A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154881

2009-017281-23 (EudraCT Number)

U1111-1114-9099 (Other Identifier)

NN1250-1987

Details and patient eligibility

About

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index (BMI) below or equal to 35.0 kg/m2

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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49 participants in 4 patient groups

IDeg 100U/mL 0.4U/kg

Experimental group

Treatment:

Drug: insulin degludec

IDeg 100U/mL 0.6U/kg

Experimental group

Treatment:

Drug: insulin degludec

IDeg 100U/mL 0.8U/kg

Experimental group

Treatment:

Drug: insulin degludec

IDeg 200U/mL 0.6U/kg

Experimental group

Treatment:

Drug: insulin degludec