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

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

An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

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

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Wien, Austria, A 1080
        • Novo Nordisk Investigational Site
  • Germany
      • Anklam, Germany, 17389
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10559
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 14089
        • Novo Nordisk Investigational Site
      • Cottbus, Germany, 03048
        • Novo Nordisk Investigational Site
      • Erkner, Germany, 15537
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20251
        • Novo Nordisk Investigational Site
      • Jena, Germany, 07743
        • Novo Nordisk Investigational Site
      • Leipzig, Germany, 04177
        • Novo Nordisk Investigational Site
      • München, Germany, 80804
        • Novo Nordisk Investigational Site
      • Neunkirchen, Germany, 66538
        • Novo Nordisk Investigational Site
      • Quakenbrück, Germany, 49610
        • Novo Nordisk Investigational Site
      • Rostock, Germany, 18057
        • Novo Nordisk Investigational Site
      • Saarlouis, Germany, 66740
        • Novo Nordisk Investigational Site
      • Schwedt, Germany, 16303
        • Novo Nordisk Investigational Site
      • Ulm, Germany, 89081
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97080
        • Novo Nordisk Investigational Site
  • Ireland
      • Cork, Ireland
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 8
        • Novo Nordisk Investigational Site
      • Dublin 9, Ireland
        • Novo Nordisk Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5SS
        • Novo Nordisk Investigational Site
      • Blackburn, United Kingdom, BB3 3LR
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS2 8HW
        • Novo Nordisk Investigational Site
      • Kettering, United Kingdom, NN16 8UZ
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Novo Nordisk Investigational Site
      • Livingstone, United Kingdom, EH54 6PP
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Paisley, United Kingdom, PA2 9PL
        • 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:

  • Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
  • Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
  • Body mass index (BMI) below or equal to 35.0 kg/m^2
  • HbA1c below or equal to 11.0%

Exclusion Criteria:

  • Total daily insulin dose at least 1.4 IU/kg
  • Treatment with oral hypoglycaemic agents within the month prior to inclusion
  • Recurrent severe hypoglycaemia (as judged by the investigator)
  • Active proliferative retinopathy
  • Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
  • History of pancreatitis

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: biphasic human insulin
Injected subcutaneously (under the skin) twice daily
Experimental: A
Drug: biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

Outcome Measure
Occurrence of adverse events
Incidence of hypoglycaemic episodes
8-point blood glucose profiles

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

April 1, 1998

Primary Completion (Actual)

September 1, 1998

Study Completion (Actual)

September 1, 1998

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

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

  • ANA/DCD/038

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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