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Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)

NCT00437554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2007-11-29

No results posted yet for this study

Summary

Primary:

To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM)

Secondary: To compare the following parameters in two treatment arm

* Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h)
* Response rates in terms of HbA1c, FPG
* Patient compliance

Safety:

* episodes of hypoglycemia
* adverse events
* laboratory values including hematology blood chemistry and urinalysis
* vital sign and physical examination

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Glimepiride

Sponsors & Collaborators

  • Handok Inc.

    lead INDUSTRY

Principal Investigators

  • Hyou-Young Rhim · Handok Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Completion
2007-07-31

Countries

  • South Korea

Study Locations

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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 NCT00437554 on ClinicalTrials.gov