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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
FlexPen®
DV3316 pen-injector
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DV3316 pen-injector

FlexPen®

Arm Description

Outcomes

Primary Outcome Measures

Injection success (full dose delivered s.c.) (yes/no)

Secondary Outcome Measures

Subjects' confidence in injection completion (delivery of correct, full dose)
Amount of liquid on the skin (placebo solution or tissue fluid)
Subjects' reaction time
Subjects evaluation of pen-injector experience
Number of technical complaints
Number of adverse device effects
Grading of bleeding, redness, bruising and swelling at the site of injection
Grading of bleeding, redness, bruising and swelling at the site of injection

Full Information

First Posted
November 27, 2015
Last Updated
February 6, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02627287
Brief Title
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
Official Title
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
February 25, 2016 (Actual)
Study Completion Date
February 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DV3316 pen-injector
Arm Type
Experimental
Arm Title
FlexPen®
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
FlexPen®
Intervention Description
For subcutaneously (s.c. under the skin) injection.
Intervention Type
Device
Intervention Name(s)
DV3316 pen-injector
Intervention Description
For subcutaneously (s.c. under the skin) injection.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
For subcutaneously (s.c. under the skin) injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Subjects' confidence in injection completion (delivery of correct, full dose)
Time Frame
Injection completed within 2 minutes after needle insertion
Title
Amount of liquid on the skin (placebo solution or tissue fluid)
Time Frame
Injection completed within 2 minutes after needle insertion
Title
Subjects' reaction time
Time Frame
Injection completed within 2 minutes after needle insertion
Title
Subjects evaluation of pen-injector experience
Time Frame
Injections completed within 2 minutes of needle insertion
Title
Number of technical complaints
Time Frame
Day 1
Title
Number of adverse device effects
Time Frame
Day 1
Title
Grading of bleeding, redness, bruising and swelling at the site of injection
Time Frame
Within 10 minutes after completion of injection
Title
Grading of bleeding, redness, bruising and swelling at the site of injection
Time Frame
1 hour after completion of injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29369494
Citation
Tang H, Li G, Zhao Y, Wang F, Gower EW, Shi L, Wang T. Comparisons of diabetic retinopathy events associated with glucose-lowering drugs in patients with type 2 diabetes mellitus: A network meta-analysis. Diabetes Obes Metab. 2018 May;20(5):1262-1279. doi: 10.1111/dom.13232. Epub 2018 Feb 23.
Results Reference
result
PubMed Identifier
29369493
Citation
Zijlstra E, Coester HV, Heise T, Plum-Morschel L, Rasmussen O, Rikte T, Pedersen LK, Qvist M, Sparre T. Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism. Diabetes Obes Metab. 2018 May;20(5):1140-1147. doi: 10.1111/dom.13203. Epub 2018 Jan 25.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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