NCT00820573

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY: 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. SECONDARY: In patients with type 2 diabetes with inadequate glycemic control on diet and exercise after 6 weeks of treatment: 1. Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on post-meal glucose during meal tolerance test (MTT). Hypothesis: After 6 weeks of treatment the co-administration of sitagliptin and metformin provides greater reduction in the total glucose AUC (0-6 hr) during MTT compared to placebo. 2. Objective: To assess the effects of co-administration of sitagliptin and metformin compared to placebo on fasting plasma glucose (FPG). Hypothesis: After 6 weeks of treatment the co-administration of sitagliptin and metformin provides greater reduction in FPG compared to placebo. 3. Objective: To assess the effects sitagliptin alone compared to placebo on HGP. Hypothesis: After 6 weeks of treatment, sitagliptin alone provides greater reduction in HGP compared to placebo EXPLORATORY OBJECTIVES: (i) Objective: after 6 weeks of treatment, to assess the effects co-administration of sitagliptin and metformin compared to placebo on: 1. active and inactive incretin concentrations (fasting and post-meal GLP-1 and fasting and post-meal GIP). 2. glucagon concentration (fasting and post-meal). 3. parameters of insulin secretion and insulin sensitivity. 4. splanchnic glucose uptake. (ii) Objective: after 6 weeks of treatment, to assess the effects co-administration of sitagliptin and metformin compared to treatment with sitagliptin alone and metformin alone on: 5. glucose concentration (fasting and total glucose AUC \[0-6 hr\]). 6. active and inactive incretin concentrations (fasting and post-meal GLP-1 and fasting and post-meal GIP). 7. glucagon concentration (fasting and post-meal). 8. parameters of insulin secretion and insulin sensitivity. 9. HGP. 10. splanchnic glucose uptake. (iii) Objective: after 6 weeks of treatment, to assess the effects of sitagliptin alone and metformin alone compared to placebo on: 11. glucose concentration (fasting and total glucose AUC \[0-6 hr\]). 12. active and inactive incretin concentrations (fasting and post-meal GLP-1 and fasting and post-meal GIP). 13. glucagon concentration (fasting and post-meal). 14. parameters of insulin secretion and insulin sensitivity. 15. HGP. 16. splanchnic glucose uptake.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Sitagliptin	tablet, 100 mg/day, 6 weeks
DRUG	Metformin	tablet, 1000 mg/ bid, 6 weeks
DRUG	Sitagliptin + Metformin	tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks
DRUG	Placebo	Placebo 6 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-06-01
• Completion: 2012-10-01
• First posted: 2009-01-12
• Last updated: 2013-12-13
• Results posted: 2013-12-13

Locations

1 site across 1 country: United States