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Completed

NCT Number: NCT00822211

Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 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

China-Japan Friendship Hospital, Beijing, China

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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 T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Agreement to maintain the same dose of metformin from randomization to the end of the study
  • Age in the range of 18-78 years inclusive
  • Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
  • HbA1c in the range of > 7.0 to ≤10% at Visit 1
  • Agreement to maintain prior diet and exercise habits during the full course of the study
  • Ability to comply with all study requirements

Exclusion criteria

  • Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Vildagliptin 50 mg bid

Drug

Vildagliptin 50 mg qd

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in HbA1c after 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Percent of patients with HbA1c < 7% after 24 weeks

    Time frame: 24 weeks

  2. Adverse event profile after 24 weeks of treatment

    Time frame: 24 weeks

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

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
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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