24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
10 kwietnia 2009 zaktualizowane przez: GlaxoSmithKline
Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.
A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients.
The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
23
Faza
- Faza 4
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
40 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Males and females aged 40 to 80 years
- Diagnosis of type 2 diabetes mellitus for at least 6 months
- Body mass index (BMI) ≥25kg/m2
- 7%≥HbA1c ≤ 9% at visit 2
- Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1
- Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures
- Written informed consent
Exclusion Criteria:
- Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
- Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
- Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
- Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
- Subjects with a history of severe hypoglycaemia
- Anemia defined by haemoglobin concentration <11.0g/dL for males or <10.0g/dL for females
- Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females
- Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase >2.5 times the upper limit of the normal reference range)
- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
- Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
- Female who are lactating, pregnant, or planning to become pregnant
- Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...)
- Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study
- Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
- Subjects not willing to comply with the procedures described in this protocol.
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)
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
HbA1c (Glycosylated Hemoglobin)
Ramy czasowe: Baseline and 12 weeks
|
Uncontrolled HbA1c>8.5%.
HbA1c and fasting blood glucose taken at hospital
|
Baseline and 12 weeks
|
|
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
Ramy czasowe: Baseline and 12 weeks
|
8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal.
The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Nocturnal), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Diurnal), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Dawn), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (MAGE), mg/dL
Ramy czasowe: Baseline and 12 weeks
|
Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.
|
Baseline and 12 weeks
|
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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 listopada 2005
Zakończenie podstawowe (Rzeczywisty)
1 października 2007
Ukończenie studiów (Rzeczywisty)
1 października 2007
Daty rejestracji na studia
Pierwszy przesłany
25 kwietnia 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 kwietnia 2006
Pierwszy wysłany (Oszacować)
27 kwietnia 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
7 maja 2009
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 kwietnia 2009
Ostatnia weryfikacja
1 kwietnia 2009
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 104988
- AVAF4003
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 .