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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627287
• Other study ID #: INS-4208
• Secondary ID: 2014-004802-13U1
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2015
• Last updated: February 6, 2018
• Start date: December 1, 2015
• Est. completion date: February 25, 2016

Study information

• Verified date: February 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 25, 2016
• Est. primary completion date: February 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• FlexPen®
For subcutaneously (s.c. under the skin) injection.
• DV3316 pen-injector
For subcutaneously (s.c. under the skin) injection.

Drug:
• placebo
For subcutaneously (s.c. under the skin) injection

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & 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 Jan 25. doi: 10.1111/dom — View Citation

Zijlstra E, Coester HV, Heise T, Plum-Mörschel 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. 2017 Dec 27. doi: 10.1111/dom — View Citation

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk