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Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

23. Mai 2013 aktualisiert von: Takeda

Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes

The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.

This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

71

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria

  • Diagnosis of type 2 diabetes
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
  • Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
  • Fasting plasma glucose less than 13.3 mmol per L.
  • Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
  • Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
  • Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
  • If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
  • Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

  • History of type 1 diabetes.
  • History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
  • Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
  • History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
  • Hemoglobin less than 120 g per L for males and less than100 g per L for females.
  • Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Serum creatinine level greater than 133 μmol per L.
  • Fasting total cholesterol greater than 6.5 mmol per L.
  • New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
  • History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
  • History of acute metabolic diabetic complications.
  • History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
  • History of infection with human immunodeficiency virus.
  • History of diabetic gastro paresis.
  • History of gastric bypass surgery.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo QD
Arzneimittel: Placebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Andere Namen:
  • Actos
  • SYR-322
  • AD-4833
Experimental: Alogliptin 25 mg einmal täglich
Arzneimittel: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Andere Namen:
  • SYR-322
  • SYR110322
Experimental: Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Arzneimittel: Alogliptin and Pioglitazone
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Andere Namen:
  • Actos
  • SYR-322
  • SYR110322
  • AD-4833
  • Alogliptin

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
Zeitfenster: Baseline and Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Baseline and Week 16.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
Zeitfenster: Baseline and Week 4.
The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
Zeitfenster: Baseline, Week 4 and Week 16.
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Zeitfenster: Baseline, Week 4 and Week 16.
Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Zeitfenster: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
Zeitfenster: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Insulin
Zeitfenster: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon
Zeitfenster: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Glycosylated Hemoglobin
Zeitfenster: Baseline, Week 8 and Week 16.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Baseline, Week 8 and Week 16.
Change From Baseline in Fasting Plasma Glucose
Zeitfenster: Baseline, Week 4, Week 8 and Week 16.
The change in fasting plasma glucose collected at each week indicated relative to baseline.
Baseline, Week 4, Week 8 and Week 16.
Change From Baseline in Postprandial C-Peptide
Zeitfenster: Baseline, Week 4 and Week 16.
The change in postprandial C-peptide collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Proinsulin
Zeitfenster: Baseline, Week 4 and Week 16.
The change in postprandial proinsulin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
Zeitfenster: Baseline, Week 4 and Week 16.
The change in hs-CRP collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Adiponectin
Zeitfenster: Baseline, Week 4 and Week 16.
The change in adiponectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
Zeitfenster: Baseline, Week 4 and Week 16.
The change in VCAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
Zeitfenster: Baseline, Week 4 and Week 16.
The change in ICAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in e-Selectin
Zeitfenster: Baseline, Week 4 and Week 16.
The change in e-Selectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
Zeitfenster: Baseline and Week 16.
Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Baseline and Week 16.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Takeda

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2007

Primärer Abschluss (Tatsächlich)

1. Dezember 2009

Studienabschluss (Tatsächlich)

1. Dezember 2009

Studienanmeldedaten

Zuerst eingereicht

4. April 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. April 2008

Zuerst gepostet (Schätzen)

10. April 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Mai 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Mai 2013

Zuletzt verifiziert

1. Mai 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SYR-322_301
  • 2007-000486-38 (EudraCT-Nummer)
  • U1111-1113-2081 (Registrierungskennung: WHO)
  • NL22649.029.08 (Registrierungskennung: CCMO)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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