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Clinical Trials/NCT01520818
NCT01520818
Completed
Phase 3

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/S1 site in 1 country666 target enrollmentStarted: March 2000Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Interventionsbiphasic insulin aspart 50biphasic insulin aspart 70biphasic human insulin 30
Drugsbiphasic insulin aspart 50biphasic insulin aspart 70biphasic human insulin 30

Overview

Phase
Phase 3
Status
Completed
Enrollment
666
Locations
1
Primary Endpoint
HbA1c (glycosylated haemoglobin A1c)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

BIAsp 50 or 70

Experimental

Intervention: biphasic insulin aspart 50 (Drug)

BIAsp 50 or 70

Experimental

Intervention: biphasic insulin aspart 70 (Drug)

BHI 30

Active Comparator

Intervention: biphasic human insulin 30 (Drug)

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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