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

Type 2 Diabetes Clinical Trial

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541956
• Other study ID #: CLAF237ACN01
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2012
• Last updated: November 16, 2016
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3091
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Metformin
500 mg twice daily
• vildagliptin
Vildagliptin 50 mg twice daily

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin	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	baseline, 24 weeks	No
Secondary	Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups	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)	baseline and 24 weeks	No
Secondary	Percentage of patients achieving target hemoglobin A1c( HbA1C) of =6.5%	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.	baseline and 24 weeks	No
Secondary	Percentage of patients achieving target hemoglobin A1c(HbA1C) of =6.5% without adverse gastrointestinal (GI) events	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.	baseline and 24 weeks	No
Secondary	Mean change from baseline in fasting plasma glucose (FPG)	Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.	baseline, 24 weeks	No
Secondary	Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample	Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.	baseline, 24 weeks	No
Secondary	Number of patients with adverse events, serious adverse events and death	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.	up to 24 weeks	Yes

External Links

•   Results for CLAF237ACN01 from the Novartis Clinical Trials website