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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Linagliptin (Drug); Linagliptin (Drug); Linagliptin (Drug); Placebo (Drug); Glimepiride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

Summary

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.

Clinical Details

Official title: A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: HbA1c Change From Baseline at Week 12

Secondary outcome:

Percentage of Patients With HbA1c<=7.0% at Week 12

Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12

Eligibility

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

1218.6.3304A Boehringer Ingelheim Investigational Site, Joue les Tours, France

1218.6.3305A Euraxi Pharma, Joue les Tours, France

1218.6.3302A Boehringer Ingelheim Investigational Site, Joué les Tours, France

1218.6.3303A Boehringer Ingelheim Investigational Site, Joué Les Tours, France

1218.6.3301A Boehringer Ingelheim Investigational Site, Paris cedex 13, France

1218.6.49007 Boehringer Ingelheim Investigational Site, Aschaffenburg, Germany

1218.6.49013 Boehringer Ingelheim Investigational Site, Bosenheim, Germany

1218.6.49008 Boehringer Ingelheim Investigational Site, Dresden, Germany

1218.6.49009 Boehringer Ingelheim Investigational Site, Düsseldorf, Germany

1218.6.49014 Boehringer Ingelheim Investigational Site, Heidelberg, Germany

1218.6.49012 Boehringer Ingelheim Investigational Site, Immenstadt, Germany

1218.6.49001 Boehringer Ingelheim Investigational Site, Mainz, Germany

1218.6.49005 Boehringer Ingelheim Investigational Site, Neuwied, Germany

1218.6.49017 Boehringer Ingelheim Investigational Site, Offenbach a. M., Germany

1218.6.49002 Boehringer Ingelheim Investigational Site, Saarbrücken, Germany

1218.6.49011 Boehringer Ingelheim Investigational Site, Sinsheim, Germany

1218.6.49010 Boehringer Ingelheim Investigational Site, St. Ingbert/Oberwürzbach, Germany

1218.6.49015 Boehringer Ingelheim Investigational Site, Sulzbach-Rosenberg, Germany

1218.6.49016 Boehringer Ingelheim Investigational Site, Wangen, Germany

1218.6.49003 Boehringer Ingelheim Investigational Site, Würzburg, Germany

1218.6.42103 Boehringer Ingelheim Investigational Site, Banska Bystrica, Slovakia

1218.6.42104 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1218.6.42105 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1218.6.42101 Boehringer Ingelheim Investigational Site, Nove Mesto nad Vahom, Slovakia

1218.6.46003 Boehringer Ingelheim Investigational Site, Göteborg, Sweden

1218.6.46001 Boehringer Ingelheim Investigational Site, Malmö, Sweden

1218.6.46002 Boehringer Ingelheim Investigational Site, Uddevalla, Sweden

1218.6.46004 Boehringer Ingelheim Investigational Site, Uppsala, Sweden

1218.6.38002 Boehringer Ingelheim Investigational Site, Dnyepropetrovsk, Ukraine

1218.6.38001 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1218.6.38003 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1218.6.38005 Boehringer Ingelheim Investigational Site, Kiev, Ukraine

1218.6.44012 Boehringer Ingelheim Investigational Site, Ashford, United Kingdom

1218.6.44004 Boehringer Ingelheim Investigational Site, Baillieston, Glasgow, United Kingdom

1218.6.44002 Boehringer Ingelheim Investigational Site, Bath, United Kingdom

1218.6.44003 Boehringer Ingelheim Investigational Site, Birmingham, United Kingdom

1218.6.44013 Boehringer Ingelheim Investigational Site, Camberley, United Kingdom

1218.6.44016 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom

1218.6.44007 Boehringer Ingelheim Investigational Site, Dundee, United Kingdom

1218.6.44006 Boehringer Ingelheim Investigational Site, Exeter, United Kingdom

1218.6.44005 Boehringer Ingelheim Investigational Site, Gillingham, United Kingdom

1218.6.44015 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom

1218.6.44008 Boehringer Ingelheim Investigational Site, Guildford, United Kingdom

1218.6.44017 Boehringer Ingelheim Investigational Site, Liverpool, United Kingdom

1218.6.44001 Boehringer Ingelheim Investigational Site, London, United Kingdom

1218.6.44018 Boehringer Ingelheim Investigational Site, Manchester, United Kingdom

1218.6.44009 Boehringer Ingelheim Investigational Site, Newcastle upon Tyne, United Kingdom

1218.6.44019 Boehringer Ingelheim Investigational Site, Reading, United Kingdom

Additional Information

Starting date: April 2006
Last updated: June 24, 2014

Page last updated: August 23, 2015

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