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

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ClinicalTrials.gov Identifier: NCT00832182
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin aspart Drug: insulin NPH Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 22, 1999
Actual Primary Completion Date : November 25, 2002
Actual Study Completion Date : November 25, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Insulin aspart and neutral protamine Hagedorn insulin 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
Drug: 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



Primary Outcome Measures :
  1. Number of hypoglycemic episodes and adverse events [ Time Frame: at 3 and 6 months and at the end of the trial ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: at 3 and 6 months and at the end of the trial ]
  2. 9-point blood glucose profile [ Time Frame: at 3 and 6 months and at the end of the trial ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832182


Locations
Croatia
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Czech Republic
Novo Nordisk Investigational Site
Praha 10, Czech Republic, 10034
Novo Nordisk Investigational Site
Praha 2, Czech Republic, 12821
Israel
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125315
Novo Nordisk Investigational Site
Moscow, Russian Federation, 129110
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194354
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00832182     History of Changes
Other Study ID Numbers: ANA-1229
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants