Status:
COMPLETED
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
Lead Sponsor:
Handok Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
There are several kinds of oral antidiabetic drugs (OADs) that are used in the treatment of patients with type 2 DM. Among them, sulfonylurea and metformin are well-established first-line OADs. Howeve...
Eligibility Criteria
Inclusion
- 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%\<HbA1c\<11 % at screening
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00913367
Start Date
May 1 2009
End Date
November 1 2010
Last Update
March 28 2013
Active Locations (1)
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1
HeeYoung Lee
Seoul, South Korea