Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
4 novembre 2009 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
442
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, C1188AAF
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Ramos Mejia, Argentina, B1704ETD
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Goyang-Si, Corea, Repubblica di, 410-719
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Sungnam-Si, Corea, Repubblica di, 463-712
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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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Chihuahua, Messico, 31238
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Guadalajara, Messico, 44340
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Krakow, Polonia, 30-349
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Poznan, Polonia, 61-495
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Rzeszow, Polonia, 35-068
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Lugo, Spagna, 27004
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Palma de Mallorca, Spagna, 07014
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Santa Cruz de Tenerife, Spagna, 38320
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Valencia, Spagna, 46015
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Alabama
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Hueytown, Alabama, Stati Uniti, 35023
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Arizona
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Litchfield Park, Arizona, Stati Uniti, 85340
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Phoenix, Arizona, Stati Uniti, 85016
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California
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Buena Park, California, Stati Uniti, 90620
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Fountain Valley, California, Stati Uniti, 92708
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Los Angeles, California, Stati Uniti, 90057
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Florida
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Jacksonville, Florida, Stati Uniti, 32257
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Georgia
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Atlanta, Georgia, Stati Uniti, 30312
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Illinois
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Chicago, Illinois, Stati Uniti, 60612
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Indiana
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Evansville, Indiana, Stati Uniti, 47714
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Indianapolis, Indiana, Stati Uniti, 46202
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Newburgh, Indiana, Stati Uniti, 47630
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
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Louisiana
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Slidell, Louisiana, Stati Uniti, 70458
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Maryland
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Prince Frederick, Maryland, Stati Uniti, 20678
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Michigan
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Novi, Michigan, Stati Uniti, 48374
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89101
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New York
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Syracuse, New York, Stati Uniti, 13210
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North Carolina
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Goldsboro, North Carolina, Stati Uniti, 27530
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45236
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London, Ohio, Stati Uniti, 43140
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Oregon
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Bend, Oregon, Stati Uniti, 97701
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Pennsylvania
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Lansdale, Pennsylvania, Stati Uniti, 19446
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South Carolina
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Taylors, South Carolina, Stati Uniti, 29687
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Tennessee
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Johnson City, Tennessee, Stati Uniti, 37604
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Texas
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Grand Prairie, Texas, Stati Uniti, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, Stati Uniti, 53051
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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, Ungheria, H-1139
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Eger, Ungheria, 3300
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Mako, Ungheria, 6900
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Szekesfehervar, Ungheria, 8000
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Szekszard, Ungheria, 7100
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Veszprem, Ungheria, 8200
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Lasso di tempo: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Results are for the combined titration and maintenance periods.
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Baseline to 24 Weeks
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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Lasso di tempo: 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.
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
Lasso di tempo: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Total Daily Insulin Dose (Units) at Endpoint
Lasso di tempo: 24 Weeks
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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
Lasso di tempo: 24 Weeks
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Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
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24 Weeks
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Number of Injections of Basal Insulin Analog at Endpoint
Lasso di tempo: 24 Weeks
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24 Weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2007
Completamento primario (Effettivo)
1 settembre 2008
Completamento dello studio (Effettivo)
1 settembre 2008
Date di iscrizione allo studio
Primo inviato
27 giugno 2007
Primo inviato che soddisfa i criteri di controllo qualità
27 giugno 2007
Primo Inserito (Stima)
29 giugno 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
11 novembre 2009
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 novembre 2009
Ultimo verificato
1 novembre 2009
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10935 (DAIDS-ES)
- F3Z-MC-IOOY
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .