Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amaryl group | Active Comparator |
| |
| Amaryl M group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glimepiride + insulin glargine (Amaryl + Lantus) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in HbA1c from baseline to the last visit | 16 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kang S Park | Eulji University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HeeYoung Lee | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus) | Drug |
|
|
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C057619 | glimepiride |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided