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OpenTrials
Completed

NCT Number: NCT00300287

A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Sites, Germany

Who can participate

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

Inclusion criteria

  • Completion of study CLAF237A2307 within 4 weeks of entering into the extension
  • Written informed consent
  • Ability to comply with all study requirements
  • Blood glucose criteria must be met

Exclusion criteria

  • Premature discontinuation from study CLAF237A2307

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 108 weeks

Secondary outcomes

  1. Adverse event profile after 108 weeks of treatment

  2. Change in HbA1c from week 52 to week 108

  3. Change from baseline in fasting plasma glucose at week 108

  4. Change in fasting plasma glucose from week 52 to week 108

  5. Change from baseline in body weight at week 108

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 8, 2006
Registry last updated
Aug 2, 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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