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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2016-02-25

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DV3316 pen-injector

Group Type EXPERIMENTAL

DV3316 pen-injector

Intervention Type DEVICE

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

placebo

Intervention Type DRUG

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

FlexPen®

Group Type ACTIVE_COMPARATOR

FlexPen®

Intervention Type DEVICE

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

placebo

Intervention Type DRUG

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

Interventions

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FlexPen®

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

Intervention Type DEVICE

DV3316 pen-injector

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

Intervention Type DEVICE

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No