Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01707134
First received: October 10, 2012
Last updated: October 17, 2012
Last verified: October 2012
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Purpose
This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin aspart Drug: human soluble insulin Drug: insulin NPH |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Number of hypoglycaemic events [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of adverse events [ Designated as safety issue: No ]
- Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
- Standard safety parameters: Haematology and biochemistry [ Designated as safety issue: No ]
- HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
| Enrollment: | 753 |
| Study Start Date: | September 1997 |
| Study Completion Date: | May 2000 |
| Primary Completion Date: | May 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: insulin aspart |
Drug: insulin aspart
Injected subcutaneously (s.c, under the skin) as meal time insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
|
| Active Comparator: human insulin |
Drug: human soluble insulin
Injected subcutaneously (s.c, under the skin) as meal time insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707134
Locations
| Austria | |
| Wien, Austria, 1090 | |
| Denmark | |
| København, Denmark, 2400 | |
| Finland | |
| Kotka, Finland, 48210 | |
| Germany | |
| Giessen, Germany, 35385 | |
| Norway | |
| Haugesund, Norway, 5500 | |
| Sweden | |
| Falun, Sweden, 791 82 | |
| Switzerland | |
| Zürich, Switzerland, 8032 | |
| United Kingdom | |
| Nottingham, United Kingdom, NG7 2UH | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Hans Henrik Friberg | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01707134 History of Changes |
| Other Study ID Numbers: | ANA/DCD/050 |
| Study First Received: | October 10, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Norway: Norwegian Medicines Agency Sweden: Medical Products Agency Switzerland: Federal Office of Public Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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 May 22, 2013