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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486940
First received: December 5, 2011
Last updated: January 26, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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)

Secondary Outcome Measures:
  • Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
  • 8-point blood glucose profiles
  • Incidence of self-recorded hypoglycaemic episodes
  • Incidence of adverse events

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 75 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: January 26, 2017

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
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017