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Primary objective:
To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level
Secondary objective:
To compare the incidence of hypoglycemia in each treatment group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Administration of 4 mg of Glimepiride with Insulin Glargine |
|
| 2 | Active Comparator | Administration of 1500 mg of Metformin with Insulin Glargine |
|
| 3 | Experimental | Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride | Drug | Once a day before breakfast |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c values | At baseline to end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia events | From inclusion to end of study | |
| Percentage of patients with HbA1c < 7% | At the end of the study | |
| Fasting Blood Glucose level |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Ji Young Ahn | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24614911 | Derived | Park CY, Kang JG, Chon S, Noh J, Oh SJ, Lee CB, Park SW. Comparison between the therapeutic effect of metformin, glimepiride and their combination as an add-on treatment to insulin glargine in uncontrolled patients with type 2 diabetes. PLoS One. 2014 Mar 10;9(3):e87799. doi: 10.1371/journal.pone.0087799. eCollection 2014. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
| D008687 | Metformin |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D049528 |
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| Drug |
After breakfast and supper |
|
| Insulin Glargine | Drug | Injection in the morning |
|
| At the end of the study |
| D004700 | Endocrine System Diseases |
| 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 |