Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 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

PHASE4

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-22

Study Completion Date

2003-04-24

Brief Summary

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This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

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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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BIAsp

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

Insulin aspart

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

insulin aspart

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) before lunch

Interventions

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biphasic insulin aspart 30

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

Intervention Type DRUG

insulin aspart

Administrated subcutaneously (s.c., under the skin) before lunch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
* HbA1c (glycosylated haemoglobin) equal to or below 12%
* Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria

* History of drug or alcohol dependence
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Previous participation in this trial
* Receipt of any investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No