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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin aspart
* Drug: insulin NPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin aspart and neutral protamine Hagedorn insulin<br> | Drug: insulin aspart<br>* 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<br>Drug: insulin NPH<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |