A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (DUAL™ II)
7. december 2018 opdateret af: Novo Nordisk A/S
A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes
This trial is conducted in Asia, Europe and the United States of America (USA).
The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes.
Subjects continue their pre-trial treatment with metformin throughout the entire trial.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
413
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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Burgas, Bulgarien, 8000
- Novo Nordisk Investigational Site
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Haskovo, Bulgarien, 6300
- Novo Nordisk Investigational Site
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Lukovit, Bulgarien, 5770
- Novo Nordisk Investigational Site
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Plovdiv, Bulgarien, 4001
- Novo Nordisk Investigational Site
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Ruse, Bulgarien, 7000
- Novo Nordisk Investigational Site
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Sofia, Bulgarien, 1712
- Novo Nordisk Investigational Site
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Gentofte, Danmark, 2820
- Novo Nordisk Investigational Site
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Hellerup, Danmark, 2900
- Novo Nordisk Investigational Site
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Århus C, Danmark, 8000
- Novo Nordisk Investigational Site
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Alabama
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Huntsville, Alabama, Forenede Stater, 35801
- Novo Nordisk Investigational Site
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Vestavia Hills, Alabama, Forenede Stater, 35209
- Novo Nordisk Investigational Site
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California
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Anaheim, California, Forenede Stater, 92801
- Novo Nordisk Investigational Site
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Los Angeles, California, Forenede Stater, 90057
- Novo Nordisk Investigational Site
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Tustin, California, Forenede Stater, 92780
- Novo Nordisk Investigational Site
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Ventura, California, Forenede Stater, 93003
- Novo Nordisk Investigational Site
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
- Novo Nordisk Investigational Site
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Novo Nordisk Investigational Site
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Florida
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Melbourne, Florida, Forenede Stater, 32934
- Novo Nordisk Investigational Site
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Miami, Florida, Forenede Stater, 33156
- Novo Nordisk Investigational Site
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Georgia
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Roswell, Georgia, Forenede Stater, 30076
- 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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Avon, Illinois, Forenede Stater, 46123
- Novo Nordisk Investigational Site
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Chicago, Illinois, Forenede Stater, 60607
- Novo Nordisk Investigational Site
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Crystal Lake, Illinois, Forenede Stater, 60012
- Novo Nordisk Investigational Site
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Gurnee, Illinois, Forenede Stater, 60031
- Novo Nordisk Investigational Site
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Indiana
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Greenfield, Indiana, Forenede Stater, 46140
- Novo Nordisk Investigational Site
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Indianapolis, Indiana, Forenede Stater, 46254
- Novo Nordisk Investigational Site
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Muncie, Indiana, Forenede Stater, 47304
- Novo Nordisk Investigational Site
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New Albany, Indiana, Forenede Stater, 47150
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- 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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Metairie, Louisiana, Forenede Stater, 70006-2930
- Novo Nordisk Investigational Site
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Slidell, Louisiana, Forenede Stater, 70461-4231
- Novo Nordisk Investigational Site
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Maryland
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Rockville, Maryland, Forenede Stater, 20852
- Novo Nordisk Investigational Site
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Massachusetts
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Methuen, Massachusetts, Forenede Stater, 01844
- Novo Nordisk Investigational Site
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North Dartmouth, Massachusetts, Forenede Stater, 02747
- Novo Nordisk Investigational Site
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Waltham, Massachusetts, Forenede Stater, 02453
- Novo Nordisk Investigational Site
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Michigan
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Southfield, Michigan, Forenede Stater, 48034-7661
- Novo Nordisk Investigational Site
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
- Novo Nordisk Investigational Site
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Saint Charles, Missouri, Forenede Stater, 63303
- Novo Nordisk Investigational Site
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03063
- Novo Nordisk Investigational Site
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New Jersey
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Lawrenceville, New Jersey, Forenede Stater, 08648
- Novo Nordisk Investigational Site
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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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Albany, New York, Forenede Stater, 12206
- Novo Nordisk Investigational Site
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Smithtown, New York, Forenede Stater, 11787
- Novo Nordisk Investigational Site
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North Carolina
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Asheboro, North Carolina, Forenede Stater, 27203
- Novo Nordisk Investigational Site
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Chapel Hill, North Carolina, Forenede Stater, 27517
- Novo Nordisk Investigational Site
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Greensboro, North Carolina, Forenede Stater, 27408
- Novo Nordisk Investigational Site
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Hickory, North Carolina, Forenede Stater, 28602
- Novo Nordisk Investigational Site
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Statesville, North Carolina, Forenede Stater, 28625
- Novo Nordisk Investigational Site
