 6 months before screening).
- •9. Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy.
- •10. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •11. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •12. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension or other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
- •13. Patients who have participated in any clinical trial in the past 3 months.
- •14. Patients who are known cases of HIV, Hepatitis B or Hepatitis C.
- •15. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
- •16. Patients with medical history of Oncological Conditions since last 5 years.
- •17. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •18. Suspected inability or unwillingness to comply with the study procedures.
- •19. Any other condition that in the opinion of the Investigator that does not justify the patientâ??s participation in the study.
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