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

January 3, 2017 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

666

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1090
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1020
        • Novo Nordisk Investigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk Investigational Site
      • Genk, Belgium, 3600
        • Novo Nordisk Investigational Site
      • Jumet, Belgium, 6040
        • Novo Nordisk Investigational Site
      • Liège, Belgium, 4000
        • Novo Nordisk Investigational Site
  • France
      • Amiens, France
        • Novo Nordisk Investigational Site
      • Avignon, France, 84902
        • Novo Nordisk Investigational Site
      • Bagnols-sur-ceze, France, 30200
        • Novo Nordisk Investigational Site
      • Bordeaux, France, 33076
        • Novo Nordisk Investigational Site
      • Caen, France, 14033
        • Novo Nordisk Investigational Site
      • Colmar, France, 68024
        • Novo Nordisk Investigational Site
      • DIJON cedex, France, 21079
        • Novo Nordisk Investigational Site
      • Dommartin Les Toul, France, 54201
        • Novo Nordisk Investigational Site
      • GRENOBLE cedex, France, 38043
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • Lorient, France, 56322
        • Novo Nordisk Investigational Site
      • Lyon, France, 69437
        • Novo Nordisk Investigational Site
      • Macon, France, 71000
        • Novo Nordisk Investigational Site
      • Marseille, France, 13009
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Nimes, France, 30006
        • Novo Nordisk Investigational Site
      • Orleans, France
        • Novo Nordisk Investigational Site
      • Paris, France, 75014
        • Novo Nordisk Investigational Site
      • Paris, France, 75007
        • Novo Nordisk Investigational Site
      • Reims, France, 51056
        • Novo Nordisk Investigational Site
      • Roubaix, France, 59056
        • Novo Nordisk Investigational Site
      • Saint Etienne, France
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67091
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31054
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Dublin, Ireland
        • Novo Nordisk Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Novo Nordisk Investigational Site
      • Amersfoort, Netherlands, 3816 CP
        • Novo Nordisk Investigational Site
      • Arnhem, Netherlands
        • Novo Nordisk Investigational Site
      • Beverwijk, Netherlands
        • Novo Nordisk Investigational Site
      • Delft, Netherlands, 2625 AD
        • Novo Nordisk Investigational Site
      • Den Bosch, Netherlands, 5223 GV
        • Novo Nordisk Investigational Site
      • Den Haag, Netherlands, 2597 AX
        • Novo Nordisk Investigational Site
      • Einhoven, Netherlands
        • Novo Nordisk Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3021 HC
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3011 TD
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Ayrsh, United Kingdom, KA2 0BE
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Brighton, United Kingdom, BN2 5BE
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV1 4FH
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Novo Nordisk Investigational Site
      • Edgware, United Kingdom, HA8 0AD
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Novo Nordisk Investigational Site
      • Exeter, United Kingdom, EX2 5AX
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G51 4TF
        • Novo Nordisk Investigational Site
      • Haywards Heath, United Kingdom, RH16 4EX
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Leeds, United Kingdom, LS9 7TF
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Novo Nordisk Investigational Site
      • London, United Kingdom, N19 3UA
        • Novo Nordisk Investigational Site
      • London, United Kingdom, E11 1NR
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M8 5RB
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 0JE
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Paisley, United Kingdom, PA2 9PL
        • Novo Nordisk Investigational Site
      • Poole, United Kingdom, BH15 2JB
        • Novo Nordisk Investigational Site
      • Rugby, United Kingdom, CV22 5PX
        • Novo Nordisk Investigational Site
      • Scunthorpe, United Kingdom, DN15 7BH
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO14 OYG
        • Novo Nordisk Investigational Site
      • Sunderland, United Kingdom, SR4 7TP
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD18 0HB
        • Novo Nordisk Investigational Site
      • Whiston, United Kingdom, L35 5DR
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BIAsp 50 or 70
Drug: biphasic insulin aspart 50
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
Drug: biphasic insulin aspart 70
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
ACTIVE_COMPARATOR: BHI 30
Drug: biphasic human insulin 30
Administered subcutaneously (s.c., under the skin), twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

Outcome Measure
Adverse events
Hypoglycaemic episodes
Blood glucose profiles
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2000

Primary Completion (ACTUAL)

April 1, 2001

Study Completion (ACTUAL)

April 1, 2001

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (ESTIMATE)

January 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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