Single arm, open label, prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess change from Baseline in Fasting Plasma Glucose (FPG).
研究概览
简要总结
Diabetes mellitus (DM) is rising in India with more than 62 million diabetic individuals. India (31.7 million) topped world with highest number of people with DM followed by US. Prevalence of DM is predicted to double globally from 171 in 2000 to 366 million in 2030. The prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with DM is conducted. At two sites, 30 subjects were evaluated till 60 days for Fasting Plasma Glucose (FPG), Post Meal Glucose (PMG) and HbA1c. At initial, mean FPG level was 344.70 ± 80.12 mg/dl, for day 60 it was reduced 155.80 ± 31.44 mg/dl. At baseline visit, the mean PMG level was 436.22 ± 102.73 mg/dl, for day 60 it was reduced to 204.87 ± 27.74 mg/dl and HbA1C % was 10.35 ± 1.95, for day 60 it was reduced to 7.34± 0.97 mg/dl. The reduction in clinical symptoms of patients is also reported. The success of product as an adjuvant therapy can be explained as it caused reduction in doses of insulin and OHA in test population at 60 days. It can be concluded that adjuvant therapy of Gplife Advanced Diabetic Support Tablet significantly effective in reducing levels of fasting plasma glucose (FPG) and Post meal plasma glucose (PMG) from baseline till 60 days. No significant change in any of the safety laboratory parameters and vitals was observed suggesting safety of the Gplife Advanced Diabetic Support Tablet.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18-60 (both inclusive) age, both sex.
- •Patients receiving Oral Hypoglycemic Agents and/or insulin as on-going treatment for diabetes Haemoglobin A1C (HbA1c) >6.5% and <14.5 % (both inclusive) Subjects having a body mass index (BMI) of 20 to 35 kg/m
- •Fasting Plasma Glucose (FPG) >120 mg/dL and < 450 mg/dL (both inclusive).
排除标准
- •â€¢Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •â€¢Women who are pregnant or lactating •Smokers/Alcoholics and/or drug abusers •Patients with evidence of malignancy •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.) •Involvement in any other study requiring drug therapy •Renal dysfunction as evidenced by raised serum creatinine from renal function test •Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) •Unwillingness to undergo therapy •Known hypersensitivity to any of the ingredients of study tablets •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
To assess change from Baseline in Fasting Plasma Glucose (FPG).
时间窗: Baseline and end of study
To assess change from Baseline in 2 Hr. Post Meal Glucose (PMG) to 60 days.
时间窗: Baseline and end of study
To evaluate change from Baseline in Haemoglobin A1c (HbA1c)
时间窗: Baseline and end of study
To assess change from Baseline in Fasting Insulin (FI)
时间窗: Baseline and end of study
To assess change from Baseline in 2 hr. Post Meal Insulin (PMI).
时间窗: Baseline and end of study
次要结局
- Reduction in dose of OHAs(To evaluate changes of [HOMA]-b, insulin resistance (IR) by HOMA-IR)