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Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

NCT00612144 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2013-03-28

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.

Conditions

Interventions

DRUG

Glimepiride/metformin fixed combination

Amaryl M 1/250mg\~4/1000mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG

DRUG

Metformin HCl

Metformin HCl 500mg\~1250mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG

Sponsors & Collaborators

  • Handok Inc.

    lead INDUSTRY

Principal Investigators

  • Dong Seob CHOI · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT00612144 on ClinicalTrials.gov