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OpenTrials
Completed

NCT Number: NCT00138606

Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. 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–80 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 CLAF237A2311 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion criteria

  • Premature discontinuation from CLAF237A2311
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Safety of vildagliptin in combination with insulin during 52 weeks of treatment

  2. Change from baseline in HbA1c at 52 weeks

Secondary outcomes

  1. Change in HbA1c between 24 weeks and 52 weeks

  2. Change in fasting plasma glucose between 24 weeks and 52 weeks

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

  4. Change from baseline in mean daily insulin dose at 52 weeks

  5. Change from baseline in mean daily number of insulin injections at 52 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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