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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin aspart; Drug: insulin NPH

• Registration Number: NCT00832182
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12-22
• Primary Completion: 2002-11-25
• Study Completion: 2002-11-25
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study First Posted: 2009-01-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin aspart and neutral protamine Hagedorn insulin	insulin NPH	-
Insulin aspart and neutral protamine Hagedorn insulin	insulin aspart	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇮 Ljubljana, Slovenia