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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days

B

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Insulin detemir injected s.c. (under the skin) once daily for 6 days

Interventions

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insulin degludec

NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days

Intervention Type DRUG

insulin detemir

Insulin detemir injected s.c. (under the skin) once daily for 6 days

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No