A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467414

NN1250-3763

2011-001850-27 (EudraCT Number)

U1111-1120-7444 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.

Enrollment: 1 patient

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female Japanese subject aged 20-70 years (both inclusive)
• Japanese passport holder
• Japanese-born parents
• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Treated with insulin for at least 3 months
• Body Mass Index (BMI) maximum 33.0 kg/m^2
• Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
• Fasting C-peptide below 1.0 nmol/L

Exclusion criteria

• Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
• 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period
• Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

NN1250

Experimental group

Treatment:

Drug: insulin degludec