| Trial ID: | L1932 |
| Source ID: | NCT00820573
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00820573/results
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Metformin|DRUG: Sitagliptin + Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP)., Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants, 6 weeks|Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks)., The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups., 6 weeks | Secondary: Fasting Plasma Glucose 6 Weeks After Therapy, Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups., 6 weeks|Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline, The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups., 360 min
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| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-10
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| Completion Date: |
2012-10
|
| Results First Posted: |
2013-12-13
|
| Last Update Posted: |
2013-12-13
|
| Locations: |
Texas Diabetes Institute, San Antonio, Texas, 78207, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00820573
|
