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A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®)

This study is currently recruiting participants.
Verified March 2013 by Novo Nordisk
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01814137
First received: March 15, 2013
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

This trial is conducted globally. The aim of the trial is to compare efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an extension to trial NN5401-3941 (NCT01680341).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: IDegAsp
Drug: IDeg
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: A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily (BOOST®: INTENSIFY BID)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 97
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp BID + IAsp OD Drug: IDegAsp
For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Drug: insulin aspart

For subcutaneous (s.c., under the skin) administration once daily.

Dose of IDegAsp and IAsp are individually adjusted.
Experimental: IDeg OD + IAsp TID Drug: IDeg
For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
Drug: insulin aspart

For subcutaneous (s.c., under the skin) administration three times a day.

Dose of IDeg and IAsp are individually adjusted.

  Eligibility

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

Inclusion Criteria:

  • HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941 (NCT01680341), by central laboratory

Exclusion Criteria:

  • Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
  • Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal
  • Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to or above 1.3 mg/dL) for females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814137

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 29 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anette Skov Pedersen Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01814137     History of Changes
Other Study ID Numbers: NN5401-4003, 2012-003152-37, U1111-1132-2674
Study First Received: March 15, 2013
Last Updated: March 22, 2013
Health Authority: Algeria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: Ministry of Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013