Diabetes Mellitus, Type 2 Clinical Trial
— BOOST™Official title:
A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)
| Verified date | November 2018 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 424 |
| Est. completion date | December 23, 2010 |
| Est. primary completion date | December 23, 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Novo Nordisk Investigational Site | Shatin, New Territories | |
| Japan | Novo Nordisk Investigational Site | Chuo-ku, | |
| Japan | Novo Nordisk Investigational Site | Imizu-shi | |
| Japan | Novo Nordisk Investigational Site | Kamakura-shi | |
| Japan | Novo Nordisk Investigational Site | Kashiwara-shi, Osaka | |
| Japan | Novo Nordisk Investigational Site | Koriyama-shi, Fukushima | |
| Japan | Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto | |
| Japan | Novo Nordisk Investigational Site | Matsumoto-shi | |
| Japan | Novo Nordisk Investigational Site | Naha-shi, | |
| Japan | Novo Nordisk Investigational Site | Naka-shi, Ibaraki | |
| Japan | Novo Nordisk Investigational Site | Oita-shi | |
| Japan | Novo Nordisk Investigational Site | Oyama-shi, Tochigi | |
| Japan | Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | |
| Japan | Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | |
| Japan | Novo Nordisk Investigational Site | Takatsuki-shi, Osaka | |
| Japan | Novo Nordisk Investigational Site | Urasoe-shi, | |
| Japan | Novo Nordisk Investigational Site | Yokohama-shi, Kanagawa | |
| Korea, Republic of | Novo Nordisk Investigational Site | Ansan | |
| Korea, Republic of | Novo Nordisk Investigational Site | Daegu | |
| Korea, Republic of | Novo Nordisk Investigational Site | Daegu | |
| Korea, Republic of | Novo Nordisk Investigational Site | Guri | |
| Korea, Republic of | Novo Nordisk Investigational Site | Gyeonggi | |
| Korea, Republic of | Novo Nordisk Investigational Site | Incheon | |
| Korea, Republic of | Novo Nordisk Investigational Site | Incheon | |
| Korea, Republic of | Novo Nordisk Investigational Site | Jeollanamdo | |
| Korea, Republic of | Novo Nordisk Investigational Site | Pusan | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seongnam-si | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul | |
| Korea, Republic of | Novo Nordisk Investigational Site | Suwon | |
| Korea, Republic of | Novo Nordisk Investigational Site | Wonju | |
| Malaysia | Novo Nordisk Investigational Site | Cheras | |
| Malaysia | Novo Nordisk Investigational Site | Georgetown, Penang | |
| Malaysia | Novo Nordisk Investigational Site | Johor Bahru | |
| Malaysia | Novo Nordisk Investigational Site | Klang, Selangor | |
| Malaysia | Novo Nordisk Investigational Site | Kota Bharu, Kelantan | |
| Malaysia | Novo Nordisk Investigational Site | Kota Kinabalu | |
| Malaysia | Novo Nordisk Investigational Site | Putrajaya | |
| Malaysia | Novo Nordisk Investigational Site | Seremban | |
| Taiwan | Novo Nordisk Investigational Site | Kaohsiung City | |
| Taiwan | Novo Nordisk Investigational Site | Taichung | |
| Taiwan | Novo Nordisk Investigational Site | Tainan city | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| Taiwan | Novo Nordisk Investigational Site | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Hong Kong, Japan, Korea, Republic of, Malaysia, Taiwan,
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 diabete — View Citation
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. — View Citation
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. 2018 Nov 24. d — 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
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-t — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment | Change from baseline in HbA1c after 26 weeks of treatment. | Week 0, Week 26 | |
| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at 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. | Week 26 | |
| Secondary | Rate of Confirmed Hypoglycaemic Episodes | 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. | Week 0 to Week 26 + 7 days follow up | |
| Secondary | Rate of Nocturnal Confirmed Hypoglycaemic Episodes | 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. | Week 0 to Week 26 + 7 days follow up | |
| Secondary | Change in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | Week 0, Week 26 |
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