An Interventional Trial to Evaluate the Impact of GLUBLOCâ„¢ on HbA1c levels, Glycemic Variability and Time in Range in Type 2 diabetic individuals.
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- A reduction in HbA1c levels, improvement in glycemic Variability and time in range (based on CGM measurements) with GLUBLOCâ„¢ treatment in Type 2 diabetic individuals.
研究概览
简要总结
In this investigator initiative study, Twenty, Type 2 diabetic individuals with HbA1c levels 6.5 to 11%, with or without any other potential comorbidities, as per the inclusion criteria will be enrolled for the study.
After enrollment, A pre-treatment phase with Lifestyle libre will be done for 14 days to capture glycemic Variability and Time in range.
After 14 day pre-treatment phase, subjects will be instructed to take two GLUBLOC tablets per day, along with two major meals (ie., lunch and dinner), for 180 days.
Subjects will be administered Lifestyle libre device on Day 76 (Data will be captured till Day 90) and on Day 166 (Data will be captured till Day 180) to observe glycemic control while using GLUBLOC, when compared to baseline.
HbA1c levels will be estimated at baseline, and at each subsequent months (Baseline (Day 0), Day 60, Day 90 and Day 180). At the end of treatment period, percentage change in HbA1C, Glycemic Variability and Time in range will be estimated.
Blood biochemistry will be conducted at the time of baseline (Day 0) and the subsequent visits (Day 60, Day 90 & Day 180).
Liver and Kidney function parameters will be assessed.
At the baseline and during the subsequent follow-ups (Day 0, Day 60, Day 90 and Day 180), anthropometric parameters like Body weight, BMI, Height, Weight, waist-to-hip ratio and a self administered questionnaire to assess the subjective feeling of energy in the past one week will be collected.
Questions related to gastrointestinal discomfort will be asked, such as, nausea, abdominal cramp, distension and flatulence. Any adverse events experienced during the study will be captured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •65 years old male and non-pregnant females Diagnosis of Type 2 Diabetes Mellitus for at least 6 months; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas) for at least 3 months before screening. Participants with HbA1c between 7 to 11 percent Participant willing to provide informed consent and willing to comply with study procedures.
排除标准
- •Type 1 Diabetes Mellitus participants. Type 2 Diabetes Mellitus participants on insulin, Thiazolidinediones, GLP-1 agonists, DPP-IV inhibitors, AGI’s and/or SGLT2 inhibitors. Allergy to one or more components of the investigational product or history of food allergies Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start. Participant taking any herbal/ayurvedic/ alternative medicine preparations that could profoundly affect blood glucose. Females who are nursing / pregnant / are of child.
- •bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s. Participant with active infection in past 30 days. Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage. Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months. Participants with history of bariatric surgery. Participant has any major or minor surgery within 30 days prior to screening.
结局指标
主要结局
A reduction in HbA1c levels, improvement in glycemic Variability and time in range (based on CGM measurements) with GLUBLOCâ„¢ treatment in Type 2 diabetic individuals.
时间窗: Day 0 (Baseline), day 60, day 90 and day 180.
次要结局
- A reduction in Weight, waist-hip ratio, BMI and subjective feeling of energy(Baseline (day 0), day 60, day 90 and day 180.)
研究者
DR K. Somnath Gupta
Yashoda Hospitals