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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

NCT ID: NCT00800683

Last Updated: 2014-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 1356

patient to receive a tablet containing BI 1356 once daily

Group Type EXPERIMENTAL

BI 1356

Intervention Type DRUG

BI 1356 dosed once daily

placebo

patient to receive a tablet identical to BI 1356 once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo matching BI 1356 taken once daily

Interventions

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BI 1356

BI 1356 dosed once daily

Intervention Type DRUG

placebo

placebo matching BI 1356 taken once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.43.10027 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1218.43.10011 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Site Status

1218.43.10006 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Site Status

1218.43.10021 Boehringer Ingelheim Investigational Site

Whittier, California, United States

Site Status

1218.43.10013 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

1218.43.10009 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Site Status

1218.43.10018 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1218.43.10022 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1218.43.10015 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Site Status

1218.43.10016 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

1218.43.10003 Boehringer Ingelheim Investigational Site

Great Neck, New York, United States

Site Status

1218.43.10004 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Site Status

1218.43.10020 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

1218.43.10019 Boehringer Ingelheim Investigational Site

Delaware, Ohio, United States

Site Status

1218.43.10008 Boehringer Ingelheim Investigational Site

Mentor, Ohio, United States

Site Status

1218.43.10005 Boehringer Ingelheim Investigational Site

Bethlehem, Pennsylvania, United States

Site Status

1218.43.10007 Boehringer Ingelheim Investigational Site

Carlisle, Pennsylvania, United States

Site Status

1218.43.10001 Boehringer Ingelheim Investigational Site

Providence, Rhode Island, United States

Site Status

1218.43.10025 Boehringer Ingelheim Investigational Site

Aiken, South Carolina, United States

Site Status

1218.43.10023 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1218.43.10024 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

1218.43.10014 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.43.10017 Boehringer Ingelheim Investigational Site

Lufkin, Texas, United States

Site Status

1218.43.10010 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

1218.43.61009 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Site Status

1218.43.61010 Boehringer Ingelheim Investigational Site

Auchenflower, Queensland, Australia

Site Status

1218.43.61006 Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

1218.43.61007 Boehringer Ingelheim Investigational Site

Reservoir, Victoria, Australia

Site Status

1218.43.61011 Boehringer Ingelheim Investigational Site

Richmond, Victoria, Australia

Site Status

1218.43.61005 Boehringer Ingelheim Investigational Site

Adelaide, SA, , Australia

Site Status

1218.43.61002 Boehringer Ingelheim Investigational Site

Herston, QLD, , Australia

Site Status

1218.43.85201 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Site Status

1218.43.85203 Boehringer Ingelheim Investigational Site

New Territories, , Hong Kong

Site Status

1218.43.97008 Boehringer Ingelheim Investigational Site

Afula, , Israel

Site Status

1218.43.97005 Boehringer Ingelheim Investigational Site

Ashkelon, , Israel

Site Status

1218.43.97003 Boehringer Ingelheim Investigational Site

Haifa, , Israel

Site Status

1218.43.97004 Boehringer Ingelheim Investigational Site

Jerusalem, , Israel

Site Status

1218.43.97009 Boehringer Ingelheim Investigational Site

Jerusalem, , Israel

Site Status

1218.43.97002 Boehringer Ingelheim Investigational Site

Kfar Saba, , Israel

Site Status

1218.43.97007 Boehringer Ingelheim Investigational Site

Nahariya, , Israel

Site Status

1218.43.97001 Boehringer Ingelheim Investigational Site

Safed, , Israel

Site Status

1218.43.97006 Boehringer Ingelheim Investigational Site

Tel Aviv, , Israel

Site Status

1218.43.64001 Boehringer Ingelheim Investigational Site

Auckland, , New Zealand

Site Status

1218.43.64003 Boehringer Ingelheim Investigational Site

Christchurch, , New Zealand

Site Status

1218.43.64004 Boehringer Ingelheim Investigational Site

Takpuna, , New Zealand

Site Status

1218.43.64002 Boehringer Ingelheim Investigational Site

Tauranga, , New Zealand

Site Status

1218.43.38003 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.43.38004 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.43.38006 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.43.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.43.38007 Boehringer Ingelheim Investigational Site

Luhansk, , Ukraine

Site Status

1218.43.38008 Boehringer Ingelheim Investigational Site

Ternopil, , Ukraine

Site Status

1218.43.38002 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Australia Hong Kong Israel New Zealand Ukraine

References

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McGill JB, Barnett AH, Lewin AJ, Patel S, Neubacher D, von Eynatten M, Woerle HJ. Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with moderate-to-severe renal impairment. Diab Vasc Dis Res. 2014 Jan;11(1):34-40. doi: 10.1177/1479164113507068. Epub 2013 Oct 29.

Reference Type DERIVED
PMID: 24169807 (View on PubMed)

Other Identifiers

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2008-001569-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.43

Identifier Type: -

Identifier Source: org_study_id

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