A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

Novartis Pharmaceuticals59 enrolled

Overview

This study is not being conducted in the United States. The purpose of this study is to assess the effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Not currently on drug therapy for type 2 diabetes * Blood glucose criteria must be met Exclusion Criteria: * History of type 1 diabetes * Evidence of significant diabetic complications * Serious cardiovascular events within the past 6 months * Other protocol-defined exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks

Time frame: 52 weeks

Secondary Outcomes

Change from baseline in disposition index at 52 weeks

Time frame: 52 weeks

Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks

Time frame: 52 weeks

Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks

Time frame: 52 weeks

Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks

Time frame: 52 weeks

Beta-cell function parameter derived from standard meal challenge

Time frame: 52 weeks

Data from ClinicalTrials.gov

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