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

NCT00437554 | Completed Phase 3

• 1 other identifier: GLIME_L_01019
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Efficacy : Change in HbA1c between baseline and endpoint

Secondary Outcomes (2)

• 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

Interventions

Glimepiride DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hyou-Young Rhim

  Handok Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: August 1, 2006
• Study Completion: July 1, 2007
• Last Updated: November 29, 2007

Record last verified: 2007-11

Locations

KR (1)