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

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00437554
First received: February 20, 2007
Last updated: November 28, 2007
Last verified: November 2007
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Glimepiride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Efficacy : Change in HbA1c between baseline and endpoint

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 188
Study Start Date: August 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437554

Locations
Korea, Republic of
Handok
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Study Director: Hyou-Young Rhim Handok Pharmaceuticals Co., Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00437554     History of Changes
Other Study ID Numbers: GLIME_L_01019
Study First Received: February 20, 2007
Last Updated: November 28, 2007
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014