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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01649297




Registration number
NCT01649297
Ethics application status
Date submitted
23/07/2012
Date registered
25/07/2012
Date last updated
23/07/2015

Titles & IDs
Public title
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Scientific title
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Secondary ID [1] 0 0
2012-000905-53
Secondary ID [2] 0 0
1276.10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - empagliflozin (low dose qd)
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - Empagliflozin (high dose qd)
Treatment: Drugs - empagliflozin (high dose bid)
Treatment: Drugs - Placebo
Treatment: Drugs - empagliflozin (low dose bid)

Experimental: empagliflozin (high dose qd) - Patients receive Empagliflozin high dose once daily

Experimental: empagliflozin (high dose bid) - Patients receive Empagliflozin high dose split twice daily

Experimental: empagliflozin (low dose qd) - Patients receive Empagliflozin low dose once daily

Experimental: empagliflozin (low dose bid) - Patients receive Empagliflozin low dose split twice daily

Placebo comparator: Placebo - Patients receive placebo matching Empagliflozin


Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Treatment: Drugs: empagliflozin (low dose qd)
Patients receive Empagliflozin low dose once daily

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose qd)

Treatment: Drugs: Placebo
Patients receive placebo matching empagliflozin (low dose bid)

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose bid)

Treatment: Drugs: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose once daily

Treatment: Drugs: empagliflozin (high dose bid)
Patients receive Empagliflozin high dose split twice daily

Treatment: Drugs: Placebo
Patients receive placebo matching Empagliflozin (high dose qd)

Treatment: Drugs: empagliflozin (low dose bid)
Patients receive Empagliflozin low dose split twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Timepoint [1] 0 0
Baseline and 16 weeks
Secondary outcome [1] 0 0
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Timepoint [1] 0 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age>=18 at Visit 1
5. body mass index <=45 kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula) screening and/or run-in
2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
983
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
1276.10.61002 Boehringer Ingelheim Investigational Site - Wollongong
Recruitment hospital [2] 0 0
1276.10.61001 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Maine
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Michigan
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Mississippi
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Washington
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Canada
State/province [20] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Estonia
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Pärnu
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Estonia
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Tallinn
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Estonia
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Viljandi County
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France
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Aire sur l'Adour
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France
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Bischheim
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France
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Bourg des Comptes
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France
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Bourges
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France
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Broglie
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France
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Mont de Marsan
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France
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Paris
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France
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Saint Vinecnt de Tyrosse
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France
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Segre
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France
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Strasbourg
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Georgia
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Tbilisi
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Nürnberg
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Germany
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Rehlingen-Siersburg
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Guatemala
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Guatemala Ciudad
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Guatemala
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Quetzaltenango Ciudad
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Italy
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Italy
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Bologna
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Catanzaro
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Napoli
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Italy
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Palermo
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Roma
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Italy
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Torino
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Daugavpils
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Ogre
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Riga
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Tukums
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Mexico
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Ciudad de Mexico
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Mexico
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Durango
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Mexico
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Pachuca
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Mexico
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Tijuana
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New Zealand
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Christchurch
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New Zealand
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Greenlane East Auckland NZ
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Poland
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Bialystok
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Poland
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Gizycko
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Warszawa
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Paarl
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South Africa
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Parow
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South Africa
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Plumstead, Cape Town
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South Africa
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Pretoria
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South Africa
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Somerset West
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Les Borges del Camp
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Spain
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Sant Adria del Besos
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Spain
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Vic
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Ukraine
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Kharkiv
Country [86] 0 0
Ukraine
State/province [86] 0 0
Kiev
Country [87] 0 0
Ukraine
State/province [87] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
Trial website
https://clinicaltrials.gov/study/NCT01649297
Trial related presentations / publications
Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01649297