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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004045-33 | EudraCT Number |
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This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imeglimin (Dose 1) | Experimental |
| |
| Imeglimin (Dose 2) | Experimental |
| |
| Imeglimin (Dose 3) | Experimental |
| |
| Imeglimin (Dose 4) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imeglimin | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Baseline and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG) | Baseline to week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valdis Pirags, MD | P. Stradins Clinical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
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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 |
|---|---|
| C575881 | imeglimin |
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| Placebo |
| Drug |
|
| D004700 | Endocrine System Diseases |