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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin degludec

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01135927

JapicCTI-101158 (Other Identifier)

U1111-1113-6722 (Other Identifier)

NN1250-1996

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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)