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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Device: DV3316 pen-injector; Device: FlexPen®; Drug: placebo

• Registration Number: NCT02627287
• Lead Sponsor: Novo Nordisk A/S

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-27
• Study Start: 2015-12-01
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-10
• Primary Completion: 2016-02-25
• Study Completion: 2016-02-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FlexPen®	placebo	-
DV3316 pen-injector	DV3316 pen-injector	-
FlexPen®	FlexPen®	-
DV3316 pen-injector	placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Subjects' reaction time	Injection completed within 2 minutes after needle insertion
Subjects' confidence in injection completion (delivery of correct, full dose)	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
Amount of liquid on the skin (placebo solution or tissue fluid)	Injection completed within 2 minutes after needle insertion
Grading of bleeding, redness, bruising and swelling at the site of injection	1 hour after completion of injection

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany