Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGGlimepiride
Sponsors
Handok Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy : Change in HbA1c between baseline and endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
South Korea
Outcome results
None listed