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Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

NCT ID: NCT00819091

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

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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

5 mg orally (po) once daily

Group Type ACTIVE_COMPARATOR

BI 1356

Intervention Type DRUG

5mg orally (po) tablet qd

Placebo

one tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 1356 5mg one tablet daily

Interventions

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BI 1356

5mg orally (po) tablet qd

Intervention Type DRUG

Placebo

Placebo matching BI 1356 5mg one tablet daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug

Exclusion Criteria

Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.35.10002 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1218.35.10001 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.35.10016 Boehringer Ingelheim Investigational Site

National City, California, United States

Site Status

1218.35.10017 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1218.35.10021 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1218.35.10013 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1218.35.10015 Boehringer Ingelheim Investigational Site

Flint, Michigan, United States

Site Status

1218.35.10018 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Site Status

1218.35.10004 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1218.35.10005 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

1218.35.10020 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1218.35.10009 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.35.10019 Boehringer Ingelheim Investigational Site

Sugar Land, Texas, United States

Site Status

1218.35.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1218.35.54005 Boehringer Ingelheim Investigational Site

Corrientes, , Argentina

Site Status

1218.35.54001 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1218.35.54006 Boehringer Ingelheim Investigational Site

Parque Velez Sarfield, , Argentina

Site Status

1218.35.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1218.35.36002 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1218.35.36004 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1218.35.36005 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

Site Status

1218.35.36003 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1218.35.91003 Boehringer Ingelheim Investigational Site

Aligarh, Uttar Pradesh, , India

Site Status

1218.35.91007 Boehringer Ingelheim Investigational Site

Aminjikarai, Tamilnadu, , India

Site Status

1218.35.91001 Boehringer Ingelheim Investigational Site

Bangalore, Karnataka, , India

Site Status

1218.35.91004 Boehringer Ingelheim Investigational Site

Bangalore, Karnataka, , India

Site Status

1218.35.91002 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

1218.35.91008 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, , India

Site Status

1218.35.91005 Boehringer Ingelheim Investigational Site

Nagpur, Maharashtra, , India

Site Status

1218.35.91006 Boehringer Ingelheim Investigational Site

Pune, Maharastra, , India

Site Status

1218.35.81003 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.35.81001 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, , Japan

Site Status

1218.35.81002 Boehringer Ingelheim Investigational Site

Suita, Osaka,, , Japan

Site Status

1218.35.48002 Boehringer Ingelheim Investigational Site

Bialystok, , Poland

Site Status

1218.35.48004 Boehringer Ingelheim Investigational Site

Lublin, , Poland

Site Status

1218.35.48003 Boehringer Ingelheim Investigational Site

Poznan, , Poland

Site Status

1218.35.48001 Boehringer Ingelheim Investigational Site

Rzeszów, , Poland

Site Status

1218.35.48005 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

Site Status

1218.35.70008 Boehringer Ingelheim Investigational Site

Arkhangelsk, , Russia

Site Status

1218.35.70001 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.35.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.35.70003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.35.70006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.35.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.35.70007 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

Site Status

Countries

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United States Argentina Hungary India Japan Poland Russia

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)

Lewin AJ, Arvay L, Liu D, Patel S, von Eynatten M, Woerle HJ. Efficacy and tolerability of linagliptin added to a sulfonylurea regimen in patients with inadequately controlled type 2 diabetes mellitus: an 18-week, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2012 Sep;34(9):1909-19.e15. doi: 10.1016/j.clinthera.2012.07.008. Epub 2012 Aug 29.

Reference Type DERIVED
PMID: 22939034 (View on PubMed)

Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

Reference Type DERIVED
PMID: 22234149 (View on PubMed)

Other Identifiers

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2008-003118-86

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.35

Identifier Type: -

Identifier Source: org_study_id

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