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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: insulin degludec
Drug: insulin glargine

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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