Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)
A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)
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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Burgas, Bulgarien, 8000
- Novo Nordisk Investigational Site
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Ruse, Bulgarien, 7000
- Novo Nordisk Investigational Site
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Sofia, Bulgarien, 1606
- Novo Nordisk Investigational Site
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Stara Zagora, Bulgarien, 6000
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Quebec, Canada, G1V 4G5
- Novo Nordisk Investigational Site
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Quebec, Canada, G1N 4V3
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Quebec, Canada, G3K 2P8
- Novo Nordisk Investigational Site
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British Columbia
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Chilliwack, British Columbia, Canada, V2P 4M9
- Novo Nordisk Investigational Site
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Ontario
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Ottawa, Ontario, Canada, K1K 4L2
- Novo Nordisk Investigational Site
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M5C 2T2
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Alabama
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Birmingham, Alabama, Forenede Stater, 35216
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Arizona
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Peoria, Arizona, Forenede Stater, 85381
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Tucson, Arizona, Forenede Stater, 85712
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California
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Beverly Hills, California, Forenede Stater, 90211
- Novo Nordisk Investigational Site
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Escondido, California, Forenede Stater, 92025
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La Jolla, California, Forenede Stater, 92037
- Novo Nordisk Investigational Site
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Los Angeles, California, Forenede Stater, 90057
- Novo Nordisk Investigational Site
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Los Banos, California, Forenede Stater, 93635
- Novo Nordisk Investigational Site
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Monterey, California, Forenede Stater, 93940
- Novo Nordisk Investigational Site
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Palm Springs, California, Forenede Stater, 92262
- Novo Nordisk Investigational Site
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Pasadena, California, Forenede Stater, 91105
- Novo Nordisk Investigational Site
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Redondo Beach, California, Forenede Stater, 90277
- Novo Nordisk Investigational Site
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San Mateo, California, Forenede Stater, 94401
- Novo Nordisk Investigational Site
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Tarzana, California, Forenede Stater, 91356-3551
- Novo Nordisk Investigational Site
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Tustin, California, Forenede Stater, 92780
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Colorado
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Denver, Colorado, Forenede Stater, 80209
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Golden, Colorado, Forenede Stater, 80401
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Florida
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Boynton Beach, Florida, Forenede Stater, 33472
- Novo Nordisk Investigational Site
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DeLand, Florida, Forenede Stater, 32720
- Novo Nordisk Investigational Site
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Kissimmee, Florida, Forenede Stater, 34741
- Novo Nordisk Investigational Site
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Miami, Florida, Forenede Stater, 33156
- Novo Nordisk Investigational Site
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Orange Park, Florida, Forenede Stater, 32073
- Novo Nordisk Investigational Site
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Plantation, Florida, Forenede Stater, 33324
- Novo Nordisk Investigational Site
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Tampa, Florida, Forenede Stater, 33613
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West Palm Beach, Florida, Forenede Stater, 33401
- Novo Nordisk Investigational Site
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Georgia
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Conyers, Georgia, Forenede Stater, 30094-5965
- Novo Nordisk Investigational Site
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Dunwoody, Georgia, Forenede Stater, 30338
- Novo Nordisk Investigational Site
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60004-2315
- Novo Nordisk Investigational Site
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Chicago, Illinois, Forenede Stater, 60607
- Novo Nordisk Investigational Site
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Chicago, Illinois, Forenede Stater, 60622
- Novo Nordisk Investigational Site
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Springfield, Illinois, Forenede Stater, 62711
- Novo Nordisk Investigational Site
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Kansas
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Wichita, Kansas, Forenede Stater, 67205
- Novo Nordisk Investigational Site
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Kentucky
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Crestview Hills, Kentucky, Forenede Stater, 41017-3464
- Novo Nordisk Investigational Site
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Madisonville, Kentucky, Forenede Stater, 42431
- Novo Nordisk Investigational Site
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70002
- Novo Nordisk Investigational Site
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Maryland
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Glen Burnie, Maryland, Forenede Stater, 21061
- Novo Nordisk Investigational Site
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Reisterstown, Maryland, Forenede Stater, 21136-2516
- Novo Nordisk Investigational Site
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Silver Spring, Maryland, Forenede Stater, 20910
- Novo Nordisk Investigational Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0482
- Novo Nordisk Investigational Site
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Minnesota
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Eagan, Minnesota, Forenede Stater, 55123
- 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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Staten Island, New York, Forenede Stater, 10301
- Novo Nordisk Investigational Site
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Novo Nordisk Investigational Site
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Burlington, North Carolina, Forenede Stater, 27215-8700
- Novo Nordisk Investigational Site
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Whiteville, North Carolina, Forenede Stater, 28472
- Novo Nordisk Investigational Site
