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Completed

NCT Number: NCT01541956

Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Beijing, 100028, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),

Exclusion criteria

  • Type 1 diabetes and secondary diabetes
  • Acute metabolic diabetic complications within the past 3 months.
  • Acute infections which may influence glucose level.
  • Evidence of significant chronic diabetic complications,
  • Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
  • FPG > 270 mg/dl (15 mmol/l)
  • Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

metformin

Drug

500 mg twice daily

Vildagliptin

Drug

Vildagliptin 50 mg twice daily

Other names: LAF237

Primary outcomes

  1. Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin

    Time frame: baseline, 24 weeks

    The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks

Secondary outcomes

  1. Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups

    Time frame: baseline and 24 weeks

    The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( <24, ≥ 24) and age (<60 y and ≥ 60 y)

  2. Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%

    Time frame: baseline and 24 weeks

    The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups.

  3. Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events

    Time frame: baseline and 24 weeks

    The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups.

  4. Mean change from baseline in fasting plasma glucose (FPG)

    Time frame: baseline, 24 weeks

    Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.

  5. Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample

    Time frame: baseline, 24 weeks

    Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.

  6. Number of patients with adverse events, serious adverse events and death

    Time frame: up to 24 weeks

    Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2012
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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