A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135927
• Other study ID #: NN1250-1996
• Secondary ID: U1111-1113-6722J
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2010
• Last updated: January 19, 2017
• Start date: June 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

• Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)

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

• Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 (only clamp period)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days
• insulin detemir
Insulin detemir injected s.c. (under the skin) once daily for 6 days

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Haahr H, Ikushima I, Hirao K, Kiyomi F, Heise T. Similar pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese and Caucasian subjects with T1DM. J Diab Invest 2012; 3 (Suppl. 1): 197 (Abstract PCS-16-6)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the NN1250 GIR (glucose infusion rate) curve		During one dosing interval at steady state
Secondary	Area under the serum insulin detemir concentration-time curve		During one dosing interval at steady state

External Links

•   Clinical Trials at Novo Nordisk