A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin glargine; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030926

NN1250-1995

U1111-1112-4715 (Other Identifier)

2008-008306-43 (EudraCT Number)

Details and patient eligibility

About

This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.

Enrollment: 39 patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 6-65 years (both inclusive)
• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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
• Not able or willing to refrain from smoking 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 4 patient groups

A1, first period

Experimental group

Treatment:

Drug: insulin degludec

A2, second period

Active Comparator group

Treatment:

Drug: insulin glargine

B1, first period

Active Comparator group

Treatment:

Drug: insulin glargine

B2, second period

Experimental group

Treatment:

Drug: insulin degludec