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| Name | Class |
|---|---|
| Artsana S.p.a. | INDUSTRY |
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The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insupen G34x3,5mm | Experimental | Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge |
|
| Insupen G32x4mm | Active Comparator | Needle for insulin pen 4 mm long and with a diameter of 32 gauge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insupen G34x3,5mm | Device |
| ||
| Insupen G32x4mm |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine levels | Change from baseline in fructosamine levels after 3 weeks of treatment | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels | Change from baseline in glycemic variability after 3 weeks of treatment | 3 weeks |
| Daily insulin dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Nicolucci, MD | Contact | +39 085 9047114 | nicolucci@coresearch.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio | Recruiting | Treviglio | BG | 24047 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29924641 | Derived | De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, D'Angelo P, Fontana L, Lancione R, Marelli G, Sciangula L, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 34G x 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study. Curr Med Res Opin. 2018 Sep;34(9):1699-1704. doi: 10.1080/03007995.2018.1491396. Epub 2018 Jul 5. |
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| ID | Term |
|---|---|
| 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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Change from baseline in daily insulin dose after 3 weeks of treatment
| 3 weeks |
| Body weight | Change from baseline in body weight after 3 weeks of treatment | 3 weeks |
| Pain | Pain measured by visual analogue scale after 3 weeks of treatment | 3 weeks |
| Patient satisfaction measured by a questionnaire | Patient satisfaction measured by a questionnaire after 3 weeks of treatment | 3 weeks |
| Number of patients with hypoglycaemia | Number of patients with hypoglycaemia during 3 weeks | 3 weeks |
| Number of hypoglycaemia episodes | Total number of phypoglycaemia episodes during 3 weeks | 3 weeks |
| Number of episodes of insulin leakage at injection site | Number of episodes of insulin leakage at injection site during 3 weeks of treatment | 3 weeks |
| Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù | Recruiting | Mariano Comense | CO | Italy |
|
| Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate | Recruiting | Desio | MI | Italy |
|
| Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini | Recruiting | Roma | RM | 00157 | Italy |
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