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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Glimepiride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Glimepiride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy : Change in HbA1c between baseline and endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |