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

Phase 1

Terminated

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin degludec

• Registration Number: NCT01467414
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NN1250	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve during one dosing interval at steady state	Within 0-24 hours after last dosing

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin degludec concentration-time curve during one dosing interval at steady state	Within 0-24 hours after last dosing
Maximum glucose infusion rate at steady state	Within 0-24 hours after last dosing
Maximum observed serum insulin degludec concentration at steady state	Within 0-24 hours after last dosing