- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00928889
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors (ENERGY)
7 maj 2012 uppdaterad av: Novartis Pharmaceuticals
A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
160
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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BeiJing, Kina, 100020
- People's Liberation Army. The Military General Hospital of BeiJing
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BeiJing, Kina, 100034
- Peiking University First Hospital
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Beijing, Kina, 100853
- Chinese PLA General Hospital
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Guangzhou, Kina, 510080
- The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
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Guangzhou, Kina, 510120
- The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
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Guangzhou, Kina, 510515
- Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Newly diagnosed type 2 diabetes mellitus patients
- HbA1c > 6.5 and < 9.0%
- Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control
Exclusion Criteria:
- History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
- Liver disease
- Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks
Other protocol-defined inclusion/exclusion criteria applied to the study.
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)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
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Nateglinide 120 mg was supplied as tablets.
Andra namn:
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Aktiv komparator: Acarbose 50 mg
Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
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Acarbose 50 mg was supplied as tablets.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test.
Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
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Baseline to the end of the study (Week 4)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points.
Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Total cholesterol was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Triglycerides at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Triglycerides were assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
LDL-C was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
HDL-C was assessed at each study site using the same method and same reference value.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
FFA was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
Tidsram: Baseline to the end of the study (Week 4)
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Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
GSA was assayed at a central laboratory.
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Baseline to the end of the study (Week 4)
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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 juli 2009
Primärt slutförande (Faktisk)
1 juni 2010
Avslutad studie (Faktisk)
1 juni 2010
Studieregistreringsdatum
Först inskickad
25 juni 2009
Först inskickad som uppfyllde QC-kriterierna
25 juni 2009
Första postat (Uppskatta)
26 juni 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 maj 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 maj 2012
Senast verifierad
1 maj 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDJN608ACN06
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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