Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

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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Mix30

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

SIAC

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

Interventions

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insulin degludec/insulin aspart

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

Intervention Type DRUG

biphasic insulin aspart 30

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus
* Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
* HbA1c below 10.0%
* Body Mass Index (BMI) \< 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
* Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: TZD\]) within the last 12 weeks prior to screening

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No