A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)

• ClinicalTrials.gov Identifier: NCT01059812
• Recruitment Status: Completed
• First Posted: February 1, 2010
• Results First Posted: November 20, 2015
• Last Update Posted: December 20, 2018
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Condition or disease	Intervention/treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)
• Actual Study Start Date: February 1, 2010
• Actual Primary Completion Date: December 23, 2010
• Actual Study Completion Date: December 23, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: IDegAsp BID	Drug: insulin degludec/insulin aspart; Injected subcutaneously twice daily. Dose was individually adjusted.
Active Comparator: BIAsp 30 BID	Drug: biphasic insulin aspart 30; Injected subcutaneously twice daily. Dose was individually adjusted.

Outcome Measures

Primary Outcome Measures :

1. Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment [ Time Frame: Week 0, Week 26 ]
   Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures :

1. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 [ Time Frame: Week 26 ]
   Mean of 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.
2. 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.
3. 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
4. Change in Body Weight [ Time Frame: Week 0, Week 26 ]
   Change from baseline in body weight after 26 weeks of treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female at least 18 years of age (at least 20 years for Japan)
• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
• HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
• Body mass index (BMI) maximum 35.0 kg/m^2

Exclusion Criteria:

• Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
• Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
• Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
• Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Contacts and Locations

Locations

Hong Kong

Novo Nordisk Investigational Site

Shatin, New Territories, Hong Kong

Japan

Novo Nordisk Investigational Site

Chuo-ku,, Japan, 104 0061

Novo Nordisk Investigational Site

Imizu-shi, Japan, 939 0363

Novo Nordisk Investigational Site

Kamakura-shi, Japan, 247 0056

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, Japan, 582-0005

Novo Nordisk Investigational Site

Koriyama-shi, Fukushima, Japan, 963-8851

Novo Nordisk Investigational Site

Kumamoto-shi, Kumamoto, Japan, 862-0976

Novo Nordisk Investigational Site

Matsumoto-shi, Japan, 390 8510

Novo Nordisk Investigational Site

Naha-shi,, Japan, 900 0032

Novo Nordisk Investigational Site

Naka-shi, Ibaraki, Japan, 311-0113

Novo Nordisk Investigational Site

Oita-shi, Japan, 870 0039

Novo Nordisk Investigational Site

Oyama-shi, Tochigi, Japan, 323-0022

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, Japan, 060-0062

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, Japan, 062-0007

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, Japan, 569-1096

Novo Nordisk Investigational Site

Urasoe-shi,, Japan, 901 2104

Novo Nordisk Investigational Site

Yokohama-shi, Kanagawa, Japan, 235-0045

Korea, Republic of

Novo Nordisk Investigational Site

Ansan, Korea, Republic of, 152-703

Novo Nordisk Investigational Site

Daegu, Korea, Republic of, 705-717

Novo Nordisk Investigational Site

Daegu, Korea, Republic of, 705-718

Novo Nordisk Investigational Site

Guri, Korea, Republic of, 471-101

Novo Nordisk Investigational Site

Gyeonggi, Korea, Republic of, 480-717

Novo Nordisk Investigational Site

Incheon, Korea, Republic of, 400-103

Novo Nordisk Investigational Site

Incheon, Korea, Republic of, 405-760

Novo Nordisk Investigational Site

Jeollanamdo, Korea, Republic of, 501-717

Novo Nordisk Investigational Site

Pusan, Korea, Republic of, 602-739

Novo Nordisk Investigational Site

Seongnam-si, Korea, Republic of, 463-707

Novo Nordisk Investigational Site

Seoul, Korea, Republic of, 02447

Novo Nordisk Investigational Site

Seoul, Korea, Republic of, 02841

Novo Nordisk Investigational Site

Seoul, Korea, Republic of, 120-752

Novo Nordisk Investigational Site

Seoul, Korea, Republic of, 134-701

Novo Nordisk Investigational Site

Suwon, Korea, Republic of, 16499

Novo Nordisk Investigational Site

Wonju, Korea, Republic of, 220-701

Malaysia

Novo Nordisk Investigational Site

Cheras, Malaysia, 56000

Novo Nordisk Investigational Site

Georgetown, Penang, Malaysia, 10450

Novo Nordisk Investigational Site

Johor Bahru, Malaysia, 80100

Novo Nordisk Investigational Site

Klang, Selangor, Malaysia, 41200

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, Malaysia, 16150

Novo Nordisk Investigational Site

Kota Kinabalu, Malaysia, 88586

Novo Nordisk Investigational Site

Putrajaya, Malaysia, 62250

Novo Nordisk Investigational Site

Seremban, Malaysia, 70300

Taiwan

Novo Nordisk Investigational Site

Kaohsiung City, Taiwan, 833

Novo Nordisk Investigational Site

Taichung, Taiwan, 404

Novo Nordisk Investigational Site

Tainan city, Taiwan, 710

Novo Nordisk Investigational Site

Taipei, Taiwan, 100

Novo Nordisk Investigational Site

Taipei, Taiwan, 112

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Publications of Results:

Evans M, Gundgaard J, Hansen BB. Cost-Effectiveness of Insulin Degludec/Insulin Aspart Versus Biphasic Insulin Aspart in Patients with Type 2 Diabetes from a Danish Health-Care Perspective. Diabetes Ther. 2016 Dec;7(4):809-823. Epub 2016 Aug 23.

Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016 Sep;8(5):720-8. doi: 10.1111/1753-0407.12355. Epub 2016 Mar 6.

Taneda S, Hyllested-Winge J, Gall MA, Kaneko S, Hirao K. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017 Mar;9(3):243-247. doi: 10.1111/1753-0407.12407. Epub 2016 Jul 7.

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 haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.

Fulcher G, Mehta R, Fita EG, Ekelund M, Bain SC. Efficacy and Safety of IDegAsp Versus BIAsp 30, Both Twice Daily, in Elderly Patients with Type 2 Diabetes: Post Hoc Analysis of Two Phase 3 Randomized Controlled BOOST Trials. Diabetes Ther. 2019 Feb;10(1):107-118. doi: 10.1007/s13300-018-0531-0. Epub 2018 Nov 24.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang W, Akhtar S, Franek E, Haluzík M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Jan 19. doi: 10.1007/s13300-021-01196-7. [Epub ahead of print]

Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y, Andersen TH, Gall MA, Christiansen JS; BOOST: Intensify All Trial Investigators. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract. 2015 Jan;107(1):139-47. doi: 10.1016/j.diabres.2014.09.026. Epub 2014 Oct 14.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01059812
• Other Study ID Numbers: NN5401-3597; U1111-1111-7210 ( Other Identifier: WHO ); 101040 ( Registry Identifier: JAPIC )
• First Posted: February 1, 2010
• Results First Posted: November 20, 2015
• Last Update Posted: December 20, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Hypoglycemic Agents; Physiological Effects of Drugs