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Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BOOST™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01087606
First received: March 15, 2010
Last updated: February 23, 2011
Last verified: December 2010
History of Changes
  Purpose

This trial is conducted in Europe, Oceania and in the United States of America (USA).

The aim of this clinical trial is to compare the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart in type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: NN5401
Drug: insulin detemir
Drug: insulin aspart
 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 Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Adverse events and number of hypoglycaemic episodes [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]
  • Fasting plasma glucose (FPG) [ Time Frame: after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 + 26 weeks of treatment in extension) ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN5401
NN5401 injected subcutaneously (under the skin) with a meal. The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart is injected subcutaneously (under the skin) with the remaining meals. The dose will be individually adjusted.
Active Comparator: B Drug: insulin detemir
Insulin detemir injected subcutaneously (under the skin) once daily. The dose will be individually adjusted.
Drug: insulin aspart
Insulin aspart is injected subcutaneously (under the skin) with the meals. The dose will be individually adjusted

  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 treatment period in trial NN5401-3594

Exclusion Criteria:

  • Anticipated significant lifestyle changes during the trial
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087606

  Show 34 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Kit Maria Truelsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01087606     History of Changes
Other Study ID Numbers: NN5401-3645, 2009-013412-13, U1111-1113-2475
Study First Received: March 15, 2010
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Poland: Ministry of Health
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of 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, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013