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

February 6, 2018 updated by: Novo Nordisk A/S

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

This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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®
Drug: placebo
For subcutaneously (s.c. under the skin) injection
Device: FlexPen®
For subcutaneously (s.c. under the skin) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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"
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
Time Frame
Subjects' confidence in injection completion (delivery of correct, full dose)
Time Frame: Injection completed within 2 minutes after needle insertion
Injection completed within 2 minutes after needle insertion
Amount of liquid on the skin (placebo solution or tissue fluid)
Time Frame: Injection completed within 2 minutes after needle insertion
Injection completed within 2 minutes after needle insertion
Subjects' reaction time
Time Frame: Injection completed within 2 minutes after needle insertion
Injection completed within 2 minutes after needle insertion
Subjects evaluation of pen-injector experience
Time Frame: Injections completed within 2 minutes of needle insertion
Injections completed within 2 minutes of needle insertion
Number of technical complaints
Time Frame: Day 1
Day 1
Number of adverse device effects
Time Frame: Day 1
Day 1
Grading of bleeding, redness, bruising and swelling at the site of injection
Time Frame: Within 10 minutes after completion of injection
Within 10 minutes after completion of injection
Grading of bleeding, redness, bruising and swelling at the site of injection
Time Frame: 1 hour after completion of injection
1 hour after completion of injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

February 25, 2016

Study Completion (Actual)

February 25, 2016

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-4208
  • 2014-004802-13 (EudraCT Number)
  • U1111-1163-5039 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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