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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Vildagliptin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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).

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 Exclusion Criteria:

- Type 1 diabetes

- Acute metabolic diabetic complications

- Evidence of significant diabetic complications

- Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply

Novartis, Basel, Switzerland

Starting date: September 2006
Last updated: July 13, 2009