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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

15. Mai 2014 aktualisiert von: Boehringer Ingelheim

Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

133

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

  • Australien
      • Adelaide, SA, Australien
        • 1218.43.61005 Boehringer Ingelheim Investigational Site
      • Herston, QLD, Australien
        • 1218.43.61002 Boehringer Ingelheim Investigational Site
    • New South Wales
      • Gosford, New South Wales, Australien
        • 1218.43.61009 Boehringer Ingelheim Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australien
        • 1218.43.61010 Boehringer Ingelheim Investigational Site
      • Kippa Ring, Queensland, Australien
        • 1218.43.61006 Boehringer Ingelheim Investigational Site
    • Victoria
      • Reservoir, Victoria, Australien
        • 1218.43.61007 Boehringer Ingelheim Investigational Site
      • Richmond, Victoria, Australien
        • 1218.43.61011 Boehringer Ingelheim Investigational Site
  • Hongkong
      • Hong Kong, Hongkong
        • 1218.43.85201 Boehringer Ingelheim Investigational Site
      • New Territories, Hongkong
        • 1218.43.85203 Boehringer Ingelheim Investigational Site
  • Israel
      • Afula, Israel
        • 1218.43.97008 Boehringer Ingelheim Investigational Site
      • Ashkelon, Israel
        • 1218.43.97005 Boehringer Ingelheim Investigational Site
      • Haifa, Israel
        • 1218.43.97003 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.43.97004 Boehringer Ingelheim Investigational Site
      • Jerusalem, Israel
        • 1218.43.97009 Boehringer Ingelheim Investigational Site
      • Kfar Saba, Israel
        • 1218.43.97002 Boehringer Ingelheim Investigational Site
      • Nahariya, Israel
        • 1218.43.97007 Boehringer Ingelheim Investigational Site
      • Safed, Israel
        • 1218.43.97001 Boehringer Ingelheim Investigational Site
      • Tel Aviv, Israel
        • 1218.43.97006 Boehringer Ingelheim Investigational Site
  • Neuseeland
      • Auckland, Neuseeland
        • 1218.43.64001 Boehringer Ingelheim Investigational Site
      • Christchurch, Neuseeland
        • 1218.43.64003 Boehringer Ingelheim Investigational Site
      • Takpuna, Neuseeland
        • 1218.43.64004 Boehringer Ingelheim Investigational Site
      • Tauranga, Neuseeland
        • 1218.43.64002 Boehringer Ingelheim Investigational Site
  • Ukraine
      • Kharkiv, Ukraine
        • 1218.43.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1218.43.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, Ukraine
        • 1218.43.38006 Boehringer Ingelheim Investigational Site
      • Kiev, Ukraine
        • 1218.43.38005 Boehringer Ingelheim Investigational Site
      • Lugansk, Ukraine
        • 1218.43.38007 Boehringer Ingelheim Investigational Site
      • Ternopil, Ukraine
        • 1218.43.38008 Boehringer Ingelheim Investigational Site
      • Zaporizhzhya, Ukraine
        • 1218.43.38002 Boehringer Ingelheim Investigational Site
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten
        • 1218.43.10027 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, Vereinigte Staaten
        • 1218.43.10011 Boehringer Ingelheim Investigational Site
      • Riverside, California, Vereinigte Staaten
        • 1218.43.10006 Boehringer Ingelheim Investigational Site
      • Whittier, California, Vereinigte Staaten
        • 1218.43.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Pembroke Pines, Florida, Vereinigte Staaten
        • 1218.43.10013 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, Vereinigte Staaten
        • 1218.43.10009 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, Vereinigte Staaten
        • 1218.43.10018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten
        • 1218.43.10022 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Vereinigte Staaten
        • 1218.43.10015 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten
        • 1218.43.10016 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, Vereinigte Staaten
        • 1218.43.10004 Boehringer Ingelheim Investigational Site
      • Great Neck, New York, Vereinigte Staaten
        • 1218.43.10003 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Vereinigte Staaten
        • 1218.43.10020 Boehringer Ingelheim Investigational Site
    • Ohio
      • Delaware, Ohio, Vereinigte Staaten
        • 1218.43.10019 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, Vereinigte Staaten
        • 1218.43.10008 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Vereinigte Staaten
        • 1218.43.10005 Boehringer Ingelheim Investigational Site
      • Carlisle, Pennsylvania, Vereinigte Staaten
        • 1218.43.10007 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten
        • 1218.43.10001 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Aiken, South Carolina, Vereinigte Staaten
        • 1218.43.10025 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, Vereinigte Staaten
        • 1218.43.10023 Boehringer Ingelheim Investigational Site
      • Austin, Texas, Vereinigte Staaten
        • 1218.43.10024 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Vereinigte Staaten
        • 1218.43.10014 Boehringer Ingelheim Investigational Site
      • Lufkin, Texas, Vereinigte Staaten
        • 1218.43.10017 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, Vereinigte Staaten
        • 1218.43.10010 Boehringer Ingelheim Investigational Site

