Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.
Interventions
DEVICEFlexPen®
For subcutaneously (s.c. under the skin) injection.
DEVICEDV3316 pen-injector
For subcutaneously (s.c. under the skin) injection.
DRUGplacebo
For subcutaneously (s.c. under the skin) injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-74 years (both included) at the time of signing informed consent * T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) (as diagnosed clinically) at least 12 months prior to screening * Daily self-injection(s) with anti-diabetic drug (insulin or Glucagon-Like Peptide-1 (GLP- 1) analogues) in pen-injector or vial/syringe for at least 12 months * Caucasians * Body Mass Index (BMI) at least 18.5 kg/m\^2
Exclusion criteria
* Known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo) * Female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) * Known urticaria factitive or abnormal reactions to mechanical trauma * Haemophilia and any diseases affecting blood coagulation * Anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit * Intake of any pain-relieving or analgesic drugs on the day of the site visit * Skin diseases and infections of the skin in the injection site areas (abdomen and thighs) * Lipodystrophia in the injection site areas (abdomen and thighs)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Amount of liquid on the skin (placebo solution or tissue fluid) | Injection completed within 2 minutes after needle insertion |
| 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 |
| Subjects' confidence in injection completion (delivery of correct, full dose) | Injection completed within 2 minutes after needle insertion |
| 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 |
| Number of technical complaints | Day 1 |
Countries
Germany
Outcome results
None listed