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OpenTrials
Completed

NCT Number: NCT00101712

Efficacy and Safety of Vildagliptin Compared to Placebo in 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 assess the 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Investigative Site, 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

  • Blood glucose criteria must be met
  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion criteria

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

Treatment and study plan

Vildagliptin

Drug

Other names: LAF237

Vildagliptin Placebo

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 52 weeks

Secondary outcomes

  1. Adverse event profile after 52 weeks of treatment

  2. Patients with HbA1c <6.5% at 12 weeks

  3. Patients with HbA1c <6.5% at 52 weeks

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

  5. Coefficient of failure for HbA1c between 24 weeks and 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 13, 2005
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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