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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00978627
First received: September 16, 2009
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

Main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec/insulin aspart
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: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: 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:


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

Primary Outcome Measures:
  • Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]
  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ] [ Designated as safety issue: No ]
  • Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) after 52 weeks of treatment [ Time Frame: Week 0, Week 52 ] [ Designated as safety issue: No ]

Enrollment: 548
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp OD Drug: insulin degludec/insulin aspart
Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.
Active Comparator: IDet Drug: insulin detemir
Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) as meal time insulin. Dose was individually adjusted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FOR THE MAIN TRIAL, NN5401-3594:
  • Type 1 diabetes mellitus for at least 12 months
  • Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
  • HbA1c 7.0-10.0% (both inclusive)
  • BMI (Body Mass Index) below or equal to 35.0 kg/m^2
  • FOR THE EXTENSION TRIAL, NN5401-3645:
  • The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

  • FOR THE MAIN TRIAL, NN5401-3594:
  • Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer
  • FOR THE EXTENSION TRIAL, NN5401-3645:
  • 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: NCT00978627

  Show 37 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452), pgad, kit maria truelsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00978627     History of Changes
Obsolete Identifiers: NCT01087606
Other Study ID Numbers: NN5401-3594, 2008-005769-71, U1111-1111-8943, 2009-013412-13, U1111-1113-2475
Study First Received: September 16, 2009
Last Updated: November 28, 2013
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: Ministry of Health
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 April 16, 2014