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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Open, Randomized, Parallel-group, 2 Arm Study to Compare the Efficacy and Safety of Amaryl®M 1/500mg Twice Daily Versus Amaryl® 4mg Both in Combination With Lantus® Once-daily Regimen in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: glimepiride + insulin glargine (Amaryl + Lantus)
* Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amaryl group<br> | Drug: glimepiride + insulin glargine (Amaryl + Lantus)<br>* Amaryl® 4 mg at breakfast + Lantus® at dinner The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast<br>* Other names: Lantus injection solostar;|
| Experimental: Amaryl M group<br> | Drug: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)<br>* Amaryl® M 1/500 mg at breakfast + Amaryl® M 1/500 mg at dinner + Lantus® at dinner The initial dose of Lantus® is 0.2IU/kg at baseline. Lantus® titration will be made by patients every 3 days based on the mean value of previous 3 fasting SMBG level before breakfast<br>* Other names: Lantus injection solostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c from baseline to the last visit |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events |  | 16 weeks | 
| Response rate based on HbA1c and FPG levels measured at the last visit |  | 16 weeks | 
| Mean change in Lantus® dose from baseline to the last visit |  | 16 weeks | 
| Compliance |  | 16 weeks | 
| Frequency with hypoglycemic episode |  | 16weeks | 
| Adverse events |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus