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OpenTrials
Completed

NCT Number: NCT00237237

Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin 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–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Nuremberg, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • History of type 1 diabetes
  • Pregnancy or lactation
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Laboratory value abnormalities as defined by the protocol
  • Known sensitivity to pioglitazone
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 52 weeks

Secondary outcomes

  1. Adverse event profile after 52 weeks of treatment

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

  3. Change from baseline in body weight at 52 weeks

  4. Patients with endpoint HbA1c < 7% after 52 weeks

  5. Patients with reduction in HbA1c >/= to 7% after 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Primary completion
2007
First posted
Oct 12, 2005
Registry last updated
Feb 7, 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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