Clinical trial NCT01272193: Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Official title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 296
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria:

* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
* Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
* 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

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
timeFrame: Week 26
measure: Rate of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Rate of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Rate of Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 26 + 7 days follow up
measure: Change in Body Weight
timeFrame: Week 0, Week 26
Other outcomes:
Locations:
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Chigasaki-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Iruma-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Izumisano-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kamakura-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Kanagawa-shi, Yokohama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwa-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Katsushika-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawagoe-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kitakyushu-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi, Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Kurume-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kurume-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kyoto-shi, Kyoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Matsumoto-shi, Nagano
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Naha-shi,
country: Japan
facility: Novo Nordisk Investigational Site
city: Naka-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishinomiya-shi, Hygo
country: Japan
facility: Novo Nordisk Investigational Site
city: Obihiro-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Obihiro-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Ogawa-machi
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Okawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sappro-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sasebo-shi, Nagasaki
country: Japan
facility: Novo Nordisk Investigational Site
city: Sendai-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tagajo-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tagawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Takatsuki-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tamana-shi, Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tsuchiura-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Urasoe-shi,
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.
citation: Yang W, Akhtar S, Franek E, Haluzik 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 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.