A Randomized, Double Blind, Double Dummy, Comparative, Prospective, Multicenter, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Teneligliptin and Metformin Tablet Compared with Metformin monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 56
- 主要终点
- Mean Change in Glycosylated Haemoglobin (HbA1c) levels
研究概览
简要总结
This is double-blind, double dummy, randomized, active controlled, two-arm, parallel-group, comparative study. Study will enroll 378 subjects with type 2 diabetes from the different centres in India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1 ratio to receive either Fixed Dose Combination of Teneligliptin and Metformin or Metformin for 24 weeks. The primary objective of the study is to see the mean change in Glycosylated Haemoglobin (HbA1c) levels at the end of treatment. Secondary objective includes proportion of patients achieving the goal of ≤7.0% HbA1c level, mean change for fasting and postprandial plasma glucose. During the study, there will be 7 study visits for efficacy, safety and tolerability assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients age ≥18 and ≤65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
- •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 glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of >7% to ≤ 9%].
排除标准
- •Pregnant or lactating women.
- •Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
- •Patient with Type 1 diabetes mellitus or secondary form of diabetes.
- •Patients with known hypersensitivity to any of the components of the formulation.
- •Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
- •Patients who have a recent history or who are currently known to abuse alcohol or drugs.
- •Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, collagen disorders, severe infection etc.
- •or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
- •Patients receiving treatment with systemic corticosteroids.
- •Patients who have participated in any clinical trial in the past 1 month.
- •Any other condition that in the opinion of the Investigator that does not justify the patient’s participation in the study.
结局指标
主要结局
Mean Change in Glycosylated Haemoglobin (HbA1c) levels
时间窗: 24 weeks
次要结局
- Proportion of patients achieving the goal of HbA1c ≤7% level(24 weeks)
- Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)(24 weeks)