NCT01520818|CompletedPhase 3

Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-1075

Study Type

interventional

Target

666

Locations

5 countries

Sites

Timeline

RegisteredJan 2012

StartedMar 2000

CompletionApr 2001

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

666

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Mar 2000

Geographic Reach

5 countries

77 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

1.1 years study duration

Study Start

First participant enrolled

March 1, 2000

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed

10.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed

Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 25, 2012

Last Update Submit

January 3, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes (5)

Blood glucose profiles
Adverse events
Hypoglycaemic episodes
Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)

Study Arms (2)

BIAsp 50 or 70

EXPERIMENTAL

Drug: biphasic insulin aspart 50Drug: biphasic insulin aspart 70

BHI 30

ACTIVE COMPARATOR

Drug: biphasic human insulin 30

Interventions

biphasic insulin aspart 50DRUG

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m\^2 will receive BIAsp 50

BIAsp 50 or 70

biphasic insulin aspart 70DRUG

Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70

BIAsp 50 or 70

biphasic human insulin 30DRUG

Administered subcutaneously (s.c., under the skin), twice a day

BHI 30

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 1 or Type 2 diabetes
Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
Body mass index (BMI) maximum 40.0 kg/m\^2

You may not qualify if:

History of drug or alcohol dependence
Impaired hepatic function
Impaired renal function
Cardiac disease
Proliferative retinopathy
Total daily insulin dose at least 1.80 IU/kg

Contact the study team to confirm eligibility.