Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of Amaryl®M 1/500 mg twice daily versus Amaryl® 4 mg both in combination with Lantus® once-daily regimen in type 2 Diabetes Mellitus patients with inadequate glycemic control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Glimepiride; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Patients over 20 years old with type 2 DM

• Patients with inadequate glycemic control despite continuous use of tolerable or maximal doses of one or more OADs for 3months or more.

• 7%- 21 kg/m2 ≤ BMI ≤ 30 kg/m2

• Patents who need insulin add-on therapy based on investigator's discretion

• Patients who would give the informed consent

• Patients who can perform SMBG and record the data on the patient's diary

Exclusion Criteria:

• History of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening

• Pregnant or lactating females

• History of drug or alcohol abuse

• Patients with known hypersensitivity to glimepiride, metformin HCL or insulin

• Night-shift workers

• Patients who are under insulin therapy at screening

• Treatment with any investigational products in the last 3 months before screening

• Clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision

• Patients with serum creatinine level > 1.5 mg/dl in male and > 1.4 mg/dl in female

• Patients with ALT or AST > 3x ULN