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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin

Criteria

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