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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)

NCT ID: NCT01541956

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3091 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Keywords

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type 2 diabetes; vildagliptin; metformin;

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin up titration

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

500 mg twice daily

vildagliptin add on to metformin

Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

500 mg twice daily

vildagliptin

Intervention Type DRUG

Vildagliptin 50 mg twice daily

Interventions

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Metformin

500 mg twice daily

Intervention Type DRUG

vildagliptin

Vildagliptin 50 mg twice daily

Intervention Type DRUG

Other Intervention Names

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LAF237

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 27406394 (View on PubMed)

Other Identifiers

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CLAF237ACN01

Identifier Type: -

Identifier Source: org_study_id