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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467414

Enrollment

Registered

2011-11-08

Start date

2011-10-31

Completion date

2011-12-31

Last updated

2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin degludec

Injected s.c. (under the skin) once daily for 6 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026