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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:
ClinicalTrials.gov Identifier:
NCT00978627
First Posted: September 17, 2009
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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.

The 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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Change from baseline in HbA1c after 26 weeks of treatment

  • Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 53 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.

  • Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 53 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.

  • Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 53 + 7 days of follow up ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.


Secondary Outcome Measures:
  • Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

  • Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 [ Time Frame: Week 26 ]
    Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

  • Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 53 ]
    Change from baseline in HbA1c after 52 weeks of treatment

  • Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]
    Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.

  • Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Week 0, Week 53 ]
    Change from baseline in FPG after 52 weeks of treatment.


Enrollment: 548
Study Start Date: August 2009
Study Completion Date: May 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978627


  Hide Study Locations
Locations
United States, California
Novo Nordisk Investigational Site
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site
Lancaster, California, United States, 93534
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
North Hollywood, California, United States, 91606
Novo Nordisk Investigational Site
Salinas, California, United States, 93901
Novo Nordisk Investigational Site
Valencia, California, United States, 91355
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
United States, Florida
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
Novo Nordisk Investigational Site
Miami, Florida, United States, 33169
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
Novo Nordisk Investigational Site
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
United States, Kansas
Novo Nordisk Investigational Site
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
United States, Minnesota
Novo Nordisk Investigational Site
Eagan, Minnesota, United States, 55123
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Missouri
Novo Nordisk Investigational Site
St. Peters, Missouri, United States, 63376
United States, Montana
Novo Nordisk Investigational Site
Butte, Montana, United States, 59701
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Novo Nordisk Investigational Site
Henderson, Nevada, United States, 89052-2649
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
Northport, New York, United States, 11768
United States, North Carolina
Novo Nordisk Investigational Site
Morehead City, North Carolina, United States, 28557
United States, South Carolina
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78240
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
Australia, New South Wales
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
Australia, South Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia, 5035
Australia, Victoria
Novo Nordisk Investigational Site
Box Hill, Victoria, Australia, 3128
Australia
Novo Nordisk Investigational Site
Fitzroy, Australia, 3065
Novo Nordisk Investigational Site
Geelong, Australia, 3220
Denmark
Novo Nordisk Investigational Site
Aalborg, Denmark, 9100
Novo Nordisk Investigational Site
Gentofte, Denmark, 2820
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
France
Novo Nordisk Investigational Site
Auxerre, France, 89000
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
Nimes, France, 30006
Novo Nordisk Investigational Site
Pointe à Pitre, France, 97159
Israel
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Novo Nordisk Investigational Site
Rishon Le Zion, Israel, 75650
Novo Nordisk Investigational Site
Tel Hashomer, Israel, 52621
Poland
Novo Nordisk Investigational Site
Lodz, Poland, 91-738
Novo Nordisk Investigational Site
Lodz, Poland, 93-338
Novo Nordisk Investigational Site
Sopot, Poland, 81-756
Novo Nordisk Investigational Site
Szczecin, Poland, 70-376
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
Novo Nordisk Investigational Site
Warszawa, Poland, 02-692
Puerto Rico
Novo Nordisk Investigational Site
Bayamon, Puerto Rico, 00961
Romania
Novo Nordisk Investigational Site
Cluj Napoca, Cluj, Romania, 400006
Novo Nordisk Investigational Site
Brasov, Romania, 500365
Novo Nordisk Investigational Site
Bucharest, Romania, 020042
Novo Nordisk Investigational Site
Bucharest, Romania, 020475
Novo Nordisk Investigational Site
Buzau, Romania, 120203
Novo Nordisk Investigational Site
Iasi, Romania, 700547
Novo Nordisk Investigational Site
Oradea, Romania, 410169
Novo Nordisk Investigational Site
Sibiu, Romania, 550245
Russian Federation
Novo Nordisk Investigational Site
Kemerovo, Russian Federation, 650066
Novo Nordisk Investigational Site
Kursk, Russian Federation, 305035
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125367
Novo Nordisk Investigational Site
Penza, Russian Federation, 440026
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 195257
Novo Nordisk Investigational Site
Samara, Russian Federation, 443067
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410053
Novo Nordisk Investigational Site
Saratov, Russian Federation, 410710
Novo Nordisk Investigational Site
Smolensk, Russian Federation, 214019
Novo Nordisk Investigational Site
Volgograd, Russian Federation, 400138
United Kingdom
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Edinburgh, United Kingdom, EH16 4SA
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE1 5WW
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L7 8XP
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LE
Novo Nordisk Investigational Site
Salford, United Kingdom, M6 8HD
Novo Nordisk Investigational Site
Wirral, Merseyside, United Kingdom, CH63 4JY
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: NCT00978627     History of Changes
Obsolete Identifiers: NCT01087606
Other Study ID Numbers: NN5401-3594
2008-005769-71 ( EudraCT Number )
U1111-1111-8943 ( Other Identifier: WHO )
2009-013412-13 ( EudraCT Number )
U1111-1113-2475 ( Other Identifier: WHO )
First Submitted: September 16, 2009
First Posted: September 17, 2009
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: March 20, 2017
Last Verified: February 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
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs