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

Diabetes Mellitus, Type 2 Clinical Trial

— BOOST®  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814137
• Other study ID #: NN5401-4003
• Secondary ID: 2012-003152-37U1
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2013
• Last updated: November 13, 2015
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Algeria: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesMalaysia: Ministry of HealthTurkey: Ministry of Health Drug and Pharmaceutical DepartmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart
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).
• insulin degludec
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).
• insulin aspart
For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
• insulin aspart
For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Anaheim	California
United States	Novo Nordisk Clinical Trial Call Center	Bradenton	Florida
United States	Novo Nordisk Clinical Trial Call Center	Buckley	Michigan
United States	Novo Nordisk Clinical Trial Call Center	Crystal Lake	Illinois
United States	Novo Nordisk Clinical Trial Call Center	Fort Worth	Texas
United States	Novo Nordisk Clinical Trial Call Center	Greenbrae	California
United States	Novo Nordisk Clinical Trial Call Center	Indianapolis	Indiana
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Plantation	Florida
United States	Novo Nordisk Clinical Trial Call Center	San Diego	California
United States	Novo Nordisk Clinical Trial Call Center	Slidell	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Spring Valley	California
United States	Novo Nordisk Clinical Trial Call Center	Tacoma	Washington
United States	Novo Nordisk Clinical Trial Call Center	Toms River	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  Malaysia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, week 26	No
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs)	A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.	During 26 weeks of treatment	No
Secondary	Number of Treatment Emergent Hypoglycaemic Episodes	Confirmed hypoglycaemic episodes were defined as episodes that are either: severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or; biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.	During 26 weeks of treatment	No
Secondary	Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes	Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).	During 26 weeks of treatment	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.	Week 0, week 26	No

External Links

•   Clinical Trials at Novo Nordisk