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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832182
• Other study ID #: ANA-1229
• Status: Completed
• Phase: Phase 3
• First received: January 29, 2009
• Last updated: February 22, 2017
• Start date: December 22, 1999
• Est. completion date: November 25, 2002

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 25, 2002
• Est. primary completion date: November 25, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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
• 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

Locations

Country	Name	City	State
Croatia	Novo Nordisk Investigational Site	Zagreb
Czech Republic	Novo Nordisk Investigational Site	Praha 10
Czech Republic	Novo Nordisk Investigational Site	Praha 2
Israel	Novo Nordisk Investigational Site	Tel Hashomer
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Slovenia	Novo Nordisk Investigational Site	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Croatia,  Czech Republic,  Israel,  Russian Federation,  Slovenia, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic episodes and adverse events		at 3 and 6 months and at the end of the trial
Secondary	HbA1c		at 3 and 6 months and at the end of the trial
Secondary	9-point blood glucose profile		at 3 and 6 months and at the end of the trial

External Links

•   Clinical Trials at Novo Nordisk