To check the relative ability of Vidavance to increase the level of glucose in the blood.
Phase 4
Completed
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2022/08/044917
- Lead Sponsor
- Dr Chetan Mehndiratta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Diabetic subjects ages 18-60 years
Fasting >120 mg / dL
No known food allergy or intolerance
Not taking any medications known to affect glucose tolerance.
Exclusion Criteria
Subjects on special diet restriction
Pregnant and lactating mothers with a known history of diabetes mellitus
Presence of disease or drug(s) that may influence digestion and absorption of nutrients and a major medical or surgical event in the last 3 months
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimation of the GI value of test product, using the iAUC <br/ ><br>Timepoint: CGM data will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes after the start of the test meal. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method ook for the hypoglycemic event (Blood sugar level less than 70 mg/dl for a period within 24 hrs) <br/ ><br>Look for hyperglycemic event (Blood sugar level more than 180 mg/dl for a period of 24 hrs) <br/ ><br>Look for the glycemic variation in the subjects <br/ ><br>Calculate the Time in Range (TIR) (the time spent by the subject in the target blood sugar range of 70-180 mg/dl) <br/ ><br>Timepoint: Within 24 hours of Continuous Glucose Monitoring (CGM)