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OpenTrials
Completed

NCT Number: NCT00101673

Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

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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

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

Exclusion criteria

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of serious 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 12 weeks

Secondary outcomes

  1. Adverse event profile after 12 weeks of treatment

  2. Patients with reduction in HbA1c >/= 0.7% after 12 weeks

  3. Change from baseline in fasting plasma glucose at 12 weeks

  4. Change from baseline in HOMA-B at 12 weeks

  5. Change from baseline in body weight at 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
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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