Clinical trial NCT01541956: Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)
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 .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes;
vildagliptin;
metformin;
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 3091
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
timeFrame: baseline, 24 weeks
Secondary outcomes:
measure: Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups
timeFrame: baseline and 24 weeks
measure: Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%
timeFrame: baseline and 24 weeks
measure: Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events
timeFrame: baseline and 24 weeks
measure: Mean change from baseline in fasting plasma glucose (FPG)
timeFrame: baseline, 24 weeks
measure: Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample
timeFrame: baseline, 24 weeks
measure: Number of patients with adverse events, serious adverse events and death
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ji LN, Pan CY, Lu JM, Li H, Zhu DL, Li Q, Li QF, Peng YD, Tian HM, Yao C, Zhao ZG, Wang L, Wang BH; VISION Study Group. Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION). Diabetes Obes Metab. 2016 Aug;18(8):775-82. doi: 10.1111/dom.12667. Epub 2016 May 18.