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

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.

Timeline

Start

2009-10

Primary completion

2012-06

Completion

2012-10

Outcome

Mixed primary results

registry MEAN Placebo: 2.0 (Standard Error 0.2) mg/kg.min NCT00820573 ↗

registry MEAN Sitagliptin Plus Metformin: 1.5 (Standard Error 0.1) mg/kg.min NCT00820573 ↗

registry analysis (superiority or other test); Placebo vs Metformin vs Sitagliptin vs Sitagliptin Plus Metformin; p <0.05; ANOVA NCT00820573 ↗

registry MEAN Placebo: 1.8 (Standard Error 0.2) mg/kg.min NCT00820573 ↗

registry MEAN Sitagliptin + Metformin: 1.5 (Standard Error 0.2) mg/kg.min NCT00820573 ↗

registry analysis (superiority or other test); Placebo vs Metformin vs Sitagliptin vs Sitagliptin + Metformin; p = 0.05; ANOVA NCT00820573 ↗

Publications

• Solis-Herrera C, Triplitt C, Garduno-Garcia Jde J, Adams J, DeFronzo RA, Cersosimo E. Mechanisms of glucose lowering of dipeptidyl peptidase-4 inhibitor sitagliptin when used alone or with metformin in type 2 diabetes: a double-tracer study. Diabetes Care. 2013 Sep;36(9):2756-62. doi: 10.2337/dc12-2072. Epub 2013 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	1000 mg	—
Subject	Sitagliptin	Small molecule	100 mg	—

Indications