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A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

NCT ID: NCT00740051

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

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

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BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes

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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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Linagliptin

52 week treatment

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

5mg once daily

Placebo

First 18 weeks of treatment

Group Type PLACEBO_COMPARATOR

Linagliptin Placebo

Intervention Type DRUG

0 mg placebo comparator for part 1 of study (to 18 weeks)

Glimepiride

Placebo patients switch to glimepiride week19-52

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

1-4mg for part 2 of study (weeks 19-52)

Interventions

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Linagliptin

5mg once daily

Intervention Type DRUG

Linagliptin Placebo

0 mg placebo comparator for part 1 of study (to 18 weeks)

Intervention Type DRUG

Glimepiride

1-4mg for part 2 of study (weeks 19-52)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones 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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1218.50.10009 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1218.50.10011 Boehringer Ingelheim Investigational Site

Peoria, Arizona, United States

Site Status

1218.50.10013 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Site Status

1218.50.10016 Boehringer Ingelheim Investigational Site

Harbor City, California, United States

Site Status

1218.50.10017 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Site Status

1218.50.10006 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1218.50.10007 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1218.50.10004 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Site Status

1218.50.10002 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Site Status

1218.50.10015 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1218.50.10005 Boehringer Ingelheim Investigational Site

Kingsport, Tennessee, United States

Site Status

1218.50.10012 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.50.10022 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1218.50.10010 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.50.10018 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1218.50.11001 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1218.50.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1218.50.11005 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1218.50.11002 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Site Status

1218.50.11004 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1218.50.52007 Boehringer Ingelheim Investigational Site

Aguascalientes, , Mexico

Site Status

1218.50.52010 Boehringer Ingelheim Investigational Site

Guadalajara, , Mexico

Site Status

1218.50.52009 Boehringer Ingelheim Investigational Site

León, , Mexico

Site Status

1218.50.52002 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.50.52004 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.50.52005 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.50.52008 Boehringer Ingelheim Investigational Site

México, , Mexico

Site Status

1218.50.52001 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1218.50.52003 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

Site Status

1218.50.63003 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1218.50.63005 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1218.50.63006 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1218.50.63008 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1218.50.63001 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

Site Status

1218.50.63004 Boehringer Ingelheim Investigational Site

Marikina City, , Philippines

Site Status

1218.50.63007 Boehringer Ingelheim Investigational Site

Pasay, , Philippines

Site Status

1218.50.63002 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

Site Status

1218.50.63009 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

Site Status

1218.50.40004 Boehringer Ingelheim Investigational Site

Brasov, , Romania

Site Status

1218.50.40001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1218.50.40002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

Site Status

1218.50.40005 Boehringer Ingelheim Investigational Site

Galati, , Romania

Site Status

1218.50.40003 Boehringer Ingelheim Investigational Site

Sibiu, , Romania

Site Status

1218.50.70001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.50.70003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1218.50.70002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.50.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.50.70005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1218.50.38002 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1218.50.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.50.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.50.38003 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1218.50.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, , Ukraine

Site Status

Countries

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United States Canada Mexico Philippines Romania Russia Ukraine

References

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Barnett AH, Patel S, Harper R, Toorawa R, Thiemann S, von Eynatten M, Woerle HJ. Linagliptin monotherapy in type 2 diabetes patients for whom metformin is inappropriate: an 18-week randomized, double-blind, placebo-controlled phase III trial with a 34-week active-controlled extension. Diabetes Obes Metab. 2012 Dec;14(12):1145-54. doi: 10.1111/dom.12011. Epub 2012 Oct 1.

Reference Type DERIVED
PMID: 22974280 (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)

Related Links

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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.50_Literature.pdf

Related Info

Other Identifiers

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2007-007485-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.50

Identifier Type: -

Identifier Source: org_study_id

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