A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
11. května 2011 aktualizováno: 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).
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
374
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Genk, Belgie, 3600
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Leuven, Belgie, 3000
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Willebroek, Belgie, 2830
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Ancona, Itálie, 60131
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Bari, Itálie, 70124
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Milano, Itálie, 20162
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Padova, Itálie, 35143
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Pistoia, Itálie, 51100
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Ravenna, Itálie, 48100
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Rome, Itálie, 00189
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Bornova, Krocan, 35100
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Istanbul, Krocan, 34662
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Izmir, Krocan, 35360
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Bad Mergentheim, Německo, D-97980
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Berlin, Německo, D-12351
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Damme, Německo, D-49401
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Dresden, Německo, D-01219
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Hamburg, Německo, D-22177
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Hannover, Německo, 30519
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Pirna, Německo, 01796
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Rotenburg-Fulda, Německo, D-36199
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Gorzow Wielkopolski, Polsko, 66-400
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Krakow, Polsko, 31-159
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Lodz, Polsko, 93-338
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Lubin, Polsko, 59-301
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Mielec, Polsko, 39-300
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Poznan, Polsko, 61-696
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Warsaw, Polsko, 02-577
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Wroclaw, Polsko, 503-349
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Baia Mare, Rumunsko, 430071
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Bucharest, Rumunsko, 020475
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Cluj-Napoca, Rumunsko, 400006
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Sf Gheorghe, Rumunsko
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Banska Bystrica, Slovensko, 97405
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Bratislava, Slovensko, 821 06
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Modra, Slovensko, 900 01
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Nitra, Slovensko, 94901
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Scotland
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Edinburgh, Scotland, Spojené království, EH3 9YW
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South Yorkshire
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Sheffield, South Yorkshire, Spojené království, S5 7AU
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Warwickshire
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Rugby, Warwickshire, Spojené království, CV22 5PX
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West Midlands
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West Bromwich, West Midlands, Spojené království, B71 4HJ
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Holesov, Česká republika, 769 01
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Hranice I-Mesto, Česká republika, 753 01
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Olomouc, Česká republika, 77200
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Ostrava, Česká republika, 709 00
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Plzen, Česká republika, 301 66
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Prague, Česká republika, 149 00
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Athens, Řecko, 11526
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Larissa, Řecko, 41221
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Thessaloniki, Řecko, 56429
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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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Experimentální: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in HbA1c at Week 12 and Week 24
Časové okno: 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
Časové okno: Week 24
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Week 24
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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 24
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Week 24
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2008
Primární dokončení (Aktuální)
1. února 2010
Dokončení studie (Aktuální)
1. února 2010
Termíny zápisu do studia
První předloženo
23. dubna 2008
První předloženo, které splnilo kritéria kontroly kvality
23. dubna 2008
První zveřejněno (Odhad)
25. dubna 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
13. května 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. května 2011
Naposledy ověřeno
1. května 2011
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Poruchy metabolismu glukózy
- Metabolické choroby
- Onemocnění endokrinního systému
- Diabetes Mellitus
- Diabetes mellitus, typ 2
- Hypoglykemická činidla
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Koagulanty
- Antagonisté heparinu
- Inzulín
- Inzulin, Globin Zinek
- Inzulin glargin
- Inzulín Lispro
- Protaminy
Další identifikační čísla studie
- 12047 (Identifikátor registru: DAIDS-ES Registry Number)
- F3Z-EW-IOPJ (Jiný identifikátor: Eli Lilly and Company)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .