- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00036504
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients New to Insulin Therapy Who Were Inadequately Controlled on Oral Agents
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim of the present study is to compare two treatments - LM twice daily plus metformin two or three times daily versus a long acting insulin comparator once daily plus metformin two or three times daily - in patients with type 2 diabetes who are currently using a regimen of one or more oral antihyperglycemic agents.
The primary objective of this study is to demonstrate that, in patients with type 2 diabetes who are new to insulin, hemoglobin A1c at endpoint will be lower after treatment with insulin lispro LM twice daily plus metformin than after treatment with a long acting insulin comparator once daily plus metformin.
This will be a multicenter, randomized, open-label, crossover study comparing twice-daily insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes who were receiving one or more oral antihyperglycemic agents without insulin prior to the study.
Following an 8 (+-2) week lead-in period consisting of treatment with NPH once daily at bedtime plus metformin two or three times daily, approximately 100 eligible patients will be randomized to one of two sequence groups, so that there are approximately 50 patients in each group. One group will receive 4 months of insulin lispro LM administered immediately before the morning and evening meals plus metformin two or three times daily followed by 4 months of a once-daily long acting insulin comparator at bedtime plus metformin two or three times daily. The other group will receive the reverse sequence.
Studietype
Registrering
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
California
-
LaJolla, California, Forente stater
-
Walnut Creek, California, Forente stater
-
-
Connecticut
-
New Britain, Connecticut, Forente stater
-
-
Florida
-
Longwood, Florida, Forente stater
-
-
Georgia
-
Atlanta, Georgia, Forente stater
-
Fayetteville, Georgia, Forente stater
-
-
Idaho
-
Boise, Idaho, Forente stater
-
-
Illinois
-
Springfield, Illinois, Forente stater
-
-
New Jersey
-
Mt. Laurel, New Jersey, Forente stater
-
New Brunswick, New Jersey, Forente stater
-
-
New York
-
Syracuse, New York, Forente stater
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater
-
-
Texas
-
Dallas, Texas, Forente stater
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes.
- At least 30 years old and less than 80 years old.
- Using oral agents without insulin for 30 days prior ot study.
- Willing to start insulin injections using a pen device.
- Keep a patient diary.
Exclusion Criteria:
- Undergoing therapy for cancers.
- History of renal transplant or receiving renal dialysis.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
- Women who are breastfeeding.
- Have been treated with a drug within the last 30 days that has not received regulatory approval.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Malone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH; Lispro Mixture-Glargine Study Group. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther. 2004 Dec;26(12):2034-44. doi: 10.1016/j.clinthera.2004.12.015. Erratum In: Clin Ther. 2005 Jul;27(7):1112.
- Hirsch IB, Yuan H, Campaigne BN, Tan MH. Impact of prandial plus basal vs basal insulin on glycemic variability in type 2 diabetic patients. Endocr Pract. 2009 May-Jun;15(4):343-8. doi: 10.4158/EP08308.ORR.
- Chan JY, Leyk M, Frier BM, Tan MH. Relationship between HbA1c and hypoglycaemia in patients with type 2 diabetes treated with different insulin regimens in combination with metformin. Diabetes Metab Res Rev. 2009 Mar;25(3):224-31. doi: 10.1002/dmrr.929.
- Shrom D, Sarwat S, Ilag L, Bloomgarden ZT. Does A1c consistently reflect mean plasma glucose? J Diabetes. 2010 Jun;2(2):92-6. doi: 10.1111/j.1753-0407.2010.00066.x. Epub 2010 Jan 22.
- Sarwat S, Ilag LL, Carey MA, Shrom DS, Heine RJ. The relationship between self-monitored blood glucose values and glycated haemoglobin in insulin-treated patients with Type 2 diabetes. Diabet Med. 2010 May;27(5):589-92. doi: 10.1111/j.1464-5491.2010.02955.x.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4050
- F3Z-MC-IOND
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Type 2 diabetes mellitus
-
US Department of Veterans AffairsAmerican Diabetes AssociationFullførtType 2 diabetes mellitusForente stater
-
Dexa Medica GroupFullførtType-2 diabetes mellitusIndonesia
-
University Hospital Inselspital, BerneFullført
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Fullført
-
AstraZenecaRekruttering
-
Daewoong Pharmaceutical Co. LTD.Har ikke rekruttert ennåT2DM (type 2 diabetes mellitus)
-
Zhongda HospitalRekrutteringType 2 diabetes mellitus (T2DM)Kina
-
Newsoara Biopharma Co., Ltd.RekrutteringT2DM (type 2 diabetes mellitus)Kina
-
Shanghai Golden Leaf MedTec Co. LtdAktiv, ikke rekrutterendeType 2 diabetes mellitus (T2DM)Kina
-
SanofiFullført
Kliniske studier på Insulin Lispro low mixture
-
Eli Lilly and CompanyFullførtDiabetes mellitus, type 2Tyrkia, Argentina, Korea, Republikken, Brasil, Kina, Egypt, India, Spania
-
Eli Lilly and CompanyFullførtDiabetes mellitus, type 2Forente stater, Canada, India, Puerto Rico, Australia, Spania, Nederland, Ungarn, Brasil, Hellas, Romania, Argentina
-
Diasome PharmaceuticalsIntegriumFullførtType 1 diabetes mellitusForente stater
-
AdociaEli Lilly and CompanyFullførtFriske deltakereSingapore
-
Inreda Diabetic B.V.Fullført
-
SanofiFullført
-
Eli Lilly and CompanyFullførtType 2 diabetes mellitusJapan, Korea, Republikken, Kina, Tyrkia
-
AdociaEli Lilly and CompanyFullført
-
Chongqing Medical UniversityFullført
-
Universidad de GuanajuatoFullført