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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00832182
First received: January 29, 2009
Last updated: June 8, 2012
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin aspart
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of hypoglycemic episodes and adverse events [ Time Frame: at 3 and 6 months and at the end of the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: at 3 and 6 months and at the end of the trial ] [ Designated as safety issue: No ]
  • 9-point blood glucose profile [ Time Frame: at 3 and 6 months and at the end of the trial ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: December 1999
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832182

Locations
Croatia
Zagreb, Croatia, 10 000
Czech Republic
Praha 2, Czech Republic, 12821
Israel
Tel Hashomer, Israel, 52621
Russian Federation
Moscow, Russian Federation, 125315
Slovenia
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Karin Kanc, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00832182     History of Changes
Other Study ID Numbers: ANA-1229
Study First Received: January 29, 2009
Last Updated: June 8, 2012
Health Authority: Croatia: Ministry of Health and Social Care
Israel: Ministry of Health
Russia: Federal Service for Control of Health Care and Social Development
Slovenia: Agency for Medicinal Products - Ministry of Health
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014