NCT02627287

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2016

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

November 27, 2015

Last Update Submit

February 6, 2018

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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 Outcomes (8)

  • Subjects' confidence in injection completion (delivery of correct, full dose)

    Injection completed within 2 minutes after needle insertion

  • Amount of liquid on the skin (placebo solution or tissue fluid)

    Injection completed within 2 minutes after needle insertion

  • Subjects' reaction time

    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

  • +3 more secondary outcomes

Study Arms (2)

DV3316 pen-injector

EXPERIMENTAL
Device: DV3316 pen-injectorDrug: placebo

FlexPen®

ACTIVE COMPARATOR
Device: FlexPen®Drug: placebo

Interventions

FlexPen®DEVICE

For subcutaneously (s.c. under the skin) injection.

FlexPen®
DV3316 pen-injectorDEVICE

For subcutaneously (s.c. under the skin) injection.

DV3316 pen-injector
placeboDRUG

For subcutaneously (s.c. under the skin) injection

DV3316 pen-injectorFlexPen®

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (2)

  • 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.

    PMID: 29369494RESULT

  • 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.

    PMID: 29369493RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2015

First Posted

December 10, 2015

Study Start

December 1, 2015

Primary Completion

February 25, 2016

Study Completion

February 25, 2016

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

DE(2)