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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004286-32 | EudraCT Number | ||
| CLAF237ADE06T | Other Identifier | Novartis Pharma GmbH |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| IKFE Institute for Clinical Research and Development | OTHER |
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The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin plus Metformin | Experimental | Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily |
|
| Glimepirid plus Metformin | Active Comparator | Metformin (1000 mg BID) + Glimepiride (individual dosage) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 1000 mg BID |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting intact proinsulin levels | One year | |
| Max postprandial intact proinsulin levels | One year | |
| Retinal endothelial response to flicker light stimulation |
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Inclusion Criteria:
Diabetes mellitus type 2
HbA1c > 6.5%* ≤ 9.5%
* NOTE: Patients with cardiovascular preconditions (Coronary Heart Disease or Myocard Infarction) require an HbA1c > 7.0% ≤ 9.5%
Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator
Age 30 - 80 years
Patient consents that his/her family physician will be informed of trial participation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Forst, Prof. Dr. | Contact | +49 6131 576 36 16 | thomasf@ikfe.de | |
| Swantje Anders | Contact | +49 6131 327 90 22 | s.anders@ikfe-cro.de |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Forst, Prof. Dr. | Ikfe GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ikfe GmbH | Recruiting | Mainz | 55116 | Germany |
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| Drug |
Metformin 1000 mg BID |
|
| Vildagliptin | Drug | Vildagliptin 50 mg twice daily |
|
| Glimepiride | Drug | Glimepiride at individual dose |
|
| One year |
| Mean 24h systolic and diastolic blood pressure | One year |
| Erythrocyte deformability | One year |
| E-selectin | One year |
| Change in body weight | One year |
| hsCRP | One year |
| HbA1c | One year |
| Fasting blood glucose | One year |
| Number of hypoglycemic events | One year |
| Adverse events | One year |
| Drug related adverse events | One year |
| 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 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077597 | Vildagliptin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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