A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
11 maggio 2011 aggiornato da: Eli Lilly and Company
A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
374
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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Genk, Belgio, 3600
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Leuven, Belgio, 3000
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Willebroek, Belgio, 2830
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Bad Mergentheim, Germania, D-97980
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Berlin, Germania, D-12351
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Damme, Germania, D-49401
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Dresden, Germania, D-01219
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Hamburg, Germania, D-22177
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Hannover, Germania, 30519
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Pirna, Germania, 01796
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Rotenburg-Fulda, Germania, D-36199
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Athens, Grecia, 11526
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Larissa, Grecia, 41221
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Thessaloniki, Grecia, 56429
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Ancona, Italia, 60131
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Bari, Italia, 70124
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Milano, Italia, 20162
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Padova, Italia, 35143
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Pistoia, Italia, 51100
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Ravenna, Italia, 48100
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Rome, Italia, 00189
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Gorzow Wielkopolski, Polonia, 66-400
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Krakow, Polonia, 31-159
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Lodz, Polonia, 93-338
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Lubin, Polonia, 59-301
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Mielec, Polonia, 39-300
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Poznan, Polonia, 61-696
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Warsaw, Polonia, 02-577
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Wroclaw, Polonia, 503-349
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Scotland
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Edinburgh, Scotland, Regno Unito, EH3 9YW
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South Yorkshire
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Sheffield, South Yorkshire, Regno Unito, S5 7AU
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Warwickshire
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Rugby, Warwickshire, Regno Unito, CV22 5PX
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West Midlands
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West Bromwich, West Midlands, Regno Unito, B71 4HJ
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Holesov, Repubblica Ceca, 769 01
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Hranice I-Mesto, Repubblica Ceca, 753 01
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Olomouc, Repubblica Ceca, 77200
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Ostrava, Repubblica Ceca, 709 00
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Plzen, Repubblica Ceca, 301 66
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Prague, Repubblica Ceca, 149 00
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Baia Mare, Romania, 430071
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Bucharest, Romania, 020475
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Cluj-Napoca, Romania, 400006
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Sf Gheorghe, Romania
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Banska Bystrica, Slovacchia, 97405
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Bratislava, Slovacchia, 821 06
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Modra, Slovacchia, 900 01
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Nitra, Slovacchia, 94901
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Bornova, Tacchino, 35100
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Istanbul, Tacchino, 34662
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Izmir, Tacchino, 35360
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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:
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- Capable and willing to follow the protocol
- Give written consent
Exclusion Criteria:
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
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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Comparatore attivo: Glargine
Glargine plus Insulin Lispro (2-3 injections)
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patient glucose-level dependent, injection, once daily in the evening, 24 weeks
subcutaneous injections prior to meals, 24 weeks
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Sperimentale: ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
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subcutaneous injections prior to meals, 24 weeks
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
Lasso di tempo: Baseline, Week 24
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Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
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Baseline, Week 24
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in HbA1c at Week 12 and Week 24
Lasso di tempo: Baseline, Week 12, Week 24
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LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
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Baseline, Week 12, Week 24
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Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
Lasso di tempo: Week 24
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Week 24
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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Lasso di tempo: 24 weeks
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours.
Postprandial glucose is measured 2 hours after the start of the meal.
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24 weeks
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Glycemic Variability at Endpoint
Lasso di tempo: Week 24
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LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe).
Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
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Week 24
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Rate Of All Self-reported Hypoglycemic Episodes
Lasso di tempo: Baseline through Week 24
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Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L.
Rate=episodes/30 days/patient/.
Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period.
Nocturnal=Episode between bedtime and waking.
Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
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Baseline through Week 24
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Percentage of Participants With Self-Reported Hypoglycemic Episodes
Lasso di tempo: Baseline through Week 24
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Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment.
Overall=any time post-randomization visits in the study period.
Nocturnal=Episode that occurs between bedtime and waking.
Non-Nocturnal=Episode occurring between waking and bedtime.
Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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Baseline through Week 24
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Number of Participants With Adverse Events (AE)
Lasso di tempo: Baseline through Week 24
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A listing of adverse events is located in the Reported Adverse Event module.
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Baseline through Week 24
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Change in Body Weight From Baseline to Week 24
Lasso di tempo: Baseline, Week 24
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
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Baseline, Week 24
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Total Daily Insulin Dose at Endpoint
Lasso di tempo: Week 24
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
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Week 24
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Number of Injections of Insulin at Week 24
Lasso di tempo: Week 24
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Week 24
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 aprile 2008
Completamento primario (Effettivo)
1 febbraio 2010
Completamento dello studio (Effettivo)
1 febbraio 2010
Date di iscrizione allo studio
Primo inviato
23 aprile 2008
Primo inviato che soddisfa i criteri di controllo qualità
23 aprile 2008
Primo Inserito (Stima)
25 aprile 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
13 maggio 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 maggio 2011
Ultimo verificato
1 maggio 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disturbi del metabolismo del glucosio
- Malattie metaboliche
- Malattie del sistema endocrino
- Diabete mellito
- Diabete mellito, tipo 2
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Coagulanti
- Antagonisti dell'eparina
- Insulina
- Insulina, Globina Zinco
- Insulina Glargina
- Insulina lispro
- Protamine
Altri numeri di identificazione dello studio
- 12047 (Identificatore di registro: DAIDS-ES Registry Number)
- F3Z-EW-IOPJ (Altro identificatore: Eli Lilly and Company)
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 .