Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM
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|ClinicalTrials.gov Identifier: NCT00820573|
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment:
Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on hepatic glucose production (HGP).
Hypothesis: After 6 weeks of treatment, the co-administration of sitagliptin and metformin provides greater reduction in hepatic glucose production (HGP) compared to placebo.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: Sitagliptin Drug: Metformin Drug: Sitagliptin + Metformin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||October 2012|
Placebo Comparator: Placebo
Placebo to be provided for 6 weeks
Placebo 6 weeks
Other Name: Placebo tablet
Sitagliptin to be provided for 6 weeks
tablet, 100 mg/day, 6 weeks
Other Name: Januvia
Metformin to be provided for 6 weeks
tablet, 1000 mg/ bid, 6 weeks
Other Name: Glucophage
Sitagliptin + Metformin combined will be provided for 6 weeks
Drug: Sitagliptin + Metformin
tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks
Other Name: Januvia and glucophage
- Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP). [ Time Frame: 6 weeks ]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
- Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks). [ Time Frame: 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.
- Fasting Plasma Glucose 6 Weeks After Therapy [ Time Frame: 6 weeks ]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.
- Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline [ Time Frame: 360 min ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820573
|United States, Texas|
|Texas Diabetes Institute|
|San Antonio, Texas, United States, 78207|
|Principal Investigator:||Eugenio Cersosimo, MD||University of TX Health Science Center|