A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®

Study Overview
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Brief Summary
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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®.

Official Title
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A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: FlexPen®
* Device: DV3316 pen-injector
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DV3316 pen-injector<br> | Device: DV3316 pen-injector<br>* For subcutaneously (s.c. under the skin) injection.<br>Drug: placebo<br>* For subcutaneously (s.c. under the skin) injection<br>|
| Active Comparator: FlexPen®<br> | Device: FlexPen®<br>* For subcutaneously (s.c. under the skin) injection.<br>Drug: placebo<br>* For subcutaneously (s.c. under the skin) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |