NCT00617565|CompletedPhase 3

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-1536

Study Type

interventional

Target

219

Locations

1 country

Sites

Timeline

RegisteredFeb 2008

StartedJul 2003

CompletionNov 2003

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

219

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jul 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

July 8, 2003

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2003

Completed

4.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed

12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

February 6, 2008

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

2-hr postprandial plasma glucose (PPPG) excursion
after 12 weeks of treatment

Secondary Outcomes (2)

HbA1c
Fasting plasma glucose

Interventions

biphasic insulin aspartDRUG

Also known as: BIASP

biphasic human insulinDRUG

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.