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:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00832182
First received: January 29, 2009
Last updated: June 8, 2012
Last verified: September 2011
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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:
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
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
Investigators
| Study Director: | Karin Kanc, MD, PhD | Novo Nordisk |
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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin aspart Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013