Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01486940
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
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Purpose
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin detemir Drug: insulin aspart Drug: insulin NPH Drug: human soluble insulin |
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: | A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin, NPH
Insulin human
Insulin, isophane
Insulin aspart
Insulin detemir
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Intra-subject variation in home measured blood glucose (3-point blood glucose profiles) [ Designated as safety issue: No ]
- 8-point blood glucose profiles [ Designated as safety issue: No ]
- Incidence of self-recorded hypoglycaemic episodes [ Designated as safety issue: No ]
- Incidence of adverse events [ Designated as safety issue: No ]
| Enrollment: | 598 |
| Study Start Date: | March 2002 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Basal/bolus regimen 1 |
Drug: insulin detemir
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Drug: insulin aspart
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
|
| Active Comparator: Basal/bolus regimen 2 |
Drug: insulin NPH
Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
Drug: human soluble insulin
Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 diabetes for at least 12 months
- Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- BMI below or equal to 35 kg/m^2
- HbA1c below or equal to 12%
Exclusion Criteria:
- Proliferative retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- Subjects with known hypoglycaemic unawareness as judged by the Investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486940
Locations
| Argentina | |
| Moron, Argentina | |
| Croatia | |
| Varazdin, Croatia, 42 000 | |
| Czech Republic | |
| Plzen - Lochotin, Czech Republic, 30460 | |
| Denmark | |
| Slagelse, Denmark, 4200 | |
| Finland | |
| Pärnu, Finland, 80010 | |
| France | |
| Poitiers, France | |
| Greece | |
| Athens, Greece, GR-11527 | |
| Italy | |
| Asti, Italy, 14100 | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Norway | |
| Arendal, Norway, 4841 | |
| Poland | |
| Krakow, Poland, 31-501 | |
| Romania | |
| Timisoara, Romania, 300736 | |
| Russian Federation | |
| Moscow, Russian Federation, 117036 | |
| Slovakia | |
| Moldava nad Bodvou, Slovakia, 045 01 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Rikke Nedergaard Bischoff | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01486940 History of Changes |
| Other Study ID Numbers: | NN304-1374 |
| Study First Received: | December 5, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency Fimea France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Greece: Ministry of Health & Social Solidarity - National Organizaion for Medicines (EOF) Italy: AIFA, National Medicines Agency Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia Norway: Norwegian Medicines Control Authority Poland: Ministry of Health and Social Security Russia: Ministry of Health of the Russian Federation Slovakia: 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 Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013