Clinical trial NCT00622284: Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Official title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility criteria: Inclusion criteria:

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Primary outcomes:
measure: HbA1c Change From Baseline at Week 52
timeFrame: Baseline and week 52
measure: HbA1c Change From Baseline at Week 104
timeFrame: Baseline and week 104
Secondary outcomes:
measure: Body Weight Change From Baseline at Week 52
timeFrame: Baseline and week 52
measure: Body Weight Change From Baseline at Week 104
timeFrame: Baseline and week 104
measure: Incidence of Hypoglycaemic Events up to 52 Weeks
timeFrame: Week 52
measure: Incidence of Hypoglycaemic Events up to 104 Weeks
timeFrame: Week 104
measure: Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
timeFrame: Baseline and week 52
measure: Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
timeFrame: Baseline and week 104
measure: Percentage of Patients With HbA1c <7.0% at Week 52
timeFrame: Week 52
measure: Percentage of Patients With HbA1c <7.0% at Week 104
timeFrame: Week 104
measure: Percentage of Patients With HbA1c <6.5% at Week 52
timeFrame: Week 52
measure: Percentage of Patients With HbA1c <6.5% at Week 104
timeFrame: Week 104
measure: Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
timeFrame: Week 104
measure: 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
timeFrame: Baseline and week 104
measure: HbA1c Change at Week 4
timeFrame: Baseline and week 4
measure: HbA1c Change at Week 8
timeFrame: Baseline and week 8
measure: HbA1c Change at Week 12
timeFrame: Baseline and week 12
measure: HbA1c Change at Week 16
timeFrame: Baseline and week 16
measure: HbA1c Change at Week 28
timeFrame: Baseline and week 28
measure: HbA1c Change at Week 40
timeFrame: Baseline and week 40
measure: HbA1c Change at Week 52
timeFrame: Baseline and week 52
measure: HbA1c Change at Week 65
timeFrame: Baseline and week 65
measure: HbA1c Change at Week 78
timeFrame: Baseline and week 78
measure: HbA1c Change at Week 91
timeFrame: Baseline and week 91
measure: HbA1c Change at Week 104
timeFrame: Baseline and week 104
measure: Change in Baseline Lipid Parameter Cholesterol at Week 104
timeFrame: Baseline and week 104
measure: Change in Baseline Lipid Parameter HDL at Week 104
timeFrame: Baseline and week 104
measure: Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
timeFrame: Baseline and week 104
measure: Change in Baseline Lipid Parameter Triglyceride at Week 104
timeFrame: Baseline and week 104
Other outcomes:
Locations:
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facility: 1218.20.10033 Boehringer Ingelheim Investigational Site
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city: Chula Vista
country: United States
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city: Los Angeles
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facility: 1218.20.10020 Boehringer Ingelheim Investigational Site
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facility: 1218.20.10035 Boehringer Ingelheim Investigational Site
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country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Stara Zagora
country: Bulgaria
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city: Aalborg
country: Denmark
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city: Aarhus C
country: Denmark
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city: Aarhus C
country: Denmark
facility: 1218.20.45011 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1218.20.45013 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1218.20.45002 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1218.20.45003 Boehringer Ingelheim Investigational Site
city: Odense
country: Denmark
facility: 1218.20.45007 Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3307A Boehringer Ingelheim Investigational Site
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facility: 1218.20.3307B Boehringer Ingelheim Investigational Site
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facility: 1218.20.3307C Boehringer Ingelheim Investigational Site
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facility: 1218.20.3307D Boehringer Ingelheim Investigational Site
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facility: 1218.20.3307E Boehringer Ingelheim Investigational Site
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city: Joué les Tours cedex
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facility: 1218.20.3307G Boehringer Ingelheim Investigational Site
city: Joué les Tours cedex
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facility: 1218.20.3307H Boehringer Ingelheim Investigational Site
city: Joué les Tours cedex
country: France
facility: 1218.20.3307I Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3310A Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3310B Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3310C Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3310D Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3310E Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
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facility: 1218.20.3312A Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3312B Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3312C Boehringer Ingelheim Investigational Site
city: Joué les Tours Cedex
country: France
facility: 1218.20.3312D Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3308A Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3308C Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3308D Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3308E Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3308F Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3309A Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3309B Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3309C Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3309D Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3309E Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3311A Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3311B Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3311C Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3313A Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3313B Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3313C Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3313D Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314A Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314B Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314C Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314D Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314E Boehringer Ingelheim Investigational Site
