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Primary objective:
Secondary objectives:
Safety:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lantus once a day plus Glucophage 1000mg, twice a day per os |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lantus (insulin glargine) + Glucophage (Metformin) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal). | During the study conduct |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the predictive criterion of HbA1c final | During the study conduct | |
| Determination of the predictive criterion of weight variation | During all the study conduct | |
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Inclusion Criteria:
Known type 2 diabetes for at least 2 years
No history of Ketoacidosis
BMI> 25 & <35 kg/m2
Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
HbA1c >= 7.5 and <11% for 2 different dosages during the last year
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Billon | Sanofi-aventis administrative office France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-aventis administrative office | Paris | France |
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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 |
|---|---|
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| HbA1c and weight variations (final value - basal value) |
| during the study |
| AE/SAE evaluation | from the informed consent signed up to the end of the study |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |