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
  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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Metformin
Drug: vildagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 .

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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


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.


Enrollment: 3091
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin up titration
metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
Drug: Metformin
500 mg twice daily
Experimental: vildagliptin add on to metformin
Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
Drug: Metformin
500 mg twice daily
Drug: vildagliptin
Vildagliptin 50 mg twice daily
Other Name: LAF237

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541956

Locations
China
Novartis Investigative Site
Beijing, China, 100028
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01541956     History of Changes
Other Study ID Numbers: CLAF237ACN01
Study First Received: February 24, 2012
Last Updated: January 14, 2014
Health Authority: China: Ethics Committee

Keywords provided by Novartis:
type 2 diabetes;
vildagliptin;
metformin;

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014