CTRI/2023/06/053737已完成不适用
A Prospective, Multi-center, Parallel-Group study to evaluate the Efficacy & Safety of Vildagliptin 100 mg Sustained Release Tablet once daily compared to Sitagliptin 100 mg Tablet in patients with Type 2 diabetes mellitus not optimally controlled on metformin alone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Change in HbA1C
研究概览
简要总结
Vildagliptin 100 mg SR Tablet once daily formulation is developed to ensure better patient compliance towards effective glycemic control while reducing the frequency of dosing. In this context, a non-inferiority study is planned in type 2 diabetic patients in comparison with that of sitagliptin 100 mg with or without metformin.The key principle behind the development of Vildagliptin 100 mg SR once daily formulation is to ensure better patient adherence towards effective glycemic control while reducing the frequency of dosing.Vildagliptin and Sitagliptin are the pioneer drugs in the DPP4i class and the most widely studied as well. Therefore, a detailed study comparing the effectiveness of the 2 drugs would add sufficient data in the scientific literature
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients of >18 years of age diagnosed with type 2 diabetes using American Diabetes Association Criteria; Treated with metformin monotherapy at a stable dose (≥1,000 mg per day) for at least one month before randomization.
- •2.Patients who are willing to comply with continues glucose monitoring system will be included in CGMS group.
- •3.Patients who are uncontrolled on metformin with HbA1c of >7%.
- •4.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol-specific procedures are performed.
- •5.Patients with body mass index (BMI) 18.0 to 35.0 kg/m2.
排除标准
- •Type-1 diabetes mellitus.
- •Patients who are on more than two oral anti-diabetic drugs or on insulin.
- •Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg).
- •Symptomatic heart failure.
- •Severe hepatic dysfunction (alanine aminotransferase or aspartate aminotransferase levels more than three times the normal upper limit).
- •Patients with known hypersensitivity to Vildagliptin or Metformin HCl or Sitagliptin to any of the excipients.
- •Patients with severe renal impairment.
- •Patients with acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis, with or without coma.
- •Subjects who are pregnant or are currently breast-feeding.
- •Patient who is an employee of the Investigator or the Institution, or a patient who has direct involvement with the trial or other trials under the direction of the Investigator.
- •Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of drugs or devices, or has been previously randomized in this trial.
- •Laboratory value abnormalities as defined by the protocol
- •Evidence of serious diabetic complications.
- •Patients who are Hepatitis B or C or HIV positive.
- •Patients who have undergone pancreatectomy or pancreas/islet cell transplant.
- •Patient with history or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, endocrinology, renal, hepatic, pulmonary, gastrointestinal, musculoskeletal, peripheral vascular, psychiatric, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study.
结局指标
主要结局
Change in HbA1C
时间窗: Change in HbA1c at baseline(screening)and day 84
次要结局
- Percentage reduction of Fasting Blood Glucose (FBG) levels(Percentage reduction of Postprandial Blood Glucose (PPBG) levels)
研究者
研究点 (4)
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