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OpenTrials
Completed

NCT Number: NCT00102388

Efficacy and Safety of Vildagliptin Compared to Gliclazide 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 gliclazide 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 Investigative Site, Investigative Centers, 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

  • Not currently on drug therapy for type 2 diabetes
  • 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 conditions
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

Vildagliptin

Drug

Gliclazide

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 104 weeks

    Time frame: 104 weeks

Secondary outcomes

  1. Adverse event profile at 104 weeks

    Time frame: 104 weeks

  2. Change from baseline in fasting plasma glucose at 104 weeks

    Time frame: 104 weeks

  3. Patients with endpoint HbA1c <7% after 104 weeks

    Time frame: 104 weeks

  4. Patients with reduction in HbA1c >/= 0.7% after 104 weeks

    Time frame: 104 weeks

  5. Patients with reduction in HbA1x >/= 0.5% after 104 weeks

    Time frame: 104 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
First posted
Jan 31, 2005
Registry last updated
Nov 18, 2016

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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