A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
11 maja 2011 zaktualizowane przez: 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).
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
374
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Genk, Belgia, 3600
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Leuven, Belgia, 3000
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Willebroek, Belgia, 2830
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Athens, Grecja, 11526
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Larissa, Grecja, 41221
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Thessaloniki, Grecja, 56429
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Bornova, Indyk, 35100
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Istanbul, Indyk, 34662
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Izmir, Indyk, 35360
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Bad Mergentheim, Niemcy, D-97980
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Berlin, Niemcy, D-12351
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Damme, Niemcy, D-49401
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Dresden, Niemcy, D-01219
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Hamburg, Niemcy, D-22177
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Hannover, Niemcy, 30519
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Pirna, Niemcy, 01796
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Rotenburg-Fulda, Niemcy, D-36199
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Gorzow Wielkopolski, Polska, 66-400
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Krakow, Polska, 31-159
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Lodz, Polska, 93-338
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Lubin, Polska, 59-301
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Mielec, Polska, 39-300
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Poznan, Polska, 61-696
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Warsaw, Polska, 02-577
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Wroclaw, Polska, 503-349
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Holesov, Republika Czeska, 769 01
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Hranice I-Mesto, Republika Czeska, 753 01
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Olomouc, Republika Czeska, 77200
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Ostrava, Republika Czeska, 709 00
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Plzen, Republika Czeska, 301 66
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Prague, Republika Czeska, 149 00
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Baia Mare, Rumunia, 430071
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Bucharest, Rumunia, 020475
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Cluj-Napoca, Rumunia, 400006
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Sf Gheorghe, Rumunia
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Banska Bystrica, Słowacja, 97405
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Bratislava, Słowacja, 821 06
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Modra, Słowacja, 900 01
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Nitra, Słowacja, 94901
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Ancona, Włochy, 60131
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Bari, Włochy, 70124
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Milano, Włochy, 20162
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Padova, Włochy, 35143
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Pistoia, Włochy, 51100
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Ravenna, Włochy, 48100
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Rome, Włochy, 00189
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Scotland
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Edinburgh, Scotland, Zjednoczone Królestwo, EH3 9YW
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South Yorkshire
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Sheffield, South Yorkshire, Zjednoczone Królestwo, S5 7AU
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Warwickshire
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Rugby, Warwickshire, Zjednoczone Królestwo, CV22 5PX
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West Midlands
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West Bromwich, West Midlands, Zjednoczone Królestwo, B71 4HJ
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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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Eksperymentalny: 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
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in HbA1c at Week 12 and Week 24
Ramy czasowe: 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
Ramy czasowe: Week 24
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Week 24
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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Week 24
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Week 24
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2008
Zakończenie podstawowe (Rzeczywisty)
1 lutego 2010
Ukończenie studiów (Rzeczywisty)
1 lutego 2010
Daty rejestracji na studia
Pierwszy przesłany
23 kwietnia 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 kwietnia 2008
Pierwszy wysłany (Oszacować)
25 kwietnia 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
13 maja 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 maja 2011
Ostatnia weryfikacja
1 maja 2011
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Zaburzenia metabolizmu glukozy
- Choroby metaboliczne
- Choroby układu hormonalnego
- Cukrzyca
- Cukrzyca typu 2
- Środki hipoglikemizujące
- Fizjologiczne skutki leków
- Molekularne mechanizmy działania farmakologicznego
- Koagulanty
- Antagoniści heparyny
- Insulina
- Insulina, Globin Cynk
- Insulina glargine
- Insulina Lispro
- Protaminy
Inne numery identyfikacyjne badania
- 12047 (Identyfikator rejestru: DAIDS-ES Registry Number)
- F3Z-EW-IOPJ (Inny identyfikator: Eli Lilly and Company)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .