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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Glimepiride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Handok Pharmaceuticals Co., Ltd.

Official(s) and/or principal investigator(s):
Hyou-Young Rhim, Study Director, Affiliation: Handok Pharmaceuticals Co., Ltd.

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: 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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Efficacy : Change in HbA1c between baseline and endpoint

Secondary outcome:

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

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Handok, Seoul, Korea, Republic of

Starting date: August 2006
Ending date: July 2007
Last updated: November 28, 2007