| Trial ID: | L1989 |
| Source ID: | NCT00830076
|
| Associated Drug: |
Sitagliptin Phosphate
|
| Title: |
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00830076/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: sitagliptin phosphate|DRUG: metformin hydrochloride|DRUG: Comparator: placebo sitagliptin|DRUG: Comparator: placebo metformin
|
| Outcome Measures: |
Primary: Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations, Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period., 6 hours postdose (4 hours postmeal) on Day 2 | Secondary: β-cell Sensitivity, β-cell sensitivity was defined as the incremental post-prandial 4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC., 6 hour post-dose (4 hour postmeal) on Day 2|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations, Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period., 6 hours postdose (4 hours postmeal) on Day 2
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-12-02
|
| Completion Date: |
2009-05-14
|
| Results First Posted: |
2011-11-03
|
| Last Update Posted: |
2017-05-15
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00830076
|