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Completed

NCT Number: NCT02627287

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®.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Mainz, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FlexPen®

Device

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

DV3316 pen-injector

Device

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

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2015
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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