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

• Status: Completed
• Trial end date: 2016-02-25
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

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)