NCT02443922

Dynamic Responsiveness of Insulin Secretory Parameters To Sitagliptin and Glimeperide Administration in Type 2 DM

Dynamic Responsiveness of Insulin Secretory Parameters to Sitagliptin and Glimeperide Administration in Subjects With Type 2 Diabetes Mellitus: An Open Label Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Foundation for the National Institutes of Health · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.

Detailed description

A three-year observational study to standardize the meal tolerance and maximal stimulation tests for measuring beta cell function in the clinical setting. It also aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression. The objective of this protocol is to establish the dynamic responsivity of the methods to treatment with glimerpiride or sitagliptin.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Glimepiride	Glimepiride 2mg qam
DRUG	Sitagliptin	Sitagliptin 100mg qam
DRUG	Metformin	Metformin as prescribed

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-05-14
• Last updated: 2015-05-14