Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00390520

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment []

Secondary Outcome Measures

Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment []
The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment []
Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose []
Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months
/= 18 years
Body mass index in the range of 22-35 kg/m2
HbA1c </=7.5%