Clinical trial NCT02627287: A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
Official title: A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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®.


Eligibility criteria: 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)

Primary outcomes:
measure: Injection success (full dose delivered s.c.) (yes/no)
timeFrame: 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 outcomes:
measure: Subjects' confidence in injection completion (delivery of correct, full dose)
timeFrame: Injection completed within 2 minutes after needle insertion
measure: Amount of liquid on the skin (placebo solution or tissue fluid)
timeFrame: Injection completed within 2 minutes after needle insertion
measure: Subjects' reaction time
timeFrame: Injection completed within 2 minutes after needle insertion
measure: Subjects evaluation of pen-injector experience
timeFrame: Injections completed within 2 minutes of needle insertion
measure: Number of technical complaints
timeFrame: Day 1
measure: Number of adverse device effects
timeFrame: Day 1
measure: Grading of bleeding, redness, bruising and swelling at the site of injection
timeFrame: Within 10 minutes after completion of injection
measure: Grading of bleeding, redness, bruising and swelling at the site of injection
timeFrame: 1 hour after completion of injection
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.