A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

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

NCT01114542

2009-015897-36 (EudraCT Number)

NN1250-1993

U1111-1113-6772 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 66 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
• Current total daily insulin treatment lower than 1.2 (I)U/kg/day
• Body mass index 18.0-28.0 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
• 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
• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 6 patient groups

IDeg 0.4 U/kg

Experimental group

Treatment:

Drug: insulin degludec

IDeg 0.6 U/kg

Experimental group

Treatment:

Drug: insulin degludec

IDeg 0.8 U/kg

Experimental group

Treatment:

Drug: insulin degludec

IGlar 0.4 U/kg

Active Comparator group

Treatment:

Drug: insulin glargine

IGlar 0.6 U/kg

Active Comparator group

Treatment:

Drug: insulin glargine

IGlar 0.8 U/kg

Active Comparator group

Treatment:

Drug: insulin glargine