Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

15. maj 2014 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

133

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater
        • 1218.43.10027 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, Forenede Stater
        • 1218.43.10011 Boehringer Ingelheim Investigational Site
      • Riverside, California, Forenede Stater
        • 1218.43.10006 Boehringer Ingelheim Investigational Site
      • Whittier, California, Forenede Stater
        • 1218.43.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Pembroke Pines, Florida, Forenede Stater
        • 1218.43.10013 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, Forenede Stater
        • 1218.43.10009 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, Forenede Stater
        • 1218.43.10018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • 1218.43.10022 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater
        • 1218.43.10015 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, Forenede Stater
        • 1218.43.10016 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, Forenede Stater
        • 1218.43.10004 Boehringer Ingelheim Investigational Site
      • Great Neck, New York, Forenede Stater
        • 1218.43.10003 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater
        • 1218.43.10020 Boehringer Ingelheim Investigational Site
    • Ohio
      • Delaware, Ohio, Forenede Stater
        • 1218.43.10019 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, Forenede Stater
        • 1218.43.10008 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater
        • 1218.43.10005 Boehringer Ingelheim Investigational Site
      • Carlisle, Pennsylvania, Forenede Stater
        • 1218.43.10007 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater
        • 1218.43.10001 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Aiken, South Carolina, Forenede Stater
        • 1218.43.10025 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater
        • 1218.43.10023 Boehringer Ingelheim Investigational Site
      • Austin, Texas, Forenede Stater
        • 1218.43.10024 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, Forenede Stater
        • 1218.43.10014 Boehringer Ingelheim Investigational Site
      • Lufkin, Texas, Forenede Stater
        • 1218.43.10017 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, Forenede Stater
        • 1218.43.10010 Boehringer Ingelheim Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • 1218.43.85201 Boehringer Ingelheim Investigational Site
      • New Territories, Hong Kong
        • 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
  • New Zealand
      • Auckland, New Zealand
        • 1218.43.64001 Boehringer Ingelheim Investigational Site
      • Christchurch, New Zealand
        • 1218.43.64003 Boehringer Ingelheim Investigational Site
      • Takpuna, New Zealand
        • 1218.43.64004 Boehringer Ingelheim Investigational Site
      • Tauranga, New Zealand
        • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BI 1356
patient to receive a tablet containing BI 1356 once daily
Medicin: BI 1356
BI 1356 dosed once daily
Placebo komparator: placebo
patient to receive a tablet identical to BI 1356 once daily
Medicin: placebo
placebo matching BI 1356 taken once daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c Change From Baseline at Week 12
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c Change From Baseline at Week 52
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 ....

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

1. december 2008

Først indsendt, der opfyldte QC-kriterier

1. december 2008

Først opslået (Skøn)

2. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner