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

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ClinicalTrials.gov Identifier: NCT02627287
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
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®.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Device: FlexPen® Device: DV3316 pen-injector Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
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 : December 1, 2015
Actual Primary Completion Date : February 25, 2016
Actual Study Completion Date : February 25, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Injection success (full dose delivered s.c.) (yes/no) [ Time Frame: 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) [ Time Frame: Injection completed within 2 minutes after needle insertion ]
  2. Amount of liquid on the skin (placebo solution or tissue fluid) [ Time Frame: Injection completed within 2 minutes after needle insertion ]
  3. Subjects' reaction time [ Time Frame: Injection completed within 2 minutes after needle insertion ]
  4. Subjects evaluation of pen-injector experience [ Time Frame: Injections completed within 2 minutes of needle insertion ]
  5. Number of technical complaints [ Time Frame: Day 1 ]
  6. Number of adverse device effects [ Time Frame: Day 1 ]
  7. Grading of bleeding, redness, bruising and swelling at the site of injection [ Time Frame: Within 10 minutes after completion of injection ]
  8. Grading of bleeding, redness, bruising and swelling at the site of injection [ Time Frame: 1 hour after completion of injection ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627287


Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55116
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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02627287     History of Changes
Other Study ID Numbers: INS-4208
2014-004802-13 ( EudraCT Number )
U1111-1163-5039 ( Other Identifier: WHO )
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases