NCT00420511

Beta-Cell Function and Sitagliptin Trial (BEST)

A Randomized Controlled Pilot Study Assessing the Effect of Sitagliptin on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin. Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.

Detailed description

Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV (DPP-IV) inhibitors, may be able to protect beta cells and hence alter the natural history of T2DM. We thus wish to study the effect of sitagliptin (a DPP-IV inhibitor) on the preservation of beta-cell function in patients with T2DM randomized to either (i) sitagliptin and metformin or (ii) placebo and metformin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Sitagliptin	sitagliptin 100 mg once a day
DRUG	Placebo	placebo once a day
DRUG	metformin	metformin 1000 mg twice a day (bid) by mouth (po)

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-01-11
• Last updated: 2012-01-02
• Results posted: 2011-12-29

Locations

1 site across 1 country: Canada