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

NCT01541956 | Completed Phase 4

• 1 other identifier: CLAF237ACN01
• Study Type: interventional
• Target: 3,091
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes;; vildagliptin;; metformin;

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

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

  baseline and 24 weeks

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

  baseline and 24 weeks

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

  baseline and 24 weeks

• Mean change from baseline in fasting plasma glucose (FPG)

  baseline, 24 weeks

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

  baseline, 24 weeks

Study Arms (2)

metformin up titration

ACTIVE COMPARATOR

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

Drug: Metformin

vildagliptin add on to metformin

EXPERIMENTAL

Vildagliptin 50 mg twice daily + Metformin 500mg twice daily

Drug: Metformin; Drug: vildagliptin

Interventions

Metformin DRUG

500 mg twice daily

metformin up titration; vildagliptin add on to metformin

vildagliptin DRUG

Vildagliptin 50 mg twice daily

Also known as: LAF237

vildagliptin add on to metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese T2D patients who are inadequate controlled (6.5 %\< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Beijing, 100028, China

Location

Related 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 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.

  PMID: 27406394 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Vildagliptin; 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 1, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CN (1)