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 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion criteria:

  • Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
  • Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Unstable or acute congestive heart failure

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: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: BI 1356
patient to receive a tablet containing BI 1356 once daily
Arzneimittel: BI 1356
BI 1356 dosed once daily
Placebo-Komparator: placebo
patient to receive a tablet identical to BI 1356 once daily
Arzneimittel: placebo
placebo matching BI 1356 taken once daily

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HbA1c Change From Baseline at Week 12
Zeitfenster: Baseline and Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HbA1c Change From Baseline at Week 52
Zeitfenster: Baseline and Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 52
HbA1c Change From Baseline at Week 18
Zeitfenster: Baseline and Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 18
HbA1c Change From Baseline at Week 24
Zeitfenster: Baseline and Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 24
HbA1c Change From Baseline at Week 30
Zeitfenster: Baseline and Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 30
HbA1c Change From Baseline at Week 36
Zeitfenster: Baseline and Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 36
HbA1c Change From Baseline at Week 42
Zeitfenster: Baseline and Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 42
HbA1c Change From Baseline at Week 48
Zeitfenster: Baseline and Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 48
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
Zeitfenster: Baseline and Week 52
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Baseline and Week 52
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
Zeitfenster: Baseline and Week 52
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Baseline and Week 52
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
Zeitfenster: Baseline and Week 52
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Baseline and Week 52
FPG Change From Baseline at Week 12
Zeitfenster: Baseline and Week 12
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 12
FPG Change From Baseline at Week 18
Zeitfenster: Baseline and Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 18
FPG Change From Baseline at Week 24
Zeitfenster: Baseline and Week 24
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 24
FPG Change From Baseline at Week 30
Zeitfenster: Baseline and Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 30
FPG Change From Baseline at Week 36
Zeitfenster: Baseline and Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 36
FPG Change From Baseline at Week 42
Zeitfenster: Baseline and Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 42
FPG Change From Baseline at Week 48
Zeitfenster: Baseline and Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 48
FPG Change From Baseline at week52
Zeitfenster: Baseline and Week 52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 52
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
Zeitfenster: Baseline and Week 52
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Baseline and Week 52
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
Zeitfenster: first administration of randomised treatment to ....
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
first administration of randomised treatment to ....

Mitarbeiter und Ermittler

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

Sponsor

Boehringer Ingelheim

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

Nützliche Links

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. Dezember 2008

Primärer Abschluss (Tatsächlich)

1. Januar 2011

Studienanmeldedaten

Zuerst eingereicht

1. Dezember 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Dezember 2008

Zuerst gepostet (Schätzen)

2. Dezember 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Mai 2014

Zuletzt verifiziert

1. Mai 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1218.43
  • 2008-001569-27 (EudraCT-Nummer: EudraCT)

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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