A Study to Evaluate the Effect of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00351585
• Lead Sponsor: Novartis

Brief Summary

Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-11
• Study First Posted: 2006-07-13
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Diagnosed with type 2 diabetes for at least 6 months
• Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
• BMI in the range 22-45
• Blood glucose criteria must be met

Exclusion Criteria

• Pregnancy or lactation
• Type 1 diabetes or diabetes resulting from pancreatic injury
• Cardiovascular complications as defined by the protocol
• Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in maximal insulin secretory capacity at 12 weeks
Durability of this effect after a 2-week washout

Secondary Outcome Measures

Name	Time	Method
Change from baseline in beta-cell sensitivity to glucose at 12 weeks
Durability of this effect after a 2-week washout
Chance from baseline in glucagon secretion at 12 weeks