Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
4. november 2009 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
442
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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Buenos Aires, Argentina, C1188AAF
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Ramos Mejia, Argentina, B1704ETD
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Alabama
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Hueytown, Alabama, Forenede Stater, 35023
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Arizona
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Litchfield Park, Arizona, Forenede Stater, 85340
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Phoenix, Arizona, Forenede Stater, 85016
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California
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Buena Park, California, Forenede Stater, 90620
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Fountain Valley, California, Forenede Stater, 92708
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Los Angeles, California, Forenede Stater, 90057
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Florida
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Jacksonville, Florida, Forenede Stater, 32257
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Georgia
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Atlanta, Georgia, Forenede Stater, 30312
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
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Indianapolis, Indiana, Forenede Stater, 46202
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Newburgh, Indiana, Forenede Stater, 47630
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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Louisiana
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Slidell, Louisiana, Forenede Stater, 70458
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Maryland
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Prince Frederick, Maryland, Forenede Stater, 20678
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Michigan
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Novi, Michigan, Forenede Stater, 48374
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89101
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New York
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Syracuse, New York, Forenede Stater, 13210
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North Carolina
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Goldsboro, North Carolina, Forenede Stater, 27530
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45236
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London, Ohio, Forenede Stater, 43140
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Oregon
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Bend, Oregon, Forenede Stater, 97701
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Pennsylvania
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Lansdale, Pennsylvania, Forenede Stater, 19446
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South Carolina
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Taylors, South Carolina, Forenede Stater, 29687
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Tennessee
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Johnson City, Tennessee, Forenede Stater, 37604
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Texas
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Grand Prairie, Texas, Forenede Stater, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, Forenede Stater, 53051
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Bangalore, Indien, 560052
- 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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Chennai, Indien, 600086
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Cochin, Indien, 682026
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Mumbai, Indien, 400 067
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Pune, Indien, 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, Spanien, 27004
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Palma de Mallorca, Spanien, 07014
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Santa Cruz de Tenerife, Spanien, 38320
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Valencia, Spanien, 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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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:
- 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
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 navne:
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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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Hvad måler undersøgelsen?
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 |
Foranstaltningsbeskrivelse |
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.
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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.
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24 Weeks
|
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Glycemic Variability
Tidsramme: 24 Weeks
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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.
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24 Weeks
|
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7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Tidsramme: 24 Weeks
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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.
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Baseline to 24 Weeks
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Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Tidsramme: Baseline, 24 Weeks
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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).
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24 Weeks
|
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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
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24 Weeks
|
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
- 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.
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. august 2007
Primær færdiggørelse (Faktiske)
1. september 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
27. juni 2007
Først indsendt, der opfyldte QC-kriterier
27. juni 2007
Først opslået (Skøn)
29. juni 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. november 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2009
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10935 (DAIDS-ES)
- F3Z-MC-IOOY
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