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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
* 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
* 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
HeeYoung Lee
Seoul, South Korea
Mean change in HbA1c from baseline to the last visit
Time frame: 16 weeks
Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events
Time frame: 16 weeks
Response rate based on HbA1c and FPG levels measured at the last visit
Time frame: 16 weeks
Mean change in Lantus® dose from baseline to the last visit
Time frame: 16 weeks
Compliance
Time frame: 16 weeks
Frequency with hypoglycemic episode
Time frame: 16weeks
Adverse events
Time frame: 16 weeks
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