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

Novartis28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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% 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

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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