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OpenTrials
Completed

NCT Number: NCT00110240

Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose 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.

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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 Pharmaceuticals

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 20-40
  • Blood glucose criteria must be met

Exclusion criteria

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular conditions
  • 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 HbA1c at 24 weeks for subset of Chinese patients

  2. Overall adverse event profile after 24 weeks of treatment

  3. Gastrointestinal side effect profiles after 24 weeks of treatment

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

  5. Patients with endpoint HbA1c <7% after 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 5, 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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