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OpenTrials
Completed

NCT Number: NCT00351884

Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

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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–78 year

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

  • Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Body mass index in the range 22-40
  • Blood glucose criteria must be met

Exclusion criteria

  • Pregnancy or lactation
  • History of type 1 diabetes
  • Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin AM

Drug

vildagliptin pm

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in HbA1c at 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Safety of vildagliptin in combination with metformin during 24 weeks of treatment

    Time frame: 24 weeks

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

  4. Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks

    Time frame: 24 weeks

  5. Change from baseline in body weight at 24 weeks

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Important dates

Study start
2006
Primary completion
2007
First posted
Jul 13, 2006
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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