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

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin; Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541956

CLAF237ACN01

Details and patient eligibility

About

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.

Enrollment: 3,091 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,091 participants in 2 patient groups

metformin up titration

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

vildagliptin add on to metformin

Experimental group

Description:

Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Treatment:

Drug: Metformin

Drug: vildagliptin