Clinical trial NCT00309608: Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 333
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: HbA1c Change From Baseline at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of Patients With HbA1c<=7.0% at Week 12
timeFrame: week 12
measure: Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Joue les Tours
country: France
facility: 1218.6.3304A Boehringer Ingelheim Investigational Site
city: Joue les Tours
country: France
facility: 1218.6.3305A Euraxi Pharma
city: Joué les Tours
country: France
facility: 1218.6.3302A Boehringer Ingelheim Investigational Site
city: Joué Les Tours
country: France
facility: 1218.6.3303A Boehringer Ingelheim Investigational Site
city: Paris cedex 13
country: France
facility: 1218.6.3301A Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1218.6.49007 Boehringer Ingelheim Investigational Site
city: Bosenheim
country: Germany
facility: 1218.6.49013 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1218.6.49008 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1218.6.49009 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1218.6.49014 Boehringer Ingelheim Investigational Site
city: Immenstadt
country: Germany
facility: 1218.6.49012 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1218.6.49001 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1218.6.49005 Boehringer Ingelheim Investigational Site
city: Offenbach a. M.
country: Germany
facility: 1218.6.49017 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1218.6.49002 Boehringer Ingelheim Investigational Site
city: Sinsheim
country: Germany
facility: 1218.6.49011 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1218.6.49010 Boehringer Ingelheim Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: 1218.6.49015 Boehringer Ingelheim Investigational Site
city: Wangen
country: Germany
facility: 1218.6.49016 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1218.6.49003 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1218.6.42103 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.6.42104 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1218.6.42105 Boehringer Ingelheim Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: 1218.6.42101 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1218.6.46003 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1218.6.46001 Boehringer Ingelheim Investigational Site
city: Uddevalla
country: Sweden
facility: 1218.6.46002 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1218.6.46004 Boehringer Ingelheim Investigational Site
city: Dnyepropetrovsk
country: Ukraine
facility: 1218.6.38002 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.6.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.6.38003 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1218.6.38005 Boehringer Ingelheim Investigational Site
city: Ashford
country: United Kingdom
facility: 1218.6.44012 Boehringer Ingelheim Investigational Site
city: Baillieston, Glasgow
country: United Kingdom
facility: 1218.6.44004 Boehringer Ingelheim Investigational Site
city: Bath
country: United Kingdom
facility: 1218.6.44002 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 1218.6.44003 Boehringer Ingelheim Investigational Site
city: Camberley
country: United Kingdom
facility: 1218.6.44013 Boehringer Ingelheim Investigational Site
city: Chorley
country: United Kingdom
facility: 1218.6.44016 Boehringer Ingelheim Investigational Site
city: Dundee
country: United Kingdom
facility: 1218.6.44007 Boehringer Ingelheim Investigational Site
city: Exeter
country: United Kingdom
facility: 1218.6.44006 Boehringer Ingelheim Investigational Site
city: Gillingham
country: United Kingdom
facility: 1218.6.44005 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1218.6.44015 Boehringer Ingelheim Investigational Site
city: Guildford
country: United Kingdom
facility: 1218.6.44008 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 1218.6.44017 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1218.6.44001 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1218.6.44018 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1218.6.44009 Boehringer Ingelheim Investigational Site
city: Reading
country: United Kingdom
facility: 1218.6.44019 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: