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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:
ClinicalTrials.gov Identifier:
NCT00832182
First Posted: January 30, 2009
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
January 29, 2009
January 30, 2009
February 23, 2017
December 22, 1999
November 25, 2002   (Final data collection date for primary outcome measure)
Number of hypoglycemic episodes and adverse events [ Time Frame: at 3 and 6 months and at the end of the trial ]
Same as current
Complete list of historical versions of study NCT00832182 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: at 3 and 6 months and at the end of the trial ]
  • 9-point blood glucose profile [ Time Frame: at 3 and 6 months and at the end of the trial ]
Same as current
Not Provided
Not Provided
 
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
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
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
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • 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
Experimental: Insulin aspart and neutral protamine Hagedorn insulin
Interventions:
  • Drug: insulin aspart
  • Drug: insulin NPH
Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
November 25, 2002
November 25, 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Czech Republic,   Israel,   Russian Federation,   Slovenia
 
 
NCT00832182
ANA-1229
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP