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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002508-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck, S.L., Spain | INDUSTRY |
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This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucophage sachets | Experimental | Patients receive Glucophage sachets, the powder formulation for oral solution in sachets. |
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| Glucophage tablets | Active Comparator | Patients received Glucophage tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucophage | Drug | Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6 | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective compliance to treatment | Objective compliance to treatment is assessed by the accountability of medication returned. Patient is assessed as compliant with an adherence of over 80%. | Month 3 and month 6 |
| Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck, S.L., Spain | Study Director |
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| Glucophage | Drug | Glucophage tablets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month |
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| Baseline, month 3 and month 6 |
| Rate of reported adverse events | Month 3 and month 6 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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