A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Porto Alegre, Brazílie, 90035-170
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São Paulo, Brazílie, 04022-002
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Sao Paulo
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São Paulo, Sao Paulo, Brazílie, 01244-030
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Eastern Cape
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George, Eastern Cape, Jižní Afrika, 6529
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Gauteng
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Johannesburg, Gauteng, Jižní Afrika, 2193
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Johannesburg, Gauteng, Jižní Afrika, 1812
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Jižní Afrika, 4001
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Durban, KwaZulu-Natal, Jižní Afrika, 4091
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Quebec, Kanada, G3K 2P8
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Alberta
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Calgary, Alberta, Kanada, T2N 4L7
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British Columbia
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Burnaby, British Columbia, Kanada, V5G 1T4
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Surrey, British Columbia, Kanada, V3S 2N6
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Victoria, British Columbia, Kanada, V8V 4A1
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Ontario
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Burlington, Ontario, Kanada, L7M 4Y1
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London, Ontario, Kanada, N5W 6A2
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London, Ontario, Kanada, N6P 1A9
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Newmarket, Ontario, Kanada, L3Y 5G8
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Sarnia, Ontario, Kanada, N7T 4X3
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Strathroy, Ontario, Kanada, N7G 1Y7
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Quebec
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Trois Rivieres, Quebec, Kanada, G8T7A1
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Bucharest, Rumunsko, 020614
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Buzau, Rumunsko, 120203
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Galati, Rumunsko, 800578
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Sibiu, Rumunsko, 550176
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Bihor
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Oradea, Bihor, Rumunsko, 410469
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California
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Anaheim, California, Spojené státy, 92801
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Lomita, California, Spojené státy, 90717
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Los Angeles, California, Spojené státy, 90057
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Colorado
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Golden, Colorado, Spojené státy, 80401
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Florida
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Clearwater, Florida, Spojené státy, 33765
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Illinois
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Chicago, Illinois, Spojené státy, 60607
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Kentucky
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Crestview Hills, Kentucky, Spojené státy, 41017-3464
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Louisiana
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Metairie, Louisiana, Spojené státy, 70002
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Michigan
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Troy, Michigan, Spojené státy, 48098
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Missouri
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Chesterfield, Missouri, Spojené státy, 63017
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New Hampshire
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Nashua, New Hampshire, Spojené státy, 03063
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New Jersey
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Toms River, New Jersey, Spojené státy, 08755-8050
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New York
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Smithtown, New York, Spojené státy, 11787
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South Carolina
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Simpsonville, South Carolina, Spojené státy, 29681
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Tennessee
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Jackson, Tennessee, Spojené státy, 38305
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Texas
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Dallas, Texas, Spojené státy, 75230
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Virginia
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Newport News, Virginia, Spojené státy, 23606
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Wisconsin
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Kenosha, Wisconsin, Spojené státy, 53142
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Dnepropetrovsk, Ukrajina, 49005
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Dnepropetrovsk, Ukrajina, 49038
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Kiev, Ukrajina, 04114
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Mykolaiv, Ukrajina, 54003
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Vinnitsa, Ukrajina, 21010
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Anhui
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Hefei, Anhui, Čína, 230001
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Beijing
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Beijing, Beijing, Čína, 100029
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Beijing, Beijing, Čína, 100730
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Beijing, Beijing, Čína, 100853
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Beijing, Beijing, Čína, 100700
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Beijing, Beijing, Čína, 100039
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Beijing, Beijing, Čína, 100191
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Chongqing
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ChongQing, Chongqing, Čína, 404000
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Chongqing, Chongqing, Čína, 400010
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Chongqing, Chongqing, Čína, 400016
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Fujian
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Fuzhou, Fujian, Čína, 350025
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Guangdong
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Guangzhou, Guangdong, Čína, 510120
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Guangxi
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Nanning, Guangxi, Čína, 530007
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Guizhou
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Guiyang, Guizhou, Čína, 550004
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Hebei
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Shijiazhuang, Hebei, Čína, 050051
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Shijiazhuang, Hebei, Čína, 050082
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Heilongjiang
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Harbin, Heilongjiang, Čína, 150086
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Hubei
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Wuhan, Hubei, Čína, 430034
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Wuhan, Hubei, Čína, 430030
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Hunan
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Yueyang, Hunan, Čína, 414000
- Novo Nordisk Investigational Site
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Jiangsu
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Yangzhou, Jiangsu, Čína, 225001
- Novo Nordisk Investigational Site
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Zhenjiang, Jiangsu, Čína, 212001
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Jiangxi
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Nanchang, Jiangxi, Čína, 330006
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Jilin
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Changchun, Jilin, Čína, 130041
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Siping, Jilin, Čína, 136000
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Liaoning
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Shenyang, Liaoning, Čína, 110021
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Shenyang, Liaoning, Čína, 110004
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Shaanxi
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Xi'an, Shaanxi, Čína, 710032
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Shanghai
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Shanghai, Shanghai, Čína, 200040
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Shanghai, Shanghai, Čína, 200072
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Yunnan
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Kunming, Yunnan, Čína, 650101
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310003
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Wenzhou, Zhejiang, Čína, 325000
- Novo Nordisk Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
- Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
- HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) below or equal to 40.0 kg/m^2
Exclusion Criteria:
- Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
- Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
- Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
- Known or suspected hypersensitivity to trial product(s) or related products
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Insulin Degludec
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Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
Ostatní jména:
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Experimentální: Insulin Glargine
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Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Časové okno: Week 0, week 26
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Change from baseline in HbA1c (%) after 26 weeks of treatment.
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Week 0, week 26
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Časové okno: On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
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Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).
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On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
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Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
Časové okno: Week 0, week 26
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Change from baseline in FPG after 26 weeks of treatment.
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Week 0, week 26
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Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
Časové okno: Week 26
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Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
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Week 26
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Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
Časové okno: Week 26
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A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.
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Week 26
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Number of Treatment Emergent AEs (Adverse Events)
Časové okno: On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
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Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
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On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Pan C, Gross JL, Yang W, Lv X, Sun L, Hansen CT, Xu H, Wagner R. A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin Degludec and Insulin Glargine in Insulin-Naive Patients with Type 2 Diabetes Mellitus. Drugs R D. 2016 Jun;16(2):239-49. doi: 10.1007/s40268-016-0134-z.
- Mu YM, Guo LX, Li L, Li YM, Xu XJ, Li QM, Xu MT, Zhu LY, Yuan GY, Liu Y, Xu C, Wang ZJ, Shen FX, Luo Y, Liu JY, Li QF, Wang WH, Lai XY, Xu HF, Pan CY. [The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial]. Zhonghua Nei Ke Za Zhi. 2017 Sep 1;56(9):660-666. doi: 10.3760/cma.j.issn.0578-1426.2017.09.008. Chinese.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- NN1250-3587
- U1111-1121-5325 (Jiný identifikátor: WHO)
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