CTRI/2021/08/035631已完成3 期
ââ?¬Å?A Phase III, Prospective, Randomized, Double Blind, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Vildagliptin SR 100 mg / 100 mg plus Metformin SR 500 mg / 1000 mg Tablets Versus FDC of Vildagliptin 50 mg plus Metformin 500 mg Tablets in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy.ââ?¬?
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. Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycemic control [Glycosylated Hemoglobin (HbA1c) levels of > 7% to ââ?°Â¤ 9%].
- •3. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •4. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with known hypersensitivity to Vildagliptin.
- •2. Patients with the history of Type 1 diabetes mellitus.
- •3. Patients with fasting plasma glucose (FPG) ââ?°Â¥ 200 mg/dl and/or glycosylated hemoglobin (HbA1c) >9%.
- •4. Patients who are accepting treatments of arrhythmias.
- •5.Patients with known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy.
- •6. Patients with known history of acute or chronic pancreatitis.
- •7. 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].
- •8. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
- •9. Patients with a history of New York Heart Association (NYHA) Class III or IV heart failure.
- •10. Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, gastric dysfunction, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety or difficult to evaluate the efficacy of the product.
- •11. Patients receiving treatment with systemic corticosteroids.
- •12. Patients with history of HIV and /or Hepatitis B and /or Hepatitis C.
- •13. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •14. Females who are not ready to use acceptable contraceptive methods during the course of study.
- •15. Patients with the history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to screening.
- •16. Patients with medical history of Oncological Conditions since last 5 years.
- •17. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •18. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •19. Suspected inability or unwillingness to comply with the study procedures.
- •20. Any other condition that in the opinion of the Investigator that does not justify the patientââ?¬•s participation in the study.
研究者
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