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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes
InterventionDrug: Metformin
Drug: vildagliptin
PhasePhase 4
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT01541956
First ReceivedFebruary 24, 2012
Last UpdatedJanuary 14, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 24, 2012
Last Updated DateJanuary 14, 2014
Start DateFebruary 2012
Estimated Primary Completion DateDecember 2013
Current Primary Outcome MeasuresChange from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin [Time Frame: baseline, 24 weeks] [Designated as safety issue: No]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
Current Secondary Outcome Measures
  • Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups [Time Frame: baseline and 24 weeks] [Designated as safety issue: No]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)
  • Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% [Time Frame: baseline and 24 weeks] [Designated as safety issue: No]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.
  • Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events [Time Frame: baseline and 24 weeks] [Designated as safety issue: No]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.
  • Mean change from baseline in fasting plasma glucose (FPG) [Time Frame: baseline, 24 weeks] [Designated as safety issue: No]Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.
  • Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample [Time Frame: baseline, 24 weeks] [Designated as safety issue: No]Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.
  • Number of patients with adverse events, serious adverse events and death [Time Frame: up to 24 weeks] [Designated as safety issue: Yes]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.

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)
Official TitleAn 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 .
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Metformin
500 mg twice daily
Drug: vildagliptin
Vildagliptin 50 mg twice daily
Other Names:
LAF237
Study Arm (s)
  • Active Comparator: metformin up titration
    metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
  • Experimental: vildagliptin add on to metformin
    Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment3091
Estimated Completion DateDecember 2013
Estimated Primary Completion DateDecember 2013
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT01541956
Other Study ID NumbersCLAF237ACN01
Has Data Monitoring CommitteeNo
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Novartis Investigative Site
Beijing, China, 100028