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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Metformin

vildagliptin

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes;, vildagliptin;, metformin;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

metformin up titration

vildagliptin add on to metformin

Arm Description

metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)

Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01541956

First Posted

February 24, 2012

Last Updated

November 16, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01541956

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

type 2 diabetes;, vildagliptin;, metformin;

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3091 (Actual)

8. Arms, Groups, and Interventions

Arm Title

metformin up titration

Arm Type

Active Comparator

Arm Description

metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)

Arm Title

vildagliptin add on to metformin

Arm Type

Experimental

Arm Description

Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

500 mg twice daily

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Other Intervention Name(s)

LAF237

Intervention Description

Vildagliptin 50 mg twice daily

Primary Outcome Measure Information:

Title

Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin

Description

Time Frame

baseline, 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups

Description

Time Frame

baseline and 24 weeks

Title

Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%

Description

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.

Time Frame

baseline and 24 weeks

Title

Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events

Description

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.

Time Frame

baseline and 24 weeks

Title

Mean change from baseline in fasting plasma glucose (FPG)

Description

Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.

Time Frame

baseline, 24 weeks

Title

Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample

Description

Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.

Time Frame

baseline, 24 weeks

Title

Number of patients with adverse events, serious adverse events and death

Description

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100028

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

27406394

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.

Results Reference

result

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

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