city: Joué les Tours
country: France
facility: 1218.20.3314F Boehringer Ingelheim Investigational Site
city: Nantes Cedex 1
country: France
facility: 1218.20.3301A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302C Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302E Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302G Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3302I Boehringer Ingelheim Investigational Site
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country: France
facility: 1218.20.3303A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303C Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303E Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303G Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3303I Boehringer Ingelheim Investigational Site
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country: France
facility: 1218.20.3304A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3304B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3304C Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3304D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3304F Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3304H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3305A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3305B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3305H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306F Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306G Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1218.20.3306I Boehringer Ingelheim Investigational Site
city: Potigny
country: France
facility: 1218.20.3311D Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1218.20.49004 Boehringer Ingelheim Investigational Site
city: Bad Mergentheim
country: Germany
facility: 1218.20.49028 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1218.20.49022 Boehringer Ingelheim Investigational Site
city: Bosenheim
country: Germany
facility: 1218.20.49024 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1218.20.49020 Boehringer Ingelheim Investigational Site
city: Flörsheim
country: Germany
facility: 1218.20.49018 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 1218.20.49015 Boehringer Ingelheim Investigational Site
city: Großheirath
country: Germany
facility: 1218.20.49006 Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: 1218.20.49025 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1218.20.49016 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1218.20.49029 Boehringer Ingelheim Investigational Site
city: Hatten
country: Germany
facility: 1218.20.49021 Boehringer Ingelheim Investigational Site
city: Kelkheim
country: Germany
facility: 1218.20.49017 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1218.20.49012 Boehringer Ingelheim Investigational Site
city: Künzing
country: Germany
facility: 1218.20.49005 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1218.20.49010 Boehringer Ingelheim Investigational Site
city: Neuwied
country: Germany
facility: 1218.20.49003 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1218.20.49007 Boehringer Ingelheim Investigational Site
city: Rednitzhembach
country: Germany
facility: 1218.20.49008 Boehringer Ingelheim Investigational Site
city: Saaldorf-Surheim
country: Germany
facility: 1218.20.49027 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1218.20.49014 Boehringer Ingelheim Investigational Site
city: Speyer
country: Germany
facility: 1218.20.49030 Boehringer Ingelheim Investigational Site
city: St. Ingbert/Oberwürzbach
country: Germany
facility: 1218.20.49019 Boehringer Ingelheim Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: 1218.20.49002 Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: 1218.20.49009 Boehringer Ingelheim Investigational Site
city: Wangen
country: Germany
facility: 1218.20.49026 Boehringer Ingelheim Investigational Site
city: Westerkappeln
country: Germany
facility: 1218.20.49011 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1218.20.49013 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1218.20.85201 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1218.20.85202 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1218.20.85204 Boehringer Ingelheim Investigational Site
city: Ajka
country: Hungary
facility: 1218.20.36208 Boehringer Ingelheim Investigational Site
city: Baja
country: Hungary
facility: 1218.20.36205 Boehringer Ingelheim Investigational Site
city: Békéscsaba
country: Hungary
facility: 1218.20.36204 Boehringer Ingelheim Investigational Site
city: Hódmezövásárhely
country: Hungary
facility: 1218.20.36206 Boehringer Ingelheim Investigational Site
city: Makó
country: Hungary
facility: 1218.20.36202 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1218.20.36201 Boehringer Ingelheim Investigational Site
city: Mosonmagyarovar
country: Hungary
facility: 1218.20.36207 Boehringer Ingelheim Investigational Site
city: Szentes
country: Hungary
facility: 1218.20.36203 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1218.20.91022 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 1218.20.91024 Boehringer Ingelheim Investigational Site
city: Gujarat
country: India
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city: Hyderabad
country: India
facility: 1218.20.91023 Boehringer Ingelheim Investigational Site
city: Kochi
country: India
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city: Mumbai
country: India
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city: Patna
country: India
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city: Tamilnadu
country: India
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city: Co. Cork
