- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00377858
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX) (IOOX)
4 grudnia 2009 zaktualizowane przez: Eli Lilly and Company
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
484
Faza
- Faza 4
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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South Australia
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Keswick, South Australia, Australia, 5035
- 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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Victoria
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Fitzroy, Victoria, Australia, 3065
- 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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Western Australia
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Fremantle, Western Australia, Australia, 6160
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Arkhangelsk, Federacja Rosyjska, 163045
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Moscow, Federacja Rosyjska, 117036
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Saint Petersburg, Federacja Rosyjska, 193257
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Mantes La Jolie, Francja, 78200
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Menton, Francja, 06500
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Pau, Francja, 64000
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Poitiers, Francja, 86000
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Toulouse, Francja, 31082
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Alicante, Hiszpania, 03114
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Almeria, Hiszpania, 04001
- 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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Barcelona, Hiszpania, 08017
- 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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Bilbao, Hiszpania, 48013
- 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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Malaga, Hiszpania, 29010
- 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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Ontario
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London, Ontario, Kanada, N6A 4L2
- 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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Quebec
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Granby, Quebec, Kanada, J2G 1T7
- 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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Sherbrooke, Quebec, Kanada, J1G 5K2
- 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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Saskatchewan
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Regina, Saskatchewan, Kanada, S4P 0W5
- 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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Chihuahua, Meksyk, 31238
- 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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Guadalajara, Meksyk, 44620
- 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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Goyang-Si/Kyunggi-Do, Republika Korei, 410-719
- 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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Kwang Ju, Republika Korei, 501-757
- 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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Seoul, Republika Korei, 110-746
- 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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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
30 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Have type 2 diabetes
- Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
- Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Exclusion Criteria:
- Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
- Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
- Have a body mass index greater than 40 kg/m2.
- Have had more than one episode of severe hypoglycemia in the last24 weeks
- Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
- Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
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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Eksperymentalny: Insulin Lispro Mid Mixture
Insulin lispro mid mixture (MM) up to three times a day (TID)
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Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
Inne nazwy:
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Aktywny komparator: Insulin Glargine
Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
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Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Ramy czasowe: 36 weeks
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Level of hemoglobin A1c at endpoint.
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36 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Hemoglobin A1c (HbA1c) at Interval Visits
Ramy czasowe: 12, 24, and 36 weeks
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Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
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12, 24, and 36 weeks
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Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Ramy czasowe: 12-24-36 weeks
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12-24-36 weeks
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7-point Self-monitored Blood Glucose Profiles
Ramy czasowe: Baseline, 12-24-36 weeks
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Actual daily mean blood glucose levels at specified time points.
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Baseline, 12-24-36 weeks
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Glycemic Variability
Ramy czasowe: Baseline, 12-24-36 weeks
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Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
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Baseline, 12-24-36 weeks
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Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Ramy czasowe: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Ramy czasowe: Baseline to 36 Weeks
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Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines.
Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking.
Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime.
Overall episodes: those that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Number of Patients With at Least One Severe Hypoglycemia Episode
Ramy czasowe: Baseline to 36 Weeks
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Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident.
The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits.
Endpoint: last visit interval based on LOCF.
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Baseline to 36 Weeks
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Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Ramy czasowe: 36 Weeks
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Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Endpoint Insulin Dose; Total, Basal, and Prandial
Ramy czasowe: 36 Weeks
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Total daily insulin dose (Units of insulin per day [U/day]) was assessed.
Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations.
Prandial insulin is taken at meal time.
Insulin glargine is a basal insulin and insulin lispro is a prandial insulin.
Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro.
Endpoint: last visit interval based on LOCF.
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36 Weeks
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Number of Insulin Injections Per Day
Ramy czasowe: Weeks 12, 24, 30, 36
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Weeks 12, 24, 30, 36
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Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Ramy czasowe: Baseline, 36 Weeks
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Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
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Baseline, 36 Weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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 sierpnia 2006
Zakończenie podstawowe (Rzeczywisty)
1 września 2008
Ukończenie studiów (Rzeczywisty)
1 września 2008
Daty rejestracji na studia
Pierwszy przesłany
11 września 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 września 2006
Pierwszy wysłany (Oszacować)
19 września 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
9 grudnia 2009
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
4 grudnia 2009
Ostatnia weryfikacja
1 grudnia 2009
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 10936 (Identyfikator rejestru: DAIDS ES)
- F3Z-MC-IOOX
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 .
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Leiden University Medical CenterZakończonyGruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; NiedobórHolandia
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Centre Hospitalier Universitaire de LiegeSanofi; Takeda; University of Liege; Orchard Therapeutics; Centre Hospitalier Régional... i inni współpracownicyRekrutacyjnyWrodzony przerost nadnerczy | Hemofilia A | Hemofilia B | Mukopolisacharydoza I | Mukopolisacharydoza II | Mukowiscydoza | Niedobór alfa 1-antytrypsyny | Anemia sierpowata | Anemia Fanconiego | Przewlekła choroba ziarniniakowa | Choroba Wilsona | Ciężka wrodzona neutropenia | Niedobór transkarbamylazy ornityny | Mukopolisacharydoza... i inne warunkiBelgia
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UK Kidney AssociationRekrutacyjnyZapalenie naczyń | AL Amyloidoza | Stwardnienie guzowate | Choroba Fabry'ego | Cystynuria | Ogniskowe segmentowe stwardnienie kłębuszków nerkowych | Nefropatia IgA | Syndrom Barttera | Czysta aplazja czerwonokrwinkowa | Nefropatia błoniasta | Atypowy zespół hemolityczno-mocznicowy | Autosomalna dominująca policystyczna... i inne warunkiZjednoczone Królestwo
Badania kliniczne na Insulin lispro mid mixture (MM)
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Diasome PharmaceuticalsZakończonyCukrzyca typu 1Stany Zjednoczone
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Eli Lilly and CompanyZakończonyCukrzyca typu 2Kanada, Indie, Rumunia, Hiszpania, Meksyk, Indyk, Portugalia, Egipt