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

November 28, 2007 updated by: Handok Inc.

A 16-Week Controlled, Double Blind, Double Dummy, Randomized, Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1/250 mg b.i.d vs. Amaryl M SR 2/500 mg od. in Patients With Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with type 2 DM diagnosed for at least 3 months but no longer than 10 years before screening;
  • - BMI ≤ 40 kg/m²;
  • A negative pregnancy test for all females of childbearing potential

Exclusion Criteria:

  • A history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
  • Current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
  • Concomitant treatment prohibited during the study period;
  • Any oral anti-diabetic drugs other than study medication
  • Any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
  • Intermittent use of systemic corticosteroids or large dose of inhaled steroids
  • Subjects with clinically significant renal (serum creatinine level >1.5 mg/dL in male and >1.4 mg/dL in female) or hepatic disease (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2x upper limit of normal (ULN));
  • Subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
  • Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
  • Pregnant or lactating females;
  • History of drug or alcohol abuse;
  • Subjects with known hypersensitivity to glimepirides, or metformin; Night-shift workers;
  • Treatment with any investigational product in the last 3 months before study entry;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy : Change in HbA1c between baseline and endpoint

Secondary Outcome Measures

Outcome Measure
Efficacy : Change in HbA1c measured at baseline, week 8 and week 16. Change in FPG and PP2h measured at baseline, week 8 and week 16. 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, Frequency with hypoglycemic episode

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Investigators

  • Study Director: Hyou-Young Rhim, Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 29, 2007

Last Update Submitted That Met QC Criteria

November 28, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIME_L_01019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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