Status:

COMPLETED

Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal...

Eligibility Criteria

Inclusion

  • Blood glucose criteria must be met
  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion

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

Key Trial Info

Start Date :

October 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2006

Estimated Enrollment :

274 Patients enrolled

Trial Details

Trial ID

NCT00101712

Start Date

October 1 2004

End Date

May 1 2006

Last Update

May 7 2012

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Novartis Investigative Site

Investigative Site, Germany

2

Novartis Investigative Site

Basel, Switzerland