country: Ireland
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country: Ireland
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city: Co. Wexford
country: Ireland
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city: Co. Wexford
country: Ireland
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city: Dublin
country: Ireland
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country: Ireland
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city: Catania
country: Italy
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city: Chieti
country: Italy
facility: 1218.20.39027 Boehringer Ingelheim Investigational Site
city: Codogno (lo)
country: Italy
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city: Genova
country: Italy
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city: Perugia
country: Italy
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city: Pordenone
country: Italy
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city: Ravenna
country: Italy
facility: 1218.20.39028 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1218.20.39030 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1218.20.39032 Boehringer Ingelheim Investigational Site
city: Siena
country: Italy
facility: 1218.20.39020 Boehringer Ingelheim Investigational Site
city: 's Hertogenbosch
country: Netherlands
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city: Almere
country: Netherlands
facility: 1218.20.31014 Boehringer Ingelheim Investigational Site
city: Beek en Donk
country: Netherlands
facility: 1218.20.31016 Boehringer Ingelheim Investigational Site
city: Ewijk
country: Netherlands
facility: 1218.20.31011 Boehringer Ingelheim Investigational Site
city: Hoogwoud
country: Netherlands
facility: 1218.20.31018 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1218.20.31012 Boehringer Ingelheim Investigational Site
city: Rilland
country: Netherlands
facility: 1218.20.31022 Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: 1218.20.31019 Boehringer Ingelheim Investigational Site
city: Wildervank
country: Netherlands
facility: 1218.20.31013 Boehringer Ingelheim Investigational Site
city: Fevik
country: Norway
facility: 1218.20.47005 Boehringer Ingelheim Investigational Site
city: Fornebu
country: Norway
facility: 1218.20.47004 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1218.20.47002 Boehringer Ingelheim Investigational Site
city: RUD
country: Norway
facility: 1218.20.47001 Boehringer Ingelheim Investigational Site
city: Sandvika
country: Norway
facility: 1218.20.47003 Boehringer Ingelheim Investigational Site
city: Bialystok
country: Poland
facility: 1218.20.48210 Boehringer Ingelheim Investigational Site
city: Gdynia
country: Poland
facility: 1218.20.48208 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1218.20.48207 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1218.20.48201 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1218.20.48202 Boehringer Ingelheim Investigational Site
city: Olsztyn
country: Poland
facility: 1218.20.48203 Boehringer Ingelheim Investigational Site
city: Torun
country: Poland
facility: 1218.20.48206 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1218.20.48205 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1218.20.48209 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 1218.20.27007 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1218.20.27002 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1218.20.27006 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1218.20.27004 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1218.20.27005 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1218.20.27003 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1218.20.46003 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1218.20.46001 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1218.20.46002 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1218.20.46004 Boehringer Ingelheim Investigational Site
city: Baillieston, Glasgow
country: United Kingdom
facility: 1218.20.44108 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1218.20.44115 Boehringer Ingelheim Investigational Site
city: Bradford on Avon
country: United Kingdom
facility: 1218.20.44110 Boehringer Ingelheim Investigational Site
city: Buckshaw Village, Chorley
country: United Kingdom
facility: 1218.20.44102 Boehringer Ingelheim Investigational Site
city: Cheadle
country: United Kingdom
facility: 1218.20.44114 Boehringer Ingelheim Investigational Site
city: Chestfield, Whitstable
country: United Kingdom
facility: 1218.20.44116 Boehringer Ingelheim Investigational Site
city: Chippenham
country: United Kingdom
facility: 1218.20.44109 Boehringer Ingelheim Investigational Site
city: Dundee
country: United Kingdom
facility: 1218.20.44113 Boehringer Ingelheim Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: 1218.20.44105 Boehringer Ingelheim Investigational Site
city: Ely
country: United Kingdom
facility: 1218.20.44112 Boehringer Ingelheim Investigational Site
city: Guildford
country: United Kingdom
facility: 1218.20.44101 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1218.20.44103 Boehringer Ingelheim Investigational Site
city: Trowbridge
country: United Kingdom
facility: 1218.20.44106 Boehringer Ingelheim Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: 1218.20.44104 Boehringer Ingelheim Investigational Site
city: Westbury
country: United Kingdom
facility: 1218.20.44111 Boehringer Ingelheim Investigational Site
city: Whitstable
country: United Kingdom
facility: 1218.20.44107 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Gallwitz B, Rosenstock J, Emser A, von Eynatten M, Woerle HJ. Linagliptin is more effective than glimepiride at achieving a composite outcome of target HbA(1)c < 7% with no hypoglycaemia and no weight gain over 2 years. Int J Clin Pract. 2013 Apr;67(4):317-21. doi: 10.1111/ijcp.12101.
citation: Gallwitz B, Rosenstock J, Rauch T, Bhattacharya S, Patel S, von Eynatten M, Dugi KA, Woerle HJ. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):475-83. doi: 10.1016/S0140-6736(12)60691-6. Epub 2012 Jun 28.
citation: 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.