Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-05-31

Brief Summary

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This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIBA

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime

insulin aspart

Intervention Type DRUG

Injection subcutaneously immediately before each meal.

Insulin Detemir

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Injection subcutaneously at bedtime

insulin aspart

Intervention Type DRUG

Injection subcutaneously immediately before each meal.

Interventions

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insulin degludec

The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime

Intervention Type DRUG

insulin detemir

Injection subcutaneously at bedtime

Intervention Type DRUG

insulin aspart

Injection subcutaneously immediately before each meal.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 1 diabetes mellitus more than one year
* Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
* HbA1c below 10.0%
* Body Mass Index (BMI) below 30.0 kg/m\^2

Exclusion Criteria

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment with total insulin dose of more than 100 U or IU/day
* Current treatment or expected to start treatment with systemic corticosteroid

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No