A Trial Investigating the Within-subject Variability of NN1250 in Subjects 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

NCT00961324

2008-008308-42 (EudraCT Number)

NN1250-1991

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18-65 years (both inclusive)
• 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: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

IDeg

Experimental group

Treatment:

Drug: insulin degludec

IGlar

Experimental group

Treatment:

Drug: insulin glargine