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Completed

NCT Number: NCT01159249

Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Hunabashi, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or α-GI, or glinides monotherapy
  • Age in the 20 years or over inclusive
  • HbA1c in the range of ≥ 6.5 to ≤ 10%

Exclusion criteria

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications

Treatment and study plan

Vildagliptin

Drug

Primary outcomes

  1. Measure AEs, vital signs, laboratory evaluations

    Time frame: 52 weeks

Secondary outcomes

  1. HBA1c

    Time frame: 52 weeks

  2. Fasting Plasma Glucose

    Time frame: 52 weeks

  3. Fasting Insulin

    Time frame: 52 weeks

  4. Fasting C-peptide

    Time frame: 52 weeks

  5. HOMA-B

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 9, 2010
Registry last updated
Dec 17, 2020

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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