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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02627287
Collaborator
(none)
150
Enrollment
2
Locations
2
Arms
2.8
Actual Duration (Months)
75
Patients Per Site
26.5
Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • Device: FlexPen®
  • Device: DV3316 pen-injector
  • Drug: placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Feb 25, 2016
Actual Study Completion Date :
Feb 25, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: DV3316 pen-injector

Device: DV3316 pen-injector
For subcutaneously (s.c. under the skin) injection.

Drug: placebo
For subcutaneously (s.c. under the skin) injection
Active Comparator: FlexPen®

Device: FlexPen®
For subcutaneously (s.c. under the skin) injection.

Drug: placebo
For subcutaneously (s.c. under the skin) injection

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Subjects' confidence in injection completion (delivery of correct, full dose) [Injection completed within 2 minutes after needle insertion]

  2. Amount of liquid on the skin (placebo solution or tissue fluid) [Injection completed within 2 minutes after needle insertion]

  3. Subjects' reaction time [Injection completed within 2 minutes after needle insertion]

  4. Subjects evaluation of pen-injector experience [Injections completed within 2 minutes of needle insertion]

  5. Number of technical complaints [Day 1]

  6. Number of adverse device effects [Day 1]

  7. Grading of bleeding, redness, bruising and swelling at the site of injection [Within 10 minutes after completion of injection]

  8. Grading of bleeding, redness, bruising and swelling at the site of injection [1 hour after completion of injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Mainz Germany 55116
2 Novo Nordisk Investigational Site Neuss Germany 41460

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02627287
Other Study ID Numbers:
  • INS-4208
  • 2014-004802-13
  • U1111-1163-5039
First Posted:
Dec 10, 2015
Last Update Posted:
Feb 7, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Feb 7, 2018