Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
4. november 2009 oppdatert av: Eli Lilly and Company
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
442
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, C1188AAF
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Ramos Mejia, Argentina, B1704ETD
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Alabama
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Hueytown, Alabama, Forente stater, 35023
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Arizona
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Litchfield Park, Arizona, Forente stater, 85340
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Phoenix, Arizona, Forente stater, 85016
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California
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Buena Park, California, Forente stater, 90620
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Fountain Valley, California, Forente stater, 92708
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Los Angeles, California, Forente stater, 90057
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Florida
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Jacksonville, Florida, Forente stater, 32257
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Georgia
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Atlanta, Georgia, Forente stater, 30312
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Illinois
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Chicago, Illinois, Forente stater, 60612
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Indiana
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Evansville, Indiana, Forente stater, 47714
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Indianapolis, Indiana, Forente stater, 46202
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Newburgh, Indiana, Forente stater, 47630
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
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Louisiana
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Slidell, Louisiana, Forente stater, 70458
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Maryland
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Prince Frederick, Maryland, Forente stater, 20678
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Michigan
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Novi, Michigan, Forente stater, 48374
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Nevada
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Las Vegas, Nevada, Forente stater, 89101
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New York
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Syracuse, New York, Forente stater, 13210
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North Carolina
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Goldsboro, North Carolina, Forente stater, 27530
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Ohio
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Cincinnati, Ohio, Forente stater, 45236
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London, Ohio, Forente stater, 43140
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Oregon
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Bend, Oregon, Forente stater, 97701
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Pennsylvania
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Lansdale, Pennsylvania, Forente stater, 19446
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South Carolina
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Taylors, South Carolina, Forente stater, 29687
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Tennessee
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Johnson City, Tennessee, Forente stater, 37604
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Texas
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Grand Prairie, Texas, Forente stater, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, Forente stater, 53051
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Bangalore, India, 560052
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Chennai, India, 600086
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Cochin, India, 682026
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Mumbai, India, 400 067
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Pune, India, 411011
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Goyang-Si, Korea, Republikken, 410-719
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Sungnam-Si, Korea, Republikken, 463-712
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Chihuahua, Mexico, 31238
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Guadalajara, Mexico, 44340
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Krakow, Polen, 30-349
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Poznan, Polen, 61-495
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Rzeszow, Polen, 35-068
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Lugo, Spania, 27004
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Palma de Mallorca, Spania, 07014
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Santa Cruz de Tenerife, Spania, 38320
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Valencia, Spania, 46015
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Chiayi City, Taiwan, 600
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Neihu Taipei, Taiwan, 114
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Tainan, Taiwan, 704
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Taipei, Taiwan, 100
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Yung-Kang, Tainan, Taiwan, 710
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Budapest, Ungarn, H-1139
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Eger, Ungarn, 3300
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Mako, Ungarn, 6900
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Szekesfehervar, Ungarn, 8000
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Szekszard, Ungarn, 7100
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Veszprem, Ungarn, 8200
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have type 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Exclusion Criteria
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Andre navn:
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Aktiv komparator: Detemir
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Tidsramme: Baseline to 24 Weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
|
Baseline to 24 Weeks
|
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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Tidsramme: Baseline, 12 Weeks, 24 Weeks
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Baseline, 12 Weeks, 24 Weeks
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Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
Tidsramme: 24 Weeks
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Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
|
24 Weeks
|
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Glycemic Variability
Tidsramme: 24 Weeks
|
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.
|
24 Weeks
|
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7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Tidsramme: 24 Weeks
|
Actual daily mean blood glucose levels at endpoint.
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24 Weeks
|
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Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Tidsramme: Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Results are for the combined titration and maintenance periods.
|
Baseline to 24 Weeks
|
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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Tidsramme: Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
|
Baseline to 24 Weeks
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Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Tidsramme: Baseline, 24 Weeks
|
Baseline, 24 Weeks
|
|
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Total Daily Insulin Dose (Units) at Endpoint
Tidsramme: 24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
|
24 Weeks
|
|
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
Tidsramme: 24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
|
24 Weeks
|
|
Number of Injections of Basal Insulin Analog at Endpoint
Tidsramme: 24 Weeks
|
24 Weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2007
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
27. juni 2007
Først innsendt som oppfylte QC-kriteriene
27. juni 2007
Først lagt ut (Anslag)
29. juni 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. november 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. november 2009
Sist bekreftet
1. november 2009
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10935 (DAIDS-ES)
- F3Z-MC-IOOY
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