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

Handok

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00437554

GLIME_L_01019

Details and patient eligibility

About

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

Enrollment

188 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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;