Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076634

NN1250-3678

2009-014555-68 (EudraCT Number)

U1111-1112-7714 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 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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33 participants in 2 patient groups

IDeg 100 U/mL

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

IDeg 200 U/mL

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec