A Clinical Trial to evaluate Glucose-Dependant Insulinotropic Effects of Single dose of a DPP-4 inhibitor
Phase 1
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000457
- Lead Sponsor
- MSD pharmaceutical pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Subject is an Asian Indian male between 18 to 45 years of age
Subject is in good health
Subject is a nonsmoker or has not used nicotine-containing products for six months
Subject is willing to avoid strenuous activity
Exclusion Criteria
Subject has a history of stroke, seizures, or major neurological disorders
Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain
Subject has a history of high blood pressure requiring treatment
Subject has history of cancer
Subject has a history of diabetes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insulin secretion rate (ISR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]<br><br><br>Timepoint: Insulin secretion rate (ISR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]<br><br><br>
- Secondary Outcome Measures
Name Time Method Glucose infusion rate (GIR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]<br><br><br>Timepoint: Glucose infusion rate (GIR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]<br><br><br>