Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine

Diabetes Mellitus, Type 2 Clinical Trial

— BOOST®  

Official title:

A Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680341
• Other study ID #: NN5401-3941
• Secondary ID: 2012-000373-23U1
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2012
• Last updated: March 6, 2018
• Start date: August 31, 2012
• Est. completion date: August 22, 2013

Study information

• Verified date: March 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: August 22, 2013
• Est. primary completion date: August 22, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)

• Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time

• Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis

• Body mass index (BMI) below or equal to 40 kg/m^2

Exclusion Criteria:

• Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)

• Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)

• Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg

• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator

• Life-threatening disease (e.g. cancer)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
• insulin degludec/insulin aspart
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Algeria	Novo Nordisk Investigational Site	Oran
Algeria	Novo Nordisk Investigational Site	Tizi Ouzou
Germany	Novo Nordisk Investigational Site	Erdmannhausen
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Neuwied
Germany	Novo Nordisk Investigational Site	Pohlheim
Germany	Novo Nordisk Investigational Site	Rehlingen-Siersburg
Germany	Novo Nordisk Investigational Site	Saint Ingbert
Malaysia	Novo Nordisk Investigational Site	Cheras
Malaysia	Novo Nordisk Investigational Site	Kota Bharu, Kelantan
Malaysia	Novo Nordisk Investigational Site	Selangor
Turkey	Novo Nordisk Investigational Site	Antalya
Turkey	Novo Nordisk Investigational Site	Denizli
Turkey	Novo Nordisk Investigational Site	Gaziantep
Turkey	Novo Nordisk Investigational Site	Hatay
Turkey	Novo Nordisk Investigational Site	Istanbul
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Avon	Illinois
United States	Novo Nordisk Investigational Site	Bradenton	Florida
United States	Novo Nordisk Investigational Site	Buckley	Michigan
United States	Novo Nordisk Investigational Site	Charleston	South Carolina
United States	Novo Nordisk Investigational Site	Crystal Lake	Illinois
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Fort Worth	Texas
United States	Novo Nordisk Investigational Site	Goodyear	Arizona
United States	Novo Nordisk Investigational Site	Greenbrae	California
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Kenosha	Wisconsin
United States	Novo Nordisk Investigational Site	Kissimmee	Florida
United States	Novo Nordisk Investigational Site	Lawrenceville	New Jersey
United States	Novo Nordisk Investigational Site	Myrtle Beach	South Carolina
United States	Novo Nordisk Investigational Site	Nashua	New Hampshire
United States	Novo Nordisk Investigational Site	Olympia	Washington
United States	Novo Nordisk Investigational Site	Plantation	Florida
United States	Novo Nordisk Investigational Site	Saint Petersburg	Florida
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	Slidell	Louisiana
United States	Novo Nordisk Investigational Site	Spring Valley	California
United States	Novo Nordisk Investigational Site	Suwanee	Georgia
United States	Novo Nordisk Investigational Site	Tacoma	Washington
United States	Novo Nordisk Investigational Site	Toms River	New Jersey
United States	Novo Nordisk Investigational Site	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Germany,  Malaysia,  Turkey, 

References & Publications (2)

Bode BW, Buse JB, Fisher M, Garg SK, Marre M, Merker L, Renard E, Russell-Jones DL, Hansen CT, Rana A, Heller SR; BEGIN® Basal-Bolus Type 1 trial investigators. Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insul — View Citation

Haluzík M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglob — View Citation

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
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment	Week 0, Week 26
Secondary	Subjects With HbA1c Below 7.0%	Number of subjects with HbA1c below 7% after 26 weeks of treatment.	Week 26
Secondary	Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia	Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.	Week 26
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs)	A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.	Weeks 0-28
Secondary	Number of Treatment Emergent Confirmed Hypoglycaemic Episodes	Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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.	Weeks 0-27
Secondary	Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period	Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and 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.	From week 16 to end of trial including follow-up (week 27)
Secondary	Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes	Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and 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 am.	Weeks 0-27

External Links

•   Clinical Trials at Novo Nordisk