Comparison of Two 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

NCT00966368

P/44/2010 (Other Identifier)

U1111-1122-2992 (Other Identifier)

P/96/2011 (Other Identifier)

NN1250-1988

2011-002949-35 (EudraCT Number)

Details and patient eligibility

About

This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.

Enrollment: 27 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 ECG (electrocardiogram), 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 2 patient groups

IDeg E

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

IDeg M

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec