Skip to main content
OpenTrials
Completed

NCT Number: NCT00099866

Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis investigative Site

Investigative Sites, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Type 1 diabetes
  • Pregnancy or lactation
  • 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

Treatment and study plan

Vildagliptin

Drug

Other names: LAF237A

Metformin Comparator

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 52 weeks

Secondary outcomes

  1. Change from baseline in fasting plasma glucose at 52 weeks

  2. Adverse event profile after 52 weeks of treatment

  3. Change from baseline in body weight at 52 weeks

  4. Change from baseline in fasting lipids at 52 weeks

  5. Change from baseline in HOMA B at 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 22, 2004
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.