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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004802-13 | EudraCT Number | ||
| U1111-1163-5039 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DV3316 pen-injector | Experimental |
| |
| FlexPen® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlexPen® | Device | For subcutaneously (s.c. under the skin) injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Injection success (full dose delivered s.c.) (yes/no) | By assessment that the dose counter has returned to "0" (EoD confirmation) for the DV3316 pen-injector and for FlexPen® at least 6 seconds after the dose counter has returned to "0" |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' confidence in injection completion (delivery of correct, full dose) | Injection completed within 2 minutes after needle insertion | |
| Amount of liquid on the skin (placebo solution or tissue fluid) | Injection completed within 2 minutes after needle insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29369494 | Result | Tang H, Li G, Zhao Y, Wang F, Gower EW, Shi L, Wang T. Comparisons of diabetic retinopathy events associated with glucose-lowering drugs in patients with type 2 diabetes mellitus: A network meta-analysis. Diabetes Obes Metab. 2018 May;20(5):1262-1279. doi: 10.1111/dom.13232. Epub 2018 Feb 23. | |
| 29369493 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| DV3316 pen-injector |
| Device |
For subcutaneously (s.c. under the skin) injection. |
|
| placebo | Drug | For subcutaneously (s.c. under the skin) injection |
|
| Subjects' reaction time | Injection completed within 2 minutes after needle insertion |
| Subjects evaluation of pen-injector experience | Injections completed within 2 minutes of needle insertion |
| Number of technical complaints | Day 1 |
| Number of adverse device effects | Day 1 |
| Grading of bleeding, redness, bruising and swelling at the site of injection | Within 10 minutes after completion of injection |
| Grading of bleeding, redness, bruising and swelling at the site of injection | 1 hour after completion of injection |
| Neuss |
| 41460 |
| Germany |
| Zijlstra E, Coester HV, Heise T, Plum-Morschel L, Rasmussen O, Rikte T, Pedersen LK, Qvist M, Sparre T. Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism. Diabetes Obes Metab. 2018 May;20(5):1140-1147. doi: 10.1111/dom.13203. Epub 2018 Jan 25. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |