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Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy

NCT01565096 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-03-28

No results posted yet for this study

Summary

The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy.

Conditions

  • Diabetes Mellitus Type II

Interventions

DRUG

Metformin

Metformin 1000 mg BID

DRUG

Metformin

Metformin 1000 mg BID

DRUG

Vildagliptin

Vildagliptin 50 mg twice daily

DRUG

Glimepiride

Glimepiride at individual dose

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • IKFE Institute for Clinical Research and Development

    collaborator OTHER

  • ikfe-CRO GmbH

    lead INDUSTRY

Principal Investigators

  • Thomas Forst, Prof. Dr. · Ikfe GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT01565096 on ClinicalTrials.gov