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Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

NCT ID: NCT00309608

Last Updated: 2014-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

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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 low dose

Patients receive Linagliptin low dose tablets once daily

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin low dose tablet once daily

Linagliptin medium dose

Patients receive Linagliptin medium dose tablets once daily

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin medium dose tablet once daily

Linagliptin high dose

Patients receive Linagliptin high dose tablets once daily

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin high dose tablet once daily

Placebo

Patients receive tablets identical to those containing Linagliptin low, medium and high dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once daily

Glimepiride

Patients receive Glimepiride tablets once daily

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Glimepiride tablets once daily

Interventions

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Linagliptin

Linagliptin medium dose tablet once daily

Intervention Type DRUG

Linagliptin

Linagliptin high dose tablet once daily

Intervention Type DRUG

Linagliptin

Linagliptin low dose tablet once daily

Intervention Type DRUG

Placebo

Placebo tablets once daily

Intervention Type DRUG

Glimepiride

Glimepiride tablets once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion\_Criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
* HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
* HbA1c 7.5 10.0% at screening for patients treated with metformin alone
* HbA1c 7.5 10.0% at beginning of the placebo run-in phase
* Age \> 21 and \< 75 years
* MI \> 25 and \< 40 kg/m2 (Body Mass Index)

Exclusion Criteria

Exclusion\_Criteria:

* Clinically relevant cardiovascular disease
* Impaired hepatic function
* Renal insufficiency or impaired renal function
* Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
* Treatment with insulin within 3 months prior to screening
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 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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1218.6.3302A Boehringer Ingelheim Investigational Site

Joué Les Tours, , France

Site Status

1218.6.3303A Boehringer Ingelheim Investigational Site

Joué Les Tours, , France

Site Status

1218.6.3304A Boehringer Ingelheim Investigational Site

Joué-lès-Tours, , France

Site Status

1218.6.3305A Euraxi Pharma

Joué-lès-Tours, , France

Site Status

1218.6.3301A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1218.6.49007 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1218.6.49013 Boehringer Ingelheim Investigational Site

Bosenheim, , Germany

Site Status

1218.6.49008 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1218.6.49009 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1218.6.49014 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Site Status

1218.6.49012 Boehringer Ingelheim Investigational Site

Immenstadt im Allgäu, , Germany

Site Status

1218.6.49001 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1218.6.49005 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1218.6.49017 Boehringer Ingelheim Investigational Site

Offenbach A. M., , Germany

Site Status

1218.6.49002 Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

1218.6.49010 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, , Germany

Site Status

1218.6.49011 Boehringer Ingelheim Investigational Site

Sinsheim, , Germany

Site Status

1218.6.49015 Boehringer Ingelheim Investigational Site

Sulzbach-Rosenberg, , Germany

Site Status

1218.6.49016 Boehringer Ingelheim Investigational Site

Wangen, , Germany

Site Status

1218.6.49003 Boehringer Ingelheim Investigational Site

Würzburg, , Germany

Site Status

1218.6.42103 Boehringer Ingelheim Investigational Site

Banská Bystrica, , Slovakia

Site Status

1218.6.42104 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.6.42105 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1218.6.42101 Boehringer Ingelheim Investigational Site

Nové Mesto nad Váhom, , Slovakia

Site Status

1218.6.46003 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1218.6.46001 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1218.6.46002 Boehringer Ingelheim Investigational Site

Uddevalla, , Sweden

Site Status

1218.6.46004 Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

Site Status

1218.6.38002 Boehringer Ingelheim Investigational Site

Dnyepropetrovsk, , Ukraine

Site Status

1218.6.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.6.38003 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.6.38005 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1218.6.44012 Boehringer Ingelheim Investigational Site

Ashford, , United Kingdom

Site Status

1218.6.44004 Boehringer Ingelheim Investigational Site

Baillieston, Glasgow, , United Kingdom

Site Status

1218.6.44002 Boehringer Ingelheim Investigational Site

Bath, , United Kingdom

Site Status

1218.6.44003 Boehringer Ingelheim Investigational Site

Birmingham, , United Kingdom

Site Status

1218.6.44013 Boehringer Ingelheim Investigational Site

Camberley, , United Kingdom

Site Status

1218.6.44016 Boehringer Ingelheim Investigational Site

Chorley, , United Kingdom

Site Status

1218.6.44007 Boehringer Ingelheim Investigational Site

Dundee, , United Kingdom

Site Status

1218.6.44006 Boehringer Ingelheim Investigational Site

Exeter, , United Kingdom

Site Status

1218.6.44005 Boehringer Ingelheim Investigational Site

Gillingham, , United Kingdom

Site Status

1218.6.44015 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

1218.6.44008 Boehringer Ingelheim Investigational Site

Guildford, , United Kingdom

Site Status

1218.6.44017 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

1218.6.44001 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1218.6.44018 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1218.6.44009 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

1218.6.44019 Boehringer Ingelheim Investigational Site

Reading, , United Kingdom

Site Status

Countries

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France Germany Slovakia Sweden Ukraine United Kingdom

Other Identifiers

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2005-004597-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1218.6

Identifier Type: -

Identifier Source: org_study_id

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