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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Diabetes Mellitus, Type 2

Treatments

Device: FlexPen®

Drug: placebo

Device: DV3316 pen-injector

Study type

Interventional

Funder types

Industry

Identifiers

U1111-1163-5039 (Other Identifier)

INS-4208

2014-004802-13 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.

Enrollment

150 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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)