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OpenTrials
Completed

NCT Number: NCT00099931

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. The purpose of this study is 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.

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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 Sites, Germany

Who can participate

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

Inclusion criteria

  • Blood glucose criteria must be met
  • On a stable dose of insulin as defined by the protocol
  • Body mass inde (BMI) in the range 22-45

Exclusion criteria

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

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 24 weeks

Secondary outcomes

  1. Change from baseline in fasting plasma glucose at 24 weeks

  2. Adverse event profile after 24 weeks of treatment

  3. Change from baseline in mean daily insulin dose at 24 weeks

  4. Change from baseline in mean daily number of insulin injections at 24 weeks

  5. Patients with endpoint <7% after 24 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.

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