An Prospective, Open label, Multicentric, Non-Comparative, study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- -No. of patients achieving HbA1C 7%
研究概览
简要总结
An Prospective, Open label, Multicentric, Non-Comparative study to evaluate the efficacy, safety and tolerability of fixed dose combination [FDC] Voglibose 0.3mg + Metformin (SR ) 500mg in treatment of patients with Type II diabetes.
The study will be conducted at two centres in India only. A total of 110 patients will be enrolled in the study.
Then newly diagnosed type2 diabetes patients will be allocated treatment with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet once a day. The patients with uncontrolled glycemia on monotherapy with Metformin 1000 mg will be treated with fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg one tablet twice a day. [Maximum 3 tablets of fixed dose combination of Voglibose 0.3 mg + Metformin (SR) 500mg will be allowed] Patients who do not respond to maximum dose will be considered as treatment failures and will be excluded from the study and will be treated as per Investigators Discretion.
HbA1C , FPG and PPG will be assessed at Day 30 and Day 90 , depending upon the HbA1c criteria the dose of the drug will be titrated and patient will be followed up till 180 days to evaluate-
-No. of patients achieving HbA1C < 7%,
- Percentage reduction of fasting plasma glucose (FPG) from baseline.
- Percentage of subjects achieving an HbA1C decrease by >1%
*-*Percentage reduction of PPG from baseline.
- Global assessment for efficacy and tolerability by investigator and patientsxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.18 years of age, upper limit at the discretion of Investigator.
- •2.Patients diagnosed of type 2 diabetes as defined by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (Appendix B) at least 6 months prior to screening 3.Newly diagnosed Type 2 diabetes mellitus patients 4.Patients with type 2 diabetes mellitus who had previously received at least 3 months of continuous treatment with oral therapy of Metformin 1000 mg alone and is inadequately controlled [HbA1c 8% and HbA1c 11 %] during screening visit 5.Patient with BMI between 20 – 35 Kg/m2 6.Patients whose baseline fasting plasma venous glucose (FPG) concentration ranging from 126mg/dl but 200mg/dl 7.Patients whose venous plasma glucose concentration is 200 mg/dl at 2hr postprandial (after a meal) but 300mg/dl 8.Patients with stable dietary and exercise pattern since three month and willing to follow the same for entire trial duration.
- •9.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.
排除标准
- •1.Type-1 diabetes mellitus 2.Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the last 12 months 3.Cardiac status New York Heart Association (NYHA) III-IV 4.Uncontrolled Blood pressure [ 140 Systolic and 90 Diastolic] 5.Impaired renal function as shown by, but not limited to, serum creatinine ¡Ý 1.5 mg/dL for males, or ¡Ý 1.4 mg/dL for females 6.Clinically significant peripheral edema 7.Acute infection 8.Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis 9.Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range 10.Patients on steroids 11.Patient with anticipated need of surgery within study period.
- •12.Patient known to be suffering from any bleeding disorder.
- •13.Pregnancy or lactating women 14.Known hypersensitivity to any of the study drugs.
- •15.Any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ 16.Current addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years 17.Diagnosis of dementia 18.Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 19.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 20.Any disease or condition that in the opinion of the investigator may interfere with the completion of the study.
结局指标
主要结局
-No. of patients achieving HbA1C 7%
时间窗: Baseline Day30 Day90 and Day180
-Percentage reduction of fasting plasma glucose (FPG) from baseline.
时间窗: Baseline Day30 Day90 and Day180
次要结局
- -Percentage of subjects achieving an HbA1C decrease by 1%(-Percentage reduction of PPG from baseline.)