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Pennsylvania
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Beaver, Pennsylvania, Forenede Stater, 15009
- Novo Nordisk Investigational Site
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Novo Nordisk Investigational Site
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Philadelphia, Pennsylvania, Forenede Stater, 19152
- Novo Nordisk Investigational Site
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South Carolina
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Greer, South Carolina, Forenede Stater, 29651
- Novo Nordisk Investigational Site
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Simpsonville, South Carolina, Forenede Stater, 29681
- Novo Nordisk Investigational Site
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- 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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Austin, Texas, Forenede Stater, 78731
- Novo Nordisk Investigational Site
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Dallas, Texas, Forenede Stater, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, Forenede Stater, 75246
- Novo Nordisk Investigational Site
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Dallas, Texas, Forenede Stater, 75251
- Novo Nordisk Investigational Site
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Hurst, Texas, Forenede Stater, 76054
- Novo Nordisk Investigational Site
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San Antonio, Texas, Forenede Stater, 78229
- Novo Nordisk Investigational Site
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San Antonio, Texas, Forenede Stater, 78215
- Novo Nordisk Investigational Site
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San Antonio, Texas, Forenede Stater, 78224
- Novo Nordisk Investigational Site
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Sugar Land, Texas, Forenede Stater, 77478
- Novo Nordisk Investigational Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84107
- Novo Nordisk Investigational Site
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Dhantoli, Nagpur, Indien, 440012
- Novo Nordisk Investigational Site
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Maharashtra
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Mumbai, Maharashtra, Indien, 400008
- Novo Nordisk Investigational Site
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Mumbai, Maharashtra, Indien, 400053
- Novo Nordisk Investigational Site
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Pune, Maharashtra, Indien, 411001.
- Novo Nordisk Investigational Site
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Tamil Nadu
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Chennai, Tamil Nadu, Indien, 600086
- Novo Nordisk Investigational Site
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West Bengal
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Kolkata, West Bengal, Indien, 700064
- Novo Nordisk Investigational Site
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Basel, Schweiz, 4031
- Novo Nordisk Investigational Site
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Bern, Schweiz, 3010
- Novo Nordisk Investigational Site
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Interlaken-Unterseen, Schweiz, 3800
- Novo Nordisk Investigational Site
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Lausanne, Schweiz, 1011
- Novo Nordisk Investigational Site
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Luzern 16, Schweiz, 6000
- Novo Nordisk Investigational Site
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St. Gallen, Schweiz, 9007
- Novo Nordisk Investigational Site
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Koper, Slovenien, SI-6000
- Novo Nordisk Investigational Site
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Ljubljana, Slovenien, 1525
- Novo Nordisk Investigational Site
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Novo mesto, Slovenien, 8000
- 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, H-3300
- Novo Nordisk Investigational Site
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Szombathely, Ungarn, H-9700
- 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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subjects with type 2 diabetes
- HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
- Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
- BMI (Body Mass Index) more than or equal to 27 kg/m^2
Exclusion Criteria:
- Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
- Impaired liver function
- Impaired renal function
- Screening calcitonin equal to or above 50 ng/l
- Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
- Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
- Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
- Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
- History of chronic pancreatitis or idiopathic acute pancreatitis
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: IDegLira + metformin
IDegLira was injected subcutaneously once daily for 26 weeks.
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IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting).
IDegLira is injected subcutaneously (under the skin) once daily.
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Eksperimentel: IDeg + metformin
IDeg was injected subcutaneously once daily for 26 weeks.
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IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting).
IDeg is injected subcutaneously (under the skin) once daily.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Tidsramme: Week 0, week 26
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Observed mean 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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Change in Body Weight
Tidsramme: Week 0, week 26
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Observed mean 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
- Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
- Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.
- King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.
- Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.
- Ericsson A, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y.
- Buse JB, Vilsboll T, Thurman J, Blevins TC, Langbakke IH, Bottcher SG, Rodbard HW; NN9068-3912 (DUAL-II) Trial Investigators. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014 Nov;37(11):2926-33. doi: 10.2337/dc14-0785. Epub 2014 Aug 11.
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 (Faktiske)
28. november 2011
Primær færdiggørelse (Faktiske)
1. oktober 2012
Studieafslutning (Faktiske)
4. oktober 2012
Datoer for studieregistrering
Først indsendt
7. juli 2011
Først indsendt, der opfyldte QC-kriterier
11. juli 2011
Først opslået (Skøn)
12. juli 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Inkretiner
- Insulin
- Insulin, Globin Zink
- Insulin, langtidsvirkende
- Liraglutid
- Xultophy
Andre undersøgelses-id-numre
- NN9068-3912
- 2011-002336-72 (EudraCT nummer)
- U1111-1121-4897 (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 .