- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00318656
24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
10 april 2009 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
23
Fas
- Fas 4
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2005
Primärt slutförande (Faktisk)
1 oktober 2007
Avslutad studie (Faktisk)
1 oktober 2007
Studieregistreringsdatum
Först inskickad
25 april 2006
Först inskickad som uppfyllde QC-kriterierna
25 april 2006
Första postat (Uppskatta)
27 april 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 maj 2009
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 april 2009
Senast verifierad
1 april 2009
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 104988
- AVAF4003
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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