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

Handok

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: glimepiride + insulin glargine (Amaryl + Lantus)

Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00913367

HANDOK2008.10

Details and patient eligibility

About

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.

Full 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. However, as the beta cell dysfunction progresses over time, patients fail to achieve good glycemic control with OADs alone and need further treatment intensification, usually involving the introduction of insulin either alone or in combination with OADs. Now, an OAD combined with bedtime insulin is one of the recommended treatment options for patients with type 2 DM and OAD failure. But, it still remains unclear which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

so, this study we will be able to verify which OADs are the most effective in combination with insulin for the treatment of type 2 DM.

Enrollment

110 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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%<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 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