Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes

February 22, 2017 updated by: Novo Nordisk A/S

An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

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

  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk INvestigational Site
  • Czech Republic
      • Praha 10, Czech Republic, 10034
        • Novo Nordisk INvestigational Site
      • Praha 2, Czech Republic, 12821
        • Novo Nordisk INvestigational Site
  • Israel
      • Tel Hashomer, Israel, 52621
        • Novo Nordisk INvestigational Site
  • Russian Federation
      • Moscow, Russian Federation, 119435
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 125315
        • Novo Nordisk INvestigational Site
      • Moscow, Russian Federation, 129110
        • Novo Nordisk INvestigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • Novo Nordisk INvestigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • The subject must have completed the ANA/DCD/065 trial

Exclusion Criteria:

  • Impaired hepatic function
  • Impaired renal function
  • Total daily insulin requirements of more than 1.4 U/kg
  • Cardiac problems
  • Uncontrolled hypertension
  • Known or suspected allergy to trial product or related products
  • Current hypoglycaemic unawareness as judged by the investigator
  • Known or suspect abuse of alcohol or narcotics
  • Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
  • Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin aspart and neutral protamine Hagedorn insulin
Drug: insulin aspart
Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
Drug: insulin NPH
Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hypoglycemic episodes and adverse events
Time Frame: at 3 and 6 months and at the end of the trial
at 3 and 6 months and at the end of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at 3 and 6 months and at the end of the trial
at 3 and 6 months and at the end of the trial
9-point blood glucose profile
Time Frame: at 3 and 6 months and at the end of the trial
at 3 and 6 months and at the end of the trial

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

  • Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229

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 (Actual)

December 22, 1999

Primary Completion (Actual)

November 25, 2002

Study Completion (Actual)

November 25, 2002

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-1229

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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