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

Last updated: May 15, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Kidney Failure (Pediatric)

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT00800683
1218.43
2008-001569-27
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylureawithin 3 months prior to informed consent

  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months priorto informed consent

  • Unstable or acute congestive heart failure

Study Design

Total Participants: 133
Study Start date:
December 01, 2008
Estimated Completion Date:

Connect with a study center

  • 1218.43.61009 Boehringer Ingelheim Investigational Site

    Gosford, New South Wales
    Australia

    Site Not Available

  • 1218.43.61010 Boehringer Ingelheim Investigational Site

    Auchenflower, Queensland
    Australia

    Site Not Available

  • 1218.43.61006 Boehringer Ingelheim Investigational Site

    Kippa Ring, Queensland
    Australia

    Site Not Available

  • 1218.43.61007 Boehringer Ingelheim Investigational Site

    Reservoir, Victoria
    Australia

    Site Not Available

  • 1218.43.61011 Boehringer Ingelheim Investigational Site

    Richmond, Victoria
    Australia

    Site Not Available

  • 1218.43.61005 Boehringer Ingelheim Investigational Site

    Adelaide, SA,
    Australia

    Site Not Available

  • 1218.43.61002 Boehringer Ingelheim Investigational Site

    Herston, QLD,
    Australia

    Site Not Available

  • 1218.43.85201 Boehringer Ingelheim Investigational Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • 1218.43.85203 Boehringer Ingelheim Investigational Site

    New Territories,
    Hong Kong

    Site Not Available

  • 1218.43.97008 Boehringer Ingelheim Investigational Site

    Afula,
    Israel

    Site Not Available

  • 1218.43.97005 Boehringer Ingelheim Investigational Site

    Ashkelon,
    Israel

    Site Not Available

  • 1218.43.97003 Boehringer Ingelheim Investigational Site

    Haifa,
    Israel

    Site Not Available

  • 1218.43.97004 Boehringer Ingelheim Investigational Site

    Jerusalem,
    Israel

    Site Not Available

  • 1218.43.97009 Boehringer Ingelheim Investigational Site

    Jerusalem,
    Israel

    Site Not Available

  • 1218.43.97002 Boehringer Ingelheim Investigational Site

    Kfar Saba,
    Israel

    Site Not Available

  • 1218.43.97007 Boehringer Ingelheim Investigational Site

    Nahariya,
    Israel

    Site Not Available

  • 1218.43.97001 Boehringer Ingelheim Investigational Site

    Safed,
    Israel

    Site Not Available

  • 1218.43.97006 Boehringer Ingelheim Investigational Site

    Tel Aviv,
    Israel

    Site Not Available

  • 1218.43.64001 Boehringer Ingelheim Investigational Site

    Auckland,
    New Zealand

    Site Not Available

  • 1218.43.64003 Boehringer Ingelheim Investigational Site

    Christchurch,
    New Zealand

    Site Not Available

  • 1218.43.64004 Boehringer Ingelheim Investigational Site

    Takpuna,
    New Zealand

    Site Not Available

  • 1218.43.64002 Boehringer Ingelheim Investigational Site

    Tauranga,
    New Zealand

    Site Not Available

  • 1218.43.38004 Boehringer Ingelheim Investigational Site

    Kharkiv,
    Ukraine

    Site Not Available

  • 1218.43.38003 Boehringer Ingelheim Investigational Site

    Kharkov,
    Ukraine

    Site Not Available

  • 1218.43.38006 Boehringer Ingelheim Investigational Site

    Kharkov,
    Ukraine

    Site Not Available

  • 1218.43.38005 Boehringer Ingelheim Investigational Site

    Kiev,
    Ukraine

    Site Not Available

  • 1218.43.38007 Boehringer Ingelheim Investigational Site

    Lugansk,
    Ukraine

    Site Not Available

  • 1218.43.38008 Boehringer Ingelheim Investigational Site

    Ternopil,
    Ukraine

    Site Not Available

  • 1218.43.38002 Boehringer Ingelheim Investigational Site

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • 1218.43.10027 Boehringer Ingelheim Investigational Site

    Phoenix, Arizona
    United States

    Site Not Available

  • 1218.43.10011 Boehringer Ingelheim Investigational Site

    Chula Vista, California
    United States

    Site Not Available

  • 1218.43.10006 Boehringer Ingelheim Investigational Site

    Riverside, California
    United States

    Site Not Available

  • 1218.43.10021 Boehringer Ingelheim Investigational Site

    Whittier, California
    United States

    Site Not Available

  • 1218.43.10013 Boehringer Ingelheim Investigational Site

    Pembroke Pines, Florida
    United States

    Site Not Available

  • 1218.43.10009 Boehringer Ingelheim Investigational Site

    West Palm Beach, Florida
    United States

    Site Not Available

  • 1218.43.10018 Boehringer Ingelheim Investigational Site

    Decatur, Georgia
    United States

    Site Not Available

  • 1218.43.10022 Boehringer Ingelheim Investigational Site

    Chicago, Illinois
    United States

    Site Not Available

  • 1218.43.10015 Boehringer Ingelheim Investigational Site

    Shreveport, Louisiana
    United States

    Site Not Available

  • 1218.43.10016 Boehringer Ingelheim Investigational Site

    Kansas City, Missouri
    United States

    Site Not Available

  • 1218.43.10004 Boehringer Ingelheim Investigational Site

    Bronx, New York
    United States

    Site Not Available

  • 1218.43.10003 Boehringer Ingelheim Investigational Site

    Great Neck, New York
    United States

    Site Not Available

  • 1218.43.10020 Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina
    United States

    Site Not Available

  • 1218.43.10019 Boehringer Ingelheim Investigational Site

    Delaware, Ohio
    United States

    Site Not Available

  • 1218.43.10008 Boehringer Ingelheim Investigational Site

    Mentor, Ohio
    United States

    Site Not Available

  • 1218.43.10005 Boehringer Ingelheim Investigational Site

    Bethlehem, Pennsylvania
    United States

    Site Not Available

  • 1218.43.10007 Boehringer Ingelheim Investigational Site

    Carlisle, Pennsylvania
    United States

    Site Not Available

  • 1218.43.10001 Boehringer Ingelheim Investigational Site

    Providence, Rhode Island
    United States

    Site Not Available

  • 1218.43.10025 Boehringer Ingelheim Investigational Site

    Aiken, South Carolina
    United States

    Site Not Available

  • 1218.43.10023 Boehringer Ingelheim Investigational Site

    Austin, Texas
    United States

    Site Not Available

  • 1218.43.10024 Boehringer Ingelheim Investigational Site

    Austin, Texas
    United States

    Site Not Available

  • 1218.43.10014 Boehringer Ingelheim Investigational Site

    Dallas, Texas
    United States

    Site Not Available

  • 1218.43.10017 Boehringer Ingelheim Investigational Site

    Lufkin, Texas
    United States

    Site Not Available

  • 1218.43.10010 Boehringer Ingelheim Investigational Site

    Tacoma, Washington
    United States

    Site Not Available

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