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OpenTrials
Completed

NCT Number: NCT00138554

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

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. 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 pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone 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 Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

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

Inclusion criteria

  • Only patients successfully completing study CLAF237A2304 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion criteria

  • Premature discontinuation from study CLAF237A2304
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

pioglitazone

Drug

pioglitazone 45 mg qd

Primary outcomes

  1. Safety of vildagliptin in combination with pioglitazone 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 from baseline in fasting plasma glucose at 52 weeks

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

  4. Change from baseline in HOMA B at 52 weeks

  5. Change from baseline in HOMA IR at 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 30, 2005
Registry last updated
Feb 23, 2017

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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