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Clinical Trials/NCT00351585
NCT00351585
Completed
Phase 3

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus

Novartis0 sites39 target enrollmentJuly 2004
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ConditionsDiabetes Mellitus, Type 2
DrugsVildagliptin

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Novartis
Enrollment
39
Primary Endpoint
Change from baseline in maximal insulin secretory capacity at 12 weeks
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
September 2005
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in maximal insulin secretory capacity at 12 weeks

Durability of this effect after a 2-week washout

Secondary Outcomes

  • 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

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