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)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Porto Alegre, Brasilien, 90035-170
- Novo Nordisk Investigational Site
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São Paulo, Brasilien, 04022-002
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Sao Paulo
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São Paulo, Sao Paulo, Brasilien, 01244-030
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Quebec, Canada, G3K 2P8
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Alberta
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Calgary, Alberta, Canada, T2N 4L7
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British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
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Surrey, British Columbia, Canada, V3S 2N6
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Victoria, British Columbia, Canada, V8V 4A1
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Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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London, Ontario, Canada, N5W 6A2
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London, Ontario, Canada, N6P 1A9
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Newmarket, Ontario, Canada, L3Y 5G8
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Sarnia, Ontario, Canada, N7T 4X3
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Strathroy, Ontario, Canada, N7G 1Y7
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Quebec
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Trois Rivieres, Quebec, Canada, G8T7A1
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California
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Anaheim, California, Forenede Stater, 92801
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Lomita, California, Forenede Stater, 90717
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Los Angeles, California, Forenede Stater, 90057
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Colorado
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Golden, Colorado, Forenede Stater, 80401
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Florida
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Clearwater, Florida, Forenede Stater, 33765
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Illinois
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Chicago, Illinois, Forenede Stater, 60607
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Kentucky
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Crestview Hills, Kentucky, Forenede Stater, 41017-3464
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70002
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Michigan
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Troy, Michigan, Forenede Stater, 48098
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03063
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New Jersey
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Toms River, New Jersey, Forenede Stater, 08755-8050
- Novo Nordisk Investigational Site
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New York
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Smithtown, New York, Forenede Stater, 11787
- Novo Nordisk Investigational Site
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South Carolina
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Simpsonville, South Carolina, Forenede Stater, 29681
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Tennessee
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Jackson, Tennessee, Forenede Stater, 38305
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Texas
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Dallas, Texas, Forenede Stater, 75230
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Virginia
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Newport News, Virginia, Forenede Stater, 23606
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53142
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Anhui
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Hefei, Anhui, Kina, 230001
- Novo Nordisk Investigational Site
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Beijing
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Beijing, Beijing, Kina, 100029
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Beijing, Beijing, Kina, 100730
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Beijing, Beijing, Kina, 100853
- Novo Nordisk Investigational Site
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Beijing, Beijing, Kina, 100700
- Novo Nordisk Investigational Site
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Beijing, Beijing, Kina, 100039
- Novo Nordisk Investigational Site
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Beijing, Beijing, Kina, 100191
- Novo Nordisk Investigational Site
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Chongqing
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ChongQing, Chongqing, Kina, 404000
- Novo Nordisk Investigational Site
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Chongqing, Chongqing, Kina, 400010
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Chongqing, Chongqing, Kina, 400016
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Fujian
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Fuzhou, Fujian, Kina, 350025
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
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Guangxi
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Nanning, Guangxi, Kina, 530007
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Guizhou
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Guiyang, Guizhou, Kina, 550004
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Hebei
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Shijiazhuang, Hebei, Kina, 050051
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Shijiazhuang, Hebei, Kina, 050082
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150086
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Hubei
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Wuhan, Hubei, Kina, 430034
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Wuhan, Hubei, Kina, 430030
- Novo Nordisk Investigational Site
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Hunan
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Yueyang, Hunan, Kina, 414000
- Novo Nordisk Investigational Site
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Jiangsu
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Yangzhou, Jiangsu, Kina, 225001
- Novo Nordisk Investigational Site
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Zhenjiang, Jiangsu, Kina, 212001
- Novo Nordisk Investigational Site
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Novo Nordisk Investigational Site
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Jilin
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Changchun, Jilin, Kina, 130041
- Novo Nordisk Investigational Site
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Siping, Jilin, Kina, 136000
- Novo Nordisk Investigational Site
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Liaoning
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Shenyang, Liaoning, Kina, 110021
- Novo Nordisk Investigational Site
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Shenyang, Liaoning, Kina, 110004
- Novo Nordisk Investigational Site
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Shaanxi
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Xi'an, Shaanxi, Kina, 710032
- Novo Nordisk Investigational Site
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Shanghai
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Shanghai, Shanghai, Kina, 200040
- Novo Nordisk Investigational Site
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Shanghai, Shanghai, Kina, 200072
- Novo Nordisk Investigational Site
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Yunnan
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Kunming, Yunnan, Kina, 650101
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
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Wenzhou, Zhejiang, Kina, 325000
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Bucharest, Rumænien, 020614
- Novo Nordisk Investigational Site
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Buzau, Rumænien, 120203
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Galati, Rumænien, 800578
- Novo Nordisk Investigational Site
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Sibiu, Rumænien, 550176
- Novo Nordisk Investigational Site
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Bihor
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Oradea, Bihor, Rumænien, 410469
- Novo Nordisk Investigational Site
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Eastern Cape
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George, Eastern Cape, Sydafrika, 6529
- Novo Nordisk Investigational Site
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Gauteng
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Johannesburg, Gauteng, Sydafrika, 2193
- Novo Nordisk Investigational Site
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Johannesburg, Gauteng, Sydafrika, 1812
- Novo Nordisk Investigational Site
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sydafrika, 4001
- Novo Nordisk Investigational Site
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Durban, KwaZulu-Natal, Sydafrika, 4091
- Novo Nordisk Investigational Site
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Dnepropetrovsk, Ukraine, 49005
- Novo Nordisk Investigational Site
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Dnepropetrovsk, Ukraine, 49038
- Novo Nordisk Investigational Site
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Kiev, Ukraine, 04114
- Novo Nordisk Investigational Site
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Mykolaiv, Ukraine, 54003
- Novo Nordisk Investigational Site
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Vinnitsa, Ukraine, 21010
- Novo Nordisk Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NN1250-3587
- U1111-1121-5325 (Anden identifikator: WHO)
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