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OpenTrials
Completed

NCT Number: NCT00106340

Vildagliptin Compared to Glimepiride 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 glimepiride 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–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Nuremberg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant 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

Other names: LAF237, Galvus

Glimepiride

Drug

metformin

Drug

Vildagliptin matching placebo

Drug

Glimepiride matching placebo

Drug

Primary outcomes

  1. Time to HbA1c >8%

    Time frame: 2 year

Secondary outcomes

  1. Change from baseline in HbA1c at 5 years

    Time frame: 2 years (amended)

  2. Adverse event profile after 5 years of treatment

    Time frame: 2 years (amended)

  3. Coefficient of failure for HbA1c from week 24 to 5 years

    Time frame: 2 years (amended)

  4. Change from baseline in fasting plasma glucose at 5 years

    Time frame: 2 years (amended)

  5. Change from baseline in body weight at 5 years

    Time frame: 2 years (amended)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2005
Registry last updated
Dec 17, 2020

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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