Comparison of Two Identical NN1250 Formulations in Healthy Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: insulin degludec

Study type

Interventional

Funder types

Industry

Identifiers

NCT01193387

U1111-1115-5279 (Other Identifier)

NN1250-3769

2010-018908-83 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug exposure to the body.

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
Body mass index 18.0-27.0 kg/m^2 (both inclusive)

Exclusion criteria

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)