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Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors (ENERGY)

7. mai 2012 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
      • BeiJing, Kina, 100020
        • People's Liberation Army. The Military General Hospital of BeiJing
      • BeiJing, Kina, 100034
        • Peiking University First Hospital
      • Beijing, Kina, 100853
        • Chinese PLA General Hospital
      • Guangzhou, Kina, 510080
        • The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
      • Guangzhou, Kina, 510120
        • The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
      • Guangzhou, Kina, 510515
        • Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Nateglinide 120 mg
Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
Legemiddel: Nateglinide 120 mg
Nateglinide 120 mg was supplied as tablets.
Andre navn:
  • Starlix
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.
Legemiddel: Acarbose 50 mg
Acarbose 50 mg was supplied as tablets.
Andre navn:
  • Glucobay

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Triglycerides at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)
Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
Tidsramme: Baseline to the end of the study (Week 4)
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.
Baseline to the end of the study (Week 4)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2009

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

25. juni 2009

Først innsendt som oppfylte QC-kriteriene

25. juni 2009

Først lagt ut (Anslag)

26. juni 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. mai 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2012

Sist bekreftet

1. mai 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDJN608ACN06

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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