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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014