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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01541956
First received: February 24, 2012
Last updated: January 14, 2014
Last verified: January 2014

February 24, 2012
January 14, 2014
February 2012
December 2013   (final data collection date for primary outcome measure)
Change 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
Same as current
Complete list of historical versions of study NCT01541956 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 frombaseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analysed in pre-defined patient subgroups based on Body Mass Index(BMI) ( <24, ≥ 24) and age (<60 y and ≥ 60 y)
  • Percentage of patients achieving targethemoglobin 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 gastro intentinal (GI) events [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
    The percentage of patients achieving targethemoglobin 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-hourpost 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.
Not Provided
Not Provided
 
Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)
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 .

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Metformin
    500 mg twice daily
  • Drug: vildagliptin
    Vildagliptin 50 mg twice daily
    Other Name: LAF237
  • Active Comparator: metformin up titration
    metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
    Intervention: Drug: Metformin
  • Experimental: vildagliptin add on to metformin
    Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
    Interventions:
    • Drug: Metformin
    • Drug: vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3091
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01541956
CLAF237ACN01
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP