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OpenTrials
Completed

NCT Number: NCT00138567

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

This is a 52-week extension to a study 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. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

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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–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative site, Investigative Centers, Germany

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Who can participate

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

Inclusion criteria

  • Only patients successfully completing study CLAF237A2309 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion criteria

  • Premature discontinuation from CLAF237A2309
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Safety during 104 weeks of treatment

  2. Change from baseline in HbA1c at 104 weeks

Secondary outcomes

  1. Change in HbA1c between 52 weeks and 104 weeks

  2. Change in fasting plasma glucose between 52 weeks and 104 weeks

  3. Change from baseline in fasting plasma glucose at 104 weeks

  4. Change from baseline in HOMA B at 104 weeks

  5. Change in HOMA B between 52 weeks and 104 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 30, 2005
Registry last updated
Nov 18, 2016

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.

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