Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 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

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-08

Study Completion Date

2003-11-26

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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biphasic insulin aspart

Intervention Type DRUG

biphasic human insulin

Intervention Type DRUG

Other Intervention Names

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BIASP

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetes for at least 3 months
* Stabilised on current treatment with premixed human insulin for at least 4 weeks
* Body mass index (BMI) between 18-40 kg/m2
* HbA1c below 13.0%
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria

* The receipt of any investigational drug within the last three months prior to this trial
* Has a history of drug abuse or alcohol dependence within the last 5 years
* Active proliferative retinopathy requiring laser or surgical intervention within the last year
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related product

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No