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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin; Drug: vildagliptin

• Registration Number: NCT01541956
• Lead Sponsor: Novartis Pharmaceuticals

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 Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3091

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin up titration	Metformin	metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
vildagliptin add on to metformin	Metformin	Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
vildagliptin add on to metformin	vildagliptin	Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin	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 Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups	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)
Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%	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.
Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events	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.
Mean change from baseline in fasting plasma glucose (FPG)	baseline, 24 weeks	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	baseline, 24 weeks	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	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Beijing, China