Status:
COMPLETED
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)
Lead Sponsor:
Handok Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
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 glim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00437554
Start Date
August 1 2006
End Date
July 1 2007
Last Update
November 29 2007
Active Locations (1)
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1
Handok
Seoul, South Korea