Sammenligning af færdigblandet insulin med insulin Glargine kombineret med hurtigtvirkende insulin hos patienter med type 2-diabetes
26. november 2007 opdateret af: Eli Lilly and Company
En sammenligning af Prandial Insulin Lispro-blandingsterapi med Glargine Basal-Bolus-terapi med Insulin Lispro om den overordnede glykæmiske kontrol af patienter med type 2-diabetes, der tidligere er behandlet med orale midler kombineret med insulin Glargine
Formålet med denne undersøgelse er at sammenligne Lispro Mixture Therapy (insulin lispro 50/50 givet tre gange dagligt i forbindelse med måltider) med Glargine Basal-Bolus Therapy (insulin glargin dagligt med tilsætning af insulin lispro givet tre gange dagligt med måltider).
Undersøgelsen sammenligner også to forskellige metoder til justering af insulindosis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding
300
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Anniston, Alabama, Forenede Stater
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Birmingham, Alabama, Forenede Stater
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Arizona
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Phoenix, Arizona, Forenede Stater
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California
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Concord, California, Forenede Stater
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Inglewood, California, Forenede Stater
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LaJolla, California, Forenede Stater
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Orange, California, Forenede Stater
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West Hills, California, Forenede Stater
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Colorado
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Colorado Springs, Colorado, Forenede Stater
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Florida
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Aventura, Florida, Forenede Stater
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Hollywood, Florida, Forenede Stater
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Maitland, Florida, Forenede Stater
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Melbourne, Florida, Forenede Stater
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West Palm Beach, Florida, Forenede Stater
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Kansas
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Topeka, Kansas, Forenede Stater
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Wichita, Kansas, Forenede Stater
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Kentucky
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Lexington, Kentucky, Forenede Stater
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Louisiana
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Metairie, Louisiana, Forenede Stater
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Massachusetts
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Springfield, Massachusetts, Forenede Stater
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Michigan
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Bloomfield Hills, Michigan, Forenede Stater
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Missouri
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Jefferson City, Missouri, Forenede Stater
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Montana
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Butte, Montana, Forenede Stater
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Nebraska
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Omaha, Nebraska, Forenede Stater
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Nevada
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Reno, Nevada, Forenede Stater
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New Jersey
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New Brunswick, New Jersey, Forenede Stater
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New York
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Mineola, New York, Forenede Stater
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Syracuse, New York, Forenede Stater
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North Carolina
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Raleigh, North Carolina, Forenede Stater
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater
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Oregon
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Corvallis, Oregon, Forenede Stater
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Portland, Oregon, Forenede Stater
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Pennsylvania
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Beaver, Pennsylvania, Forenede Stater
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South Carolina
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Greenville, South Carolina, Forenede Stater
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Tennessee
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Memphis, Tennessee, Forenede Stater
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Texas
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Beaumont, Texas, Forenede Stater
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Dallas, Texas, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Houston, Texas, Forenede Stater
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Irving, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Utah
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Ogden, Utah, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Salt Lake City, Utah, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Washington
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Federal Way, Washington, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Renton, Washington, Forenede Stater
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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West Virginia
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Charleston, West Virginia, Forenede Stater
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Manati, Puerto Rico
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Ponce, Puerto Rico
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San Juan, Puerto Rico
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Toa Baja, Puerto Rico
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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
30 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Skal have type 2 diabetes.
- Skal være 30-75 år på tidspunktet for besøg 1.
- Skal være på insulin glargin og oral antidiabetisk medicin i mindst 90 dage.
- Skal være på mindst 30 enheder glargin om dagen ved tilmelding.
- Har en A1C mellem 7,5 % og 12,0 % ved besøg 1.
Ekskluderingskriterier:
- Må ikke have brugt hurtigt/korttidsvirkende insulin regelmæssigt inden for de sidste 6 måneder.
- Må ikke have mere end én episode af alvorlig hypoglykæmi inden for de sidste 6 måneder.
- Må ikke have et body mass index (BMI) på mere end 45 (morbid fedme).
- Må ikke have kongestiv hjertesvigt, der kræver medicin.
- Må ikke have fået en nyretransplantation eller i øjeblikket i dialyse
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: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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For at teste hypotesen om, at Lispro Mixtures Therapy-regimen i kombination med orale antihyperglykæmiske midler (OADs) er ikke-inferiør
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i overordnet glykæmisk kontrol (lavere A1CF) ved endpoint sammenlignet med Glargine Basal-Bolus-terapi i kombination
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med OADs hos patienter med type 2-diabetes, som tydeligvis ikke har opnået det glykæmiske mål
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(A1C mindre end 7%) med insulin glargin én gang dagligt i kombination med OAD'er.
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Sekundære resultatmål
Resultatmål |
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For at teste følgende i begge arme: frekvens og forekomst
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af selvrapporteret hypoglykæmi, blodsukkerdata, 8-punktsprofiler, insulindosis,
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kropsvægt, SAE'er og lægemiddelrelaterede bivirkninger.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
- Shi LX, Li PF, Hou JN. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens. Diabetes Ther. 2017 Aug;8(4):915-928. doi: 10.1007/s13300-017-0286-z. Epub 2017 Jun 30.
- Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. doi: 10.2337/dc07-1122. Epub 2007 Oct 12.
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. april 2004
Studieafslutning (Faktiske)
1. april 2006
Datoer for studieregistrering
Først indsendt
6. maj 2005
Først indsendt, der opfyldte QC-kriterier
6. maj 2005
Først opslået (Skøn)
9. maj 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. november 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. november 2007
Sidst verificeret
1. november 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9057
- F3Z-US-IOOQ
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 .