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VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus

NCT01528254 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2004

Last updated 2020-09-24

Study results available
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Summary

The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).

Conditions

Interventions

DRUG

Placebo of vildagliptin

DRUG

vildagliptin

One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.

DRUG

Metformin

Twice daily (bid) regimen during or after meals at the same time as vildagliptin.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-30
Primary Completion
2019-04-04
Completion
2019-04-04

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Dominican Republic
  • Estonia
  • Finland
  • Germany
  • Guatemala
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528254 on ClinicalTrials.gov