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Clinical Trials/NCT00101673
NCT00101673CompletedPhase 3

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Novartis Pharmaceuticals1 site in 1 country251 target enrollmentStarted: March 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
251
Locations
1
Primary Endpoint
Change from baseline in HbA1c at 12 weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Blood glucose criteria must be met
  • •Not currently on drug therapy for type 2 diabetes
  • •Body mass index (BMI) in the range 22-45

Exclusion Criteria

  • •Pregnancy or lactation
  • •Type 1 diabetes
  • •Evidence of serious diabetic complications
  • •Evidence of serious cardiovascular conditions
  • •Laboratory value abnormalities as defined by the protocol
  • •Other protocol-defined exclusion criteria may apply

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 12 weeks

Secondary Outcomes

  • Adverse event profile after 12 weeks of treatment
  • Patients with reduction in HbA1c >/= 0.7% after 12 weeks
  • Change from baseline in fasting plasma glucose at 12 weeks
  • Change from baseline in HOMA-B at 12 weeks
  • Change from baseline in body weight at 12 weeks

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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