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Winston Salem, North Carolina, Forenede Stater, 27103
- Novo Nordisk Investigational Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45255
- Novo Nordisk Investigational Site
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Dayton, Ohio, Forenede Stater, 45406
- Novo Nordisk Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, Forenede Stater, 16602
- Novo Nordisk Investigational Site
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Altoona, Pennsylvania, Forenede Stater, 16601
- Novo Nordisk Investigational Site
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Harrisburg, Pennsylvania, Forenede Stater, 17112-1900
- Novo Nordisk Investigational Site
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Langhorne, Pennsylvania, Forenede Stater, 19047
- Novo Nordisk Investigational Site
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Rhode Island
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East Providence, Rhode Island, Forenede Stater, 02914
- Novo Nordisk Investigational Site
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South Carolina
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Newberry, South Carolina, Forenede Stater, 29108-2249
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Novo Nordisk Investigational Site
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Kingsport, Tennessee, Forenede Stater, 37660
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, Forenede Stater, 76014
- Novo Nordisk Investigational Site
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Dallas, Texas, Forenede Stater, 75251
- Novo Nordisk Investigational Site
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Houston, Texas, Forenede Stater, 77025
- Novo Nordisk Investigational Site
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Round Rock, Texas, Forenede Stater, 78681
- Novo Nordisk Investigational Site
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Utah
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Ogden, Utah, Forenede Stater, 84403
- Novo Nordisk Investigational Site
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Salt Lake City, Utah, Forenede Stater, 84102
- Novo Nordisk Investigational Site
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Salt Lake City, Utah, Forenede Stater, 84107
- Novo Nordisk Investigational Site
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Virginia
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Chesapeake, Virginia, Forenede Stater, 23320
- Novo Nordisk Investigational Site
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Novo Nordisk Investigational Site
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Spokane, Washington, Forenede Stater, 99218
- Novo Nordisk Investigational Site
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LA ROCHE-sur-YON cedex 9, Frankrig, 85295
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, Frankrig, 17019
- Novo Nordisk Investigational Site
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Le Creusot, Frankrig, 71200
- Novo Nordisk Investigational Site
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Nanterre, Frankrig, 92014
- Novo Nordisk Investigational Site
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Narbonne, Frankrig, 11108
- Novo Nordisk Investigational Site
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Nimes, Frankrig, 30006
- Novo Nordisk Investigational Site
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Paris, Frankrig, 75877
- Novo Nordisk Investigational Site
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Venissieux, Frankrig, 69200
- Novo Nordisk Investigational Site
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Amsterdam, Holland, 1105 AZ
- Novo Nordisk Investigational Site
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Beek, Holland, 6191JW
- Novo Nordisk Investigational Site
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Etten-Leur, Holland, 4872 LP
- Novo Nordisk Investigational Site
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Hengelo, Holland, 7555 DL
- Novo Nordisk Investigational Site
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Hoogeveen, Holland, 7909 AA
- Novo Nordisk Investigational Site
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Lieshout, Holland, 5737 CB
- Novo Nordisk Investigational Site
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Utrecht, Holland, 3582 KE
- Novo Nordisk Investigational Site
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Zwijndrecht, Holland, 3331 LZ
- Novo Nordisk Investigational Site
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Bacau, Rumænien, 600164
- Novo Nordisk Investigational Site
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Botosani, Rumænien, 710224
- Novo Nordisk Investigational Site
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Bucharest, Rumænien, 010816
- Novo Nordisk Investigational Site
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Galati, Rumænien, 800578
- Novo Nordisk Investigational Site
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Satu Mare, Rumænien, 440055
- 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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Budapest, Ungarn, 1125
- Novo Nordisk Investigational Site
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Debrecen, Ungarn, 4043
- Novo Nordisk Investigational Site
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Eger, Ungarn, 3300
- Novo Nordisk Investigational Site
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Gyula, Ungarn, 5700
- Novo Nordisk Investigational Site
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Kaposvar, Ungarn, H-7400
- Novo Nordisk Investigational Site
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Szeged, Ungarn, H-6720
- 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 (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 insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 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 (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) below or equal to 45.0 kg/m^2
Exclusion Criteria:
- Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
- 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 hereof (except basal cell skin cancer or squamous cell skin cancer)
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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Aktiv komparator: IGlar OD
|
Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
|
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Eksperimentel: IDeg 3TW
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Will be injected subcutaneously (under the skin) once daily three times weekly.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i glykosyleret hæmoglobin (HbA1c)
Tidsramme: Uge 0, uge 26
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Ændring fra baseline i HbA1c efter 26 ugers behandling
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Uge 0, uge 26
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Weight
Tidsramme: Week 0, Week 26
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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
Sponsor
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- NN1250-3718
- 2009-011399-31 (EudraCT nummer)
- U1111-1112-8770 (Anden identifikator: WHO)
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 .