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
About this trial
This is an interventional other trial for Diabetes
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)
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
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
Learn more about this trial
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
We'll reach out to this number within 24 hrs