A Clinical Evaluation of Efficacy and Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients - A Randomized, Single-center, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Monthly changes in fasting & postprandial plasma glucose levels
研究概览
简要总结
This study is aRandomized, Single-center, Double Blind, Placebo Controlled Study to Evaluate Efficacyand Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent(OHA) in Type 2 Diabetic Patients. Study will be conducted in 80 subjects (40subjects in each group) in India. The primary outcome measures will be assessmentof monthly changes in fasting & postprandial plasma glucose levels[baseline value, value on 30th day, 60th day, and 90th day of treatment] and assessmentof changes in HbA1C% (Glycosylated Hemoglobin) value [from baseline to end ofstudy value]. The secondary objectives would be assessment of Quality of Life(QOL) of patients will be done using WHO-QOL (brief) questionnaire (Appendix-D)[from baseline visit and on every alternate follow-up visit viz. Visit-II (day30), Visit-IV (day 60) and Visit-VI (day 90)], changes in Serum insulin level[from baseline to end of study value], reduction or increase in dose of OHAs [frombaseline to end of study], clinical symptoms of Type 2 DM i.e. Polydypsia, Polyphagia,Polyuria, & fatigue (refer appendix-C) [Time frame: 3 months], Global assessmentfor overall improvement will be done by the investigator and by the patienthimself / herself on study completion and assessment of safety. Tablet diabepaland matching placebo will be administered in a dose of 2 tablets twice dailyorally along with OHAs for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects suffering from Type 2 Diabetes Mellitus for more than one year,
- •Subject stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
- •Subjects having their fasting blood glucose in the range of 126 -252 mg/dl on screening visit
- •HbA1C in range of 7-11%
- •Subject’s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia
- •Subjects with controlled blood pressure and controlled lipid levels.
排除标准
- •1.Subjects on insulin therapy 2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2 3.Subjects having known hepatic or renal disease 4.Subjects having an active malignancy 5.Subjects with history of significant cardiovascular event < 12 weeks prior to randomization 6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
结局指标
主要结局
1.Monthly changes in fasting & postprandial plasma glucose levels
时间窗: Baseline value, value on 30th day, 60th day, and 90th day of treatment | 2.Changes in HbA1C% (Glycosylated Hemoglobin) value
2.Changes in HbA1C% (Glycosylated Hemoglobin) value
时间窗: Baseline value, value on 30th day, 60th day, and 90th day of treatment | 2.Changes in HbA1C% (Glycosylated Hemoglobin) value
次要结局
- 1.Quality of Life (QOL) of patients will be done using WHO-QOL(2.Changes in Serum insulin level)