NCT00832182|CompletedPhase 3

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

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

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

ANA-1229

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredJan 2009

StartedDec 1999

CompletionNov 2002

Brief Summary

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

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Dec 1999

Longer than P75 for phase_3 diabetes

Geographic Reach

5 countries

10 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

2.9 years study duration

Study Start

First participant enrolled

December 22, 1999

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2002

Completed

6.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed

Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

January 29, 2009

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Number of hypoglycemic episodes and adverse events
at 3 and 6 months and at the end of the trial

Secondary Outcomes (2)

HbA1c
at 3 and 6 months and at the end of the trial
9-point blood glucose profile
at 3 and 6 months and at the end of the trial

Study Arms (1)

Insulin aspart and neutral protamine Hagedorn insulin

EXPERIMENTAL

Drug: insulin aspartDrug: insulin NPH

Interventions

insulin aspartDRUG

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

Insulin aspart and neutral protamine Hagedorn insulin

insulin NPHDRUG

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

Insulin aspart and neutral protamine Hagedorn insulin

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.