Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™)
9. februar 2017 opdateret af: Novo Nordisk A/S
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™: JAPAN)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
296
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Asahikawa-shi, Hokkaido, Japan, 070 0002
- Novo Nordisk Investigational Site
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Chigasaki-shi, Kanagawa, Japan, 253 0052
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japan, 103 0027
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japan, 103 0002
- Novo Nordisk Investigational Site
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Ebina-shi, Japan, 243 0432
- Novo Nordisk Investigational Site
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Fukuoka-shi, Fukuoka, Japan, 815 8555
- Novo Nordisk Investigational Site
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Iruma-shi, Saitama, Japan, 358 0003
- Novo Nordisk Investigational Site
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Izumisano-shi, Japan, 598 0048
- Novo Nordisk Investigational Site
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Kamakura-shi, Japan, 247 0056
- Novo Nordisk Investigational Site
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Kanagawa-shi, Yokohama, Japan, 221 0802
- Novo Nordisk Investigational Site
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Kashiwa-shi, Chiba, Japan, 277 0825
- Novo Nordisk Investigational Site
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Kashiwara-shi, Osaka, Japan, 582 0005
- Novo Nordisk Investigational Site
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Katsushika-ku, Tokyo, Japan, 125 0054
- Novo Nordisk Investigational Site
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Kawagoe-shi, Saitama, Japan, 350 0851
- Novo Nordisk Investigational Site
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Kitakyushu-shi, Fukuoka, Japan, 800 0252
- Novo Nordisk Investigational Site
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Koriyama-shi, Fukushima, Japan, 963 8851
- Novo Nordisk Investigational Site
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Kumamoto-shi, Kumamoto, Japan, 861 8045
- Novo Nordisk Investigational Site
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Kumamoto-shi,Kumamoto, Japan, 862 0976
- Novo Nordisk Investigational Site
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Kurume-shi, Fukuoka, Japan, 839 0863
- Novo Nordisk Investigational Site
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Kurume-shi, Fukuoka, Japan, 830 8577
- Novo Nordisk Investigational Site
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Kyoto-shi, Kyoto, Japan, 615 8125
- Novo Nordisk Investigational Site
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Matsumoto-shi, Nagano, Japan, 399 0006
- Novo Nordisk Investigational Site
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Miyazaki-shi, Japan, 880 0034
- Novo Nordisk Investigational Site
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Naha-shi,, Japan, 900 0032
- Novo Nordisk Investigational Site
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Naka-shi, Ibaraki, Japan, 311 0113
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hygo, Japan, 662 0971
- Novo Nordisk Investigational Site
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Obihiro-shi, Hokkaido, Japan, 080 0016
- Novo Nordisk Investigational Site
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Obihiro-shi, Hokkaido, Japan, 080 0848
- Novo Nordisk Investigational Site
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Ogawa-machi, Japan, 355 0321
- Novo Nordisk Investigational Site
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Oita-shi, Japan, 870 0039
- Novo Nordisk Investigational Site
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Okawa-shi, Fukuoka, Japan, 831 0016
- Novo Nordisk Investigational Site
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Ota-ku, Tokyo, Japan, 144 0035
- Novo Nordisk Investigational Site
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Oyama-shi, Tochigi, Japan, 323 0022
- Novo Nordisk Investigational Site
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Sapporo, Hokkaido, Japan, 060 0033
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japan, 060 0062
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japan, 060-0001
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japan, 062 0007
- Novo Nordisk Investigational Site
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Sappro-shi, Hokkaido, Japan, 060 8648
- Novo Nordisk Investigational Site
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Sasebo-shi, Nagasaki, Japan, 857 1165
- Novo Nordisk Investigational Site
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Sendai-shi, Japan, 980 0021
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japan, 329 0433
- Novo Nordisk Investigational Site
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Shizuoka-shi, Japan, 424 0853
- Novo Nordisk Investigational Site
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Tagajo-shi, Japan, 985 0852
- Novo Nordisk Investigational Site
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Tagawa-shi, Fukuoka, Japan, 825 8567
- Novo Nordisk Investigational Site
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Takatsuki-shi, Osaka, Japan, 569 1096
- Novo Nordisk Investigational Site
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Tamana-shi, Kumamoto, Japan, 865 0064
- Novo Nordisk Investigational Site
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Tokyo, Japan, 167 0043
- Novo Nordisk Investigational Site
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Tsuchiura-shi, Ibaraki, Japan, 300 0832
- Novo Nordisk Investigational Site
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Urasoe-shi,, Japan, 901 2104
- Novo Nordisk Investigational Site
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Yokohama-shi, Kanagawa, Japan, 227 0054
- Novo Nordisk Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: IDegAsp OD
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Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
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Aktiv komparator: IGlar OD
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Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Glycosylated Haemoglobin (HbA1c)
Tidsramme: Week 0, Week 26
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Observed change from baseline in HbA1c after 26 weeks of treatment
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Week 0, Week 26
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Frekvens for behandlingsmæssige uønskede hændelser (AE'er)
Tidsramme: Uge 0 til uge 26 + 7 dages opfølgning
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Svarer til frekvensen af AE'er pr. 100 patientårs eksponering.
Sværhedsgrad vurderet af efterforsker.
Mild: ingen eller forbigående symptomer, ingen forstyrrelse af forsøgspersonens daglige aktiviteter.
Moderat: markante symptomer, moderat interferens med forsøgspersonens daglige aktiviteter.
Alvorlig: betydelig forstyrrelse af forsøgspersonens daglige aktiviteter, uacceptabel.
Alvorlig AE: AE, der ved enhver dosis resulterer i et af følgende: død, en livstruende oplevelse, indlæggelse hos patienten/forlængelse af eksisterende hospitalsindlæggelse, vedvarende/betydelig invaliditet/inhabilitet/medfødt anomali/fødselsdefekt.
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Uge 0 til uge 26 + 7 dages opfølgning
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Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal
Tidsramme: Week 26
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Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal
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Week 26
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Rate of Confirmed Hypoglycaemic Episodes
Tidsramme: Week 0 to Week 26 + 7 days follow up
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Observed 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 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.
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Week 0 to Week 26 + 7 days follow up
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Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Tidsramme: Week 0 to Week 26 + 7 days follow up
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Observed 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 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 a.m.
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Week 0 to Week 26 + 7 days follow up
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Change in Body Weight
Tidsramme: Week 0, Week 26
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Observed change from baseline in body weight after 26 weeks of treatment
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Week 0, Week 26
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. september 2011
Studieafslutning (Faktiske)
1. september 2011
Datoer for studieregistrering
Først indsendt
6. januar 2011
Først indsendt, der opfyldte QC-kriterier
6. januar 2011
Først opslået (Skøn)
7. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN5401-3896
- U1111-1118-0124 (Anden identifikator: WHO)
- JapicCTI-111385 (Registry Identifier: JAPIC)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .