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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486940
First received: December 5, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Rikke Nedergaard Bischoff Novo Nordisk A/S
  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, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Isophane
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014