Phase 1
Completed N=27
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
The Methodology Assessment of Glucose Dependent Insulin Secretion
Source: ClinicalTrials.gov NCT00782418 ↗
Enrolled (actual)
27
Serious AEs
1.8%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose — 2.14; 1.49; 0.53; 2.95 (ng/min) / (mg/dL) — p=<0.001
Summary
This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose |
2.14; 1.49; 0.53; 2.95; 2.07; 0.71 | <0.001 sig |
| PRIMARY Change From Baseline in C-peptide Concentration |
29.3; 22.6; 6.24 | <0.001 sig |
| PRIMARY Change From Baseline in Insulin Concentration |
592; 293; 46.5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
- Subject is judged to be in good health
- Subject has been a nonsmoker for at least 3 months
- Subject is willing to avoid strenuous physical activity for the duration of the study
Exclusion Criteria
- Subject has a history of high blood pressure requiring treatment
- Subject has a history of diabetes or a family history of diabetes mellitus
- Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
- Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
- Subject has multiple and/or severe allergies to foods or drugs
- Subject is a regular user of illegal drugs
- Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Data sourced from ClinicalTrials.gov (NCT00782418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.