Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes

May 16, 2014 updated by: Boehringer Ingelheim

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • 1245.23.20032 Boehringer Ingelheim Investigational Site
      • Edmonton, Alberta, Canada
        • 1245.23.20023 Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1245.23.20028 Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada
        • 1245.23.20033 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Paradise, Newfoundland and Labrador, Canada
        • 1245.23.20024 Boehringer Ingelheim Investigational Site
      • St. John's, Newfoundland and Labrador, Canada
        • 1245.23.20031 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1245.23.20026 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie, Ontario, Canada
        • 1245.23.20001 Boehringer Ingelheim Investigational Site
      • Brampton, Ontario, Canada
        • 1245.23.20022 Boehringer Ingelheim Investigational Site
      • Corunna, Ontario, Canada
        • 1245.23.20035 Boehringer Ingelheim Investigational Site
      • Etobicoke, Ontario, Canada
        • 1245.23.20030 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada
        • 1245.23.20037 Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada
        • 1245.23.20029 Boehringer Ingelheim Investigational Site
      • Markham, Ontario, Canada
        • 1245.23.20003 Boehringer Ingelheim Investigational Site
      • Oakville, Ontario, Canada
        • 1245.23.20040 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1245.23.20034 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1245.23.20039 Boehringer Ingelheim Investigational Site
    • Quebec
      • Laval, Quebec, Canada
        • 1245.23.20027 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1245.23.20025 Boehringer Ingelheim Investigational Site
      • Sherbrooke, Quebec, Canada
        • 1245.23.20036 Boehringer Ingelheim Investigational Site
      • Ville Saint-Laurent, Quebec, Canada
        • 1245.23.20038 Boehringer Ingelheim Investigational Site
  • China
      • Beijing, China
        • 1245.23.86031 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1245.23.86032 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1245.23.86033 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1245.23.86034 Boehringer Ingelheim Investigational Site
      • Beijing, China
        • 1245.23.86035 Boehringer Ingelheim Investigational Site
      • Chengdu, China
        • 1245.23.86048 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 1245.23.86058 Boehringer Ingelheim Investigational Site
      • Dalian, China
        • 1245.23.86038 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1245.23.86002 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 1245.23.86052 Boehringer Ingelheim Investigational Site
      • Haerbin, China
        • 1245.23.86037 Boehringer Ingelheim Investigational Site
      • Jinan, China
        • 1245.23.86049 Boehringer Ingelheim Investigational Site
      • Jinan, China
        • 1245.23.86053 Boehringer Ingelheim Investigational Site
      • Nan Ning, China
        • 1245.23.86055 Boehringer Ingelheim Investigational Site
      • Nan Ning, China
        • 1245.23.86056 Boehringer Ingelheim Investigational Site
      • Nanjing, China
        • 1245.23.86042 Boehringer Ingelheim Investigational Site
      • Nanjing, China
        • 1245.23.86043 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1245.23.86039 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 1245.23.86040 Boehringer Ingelheim Investigational Site
      • Shantou, China
        • 1245.23.86054 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 1245.23.86057 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 1245.23.86045 Boehringer Ingelheim Investigational Site
      • Suzhou, China
        • 1245.23.86013 Boehringer Ingelheim Investigational Site
      • Tianjin, China
        • 1245.23.86036 Boehringer Ingelheim Investigational Site
      • Xi'An, China
        • 1245.23.86041 Boehringer Ingelheim Investigational Site
      • Zhenjiang, China
        • 1245.23.86051 Boehringer Ingelheim Investigational Site
  • France
      • Arras, France
        • 1245.23.33015 Boehringer Ingelheim Investigational Site
      • Bersée, France
        • 1245.23.33008 Boehringer Ingelheim Investigational Site
      • Bischheim, France
        • 1245.23.33020 Boehringer Ingelheim Investigational Site
      • Bondy Cedex, France
        • 1245.23.33002 Boehringer Ingelheim Investigational Site
      • Bruay La Buissiere, France
        • 1245.23.33016 Boehringer Ingelheim Investigational Site
      • Corbeil Essonnes, France
        • 1245.23.33001 Boehringer Ingelheim Investigational Site
      • Croix, France
        • 1245.23.33010 Boehringer Ingelheim Investigational Site
      • Hautmont, France
        • 1245.23.33009 Boehringer Ingelheim Investigational Site
      • La Rochelle Cedex 1, France
        • 1245.23.33003 Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 1245.23.33045 Boehringer Ingelheim Investigational Site
      • Mundolsheim, France
        • 1245.23.33014 Boehringer Ingelheim Investigational Site
      • Narbonne Cedex, France
        • 1245.23.33004 Boehringer Ingelheim Investigational Site
      • Schiltigheim, France
        • 1245.23.33012 Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1245.23.33013 Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1245.23.33019 Boehringer Ingelheim Investigational Site
      • Vieux Condé, France
        • 1245.23.33007 Boehringer Ingelheim Investigational Site
      • Wattrelos, France
        • 1245.23.33018 Boehringer Ingelheim Investigational Site
  • Germany
      • Dormagen, Germany
        • 1245.23.49001 Boehringer Ingelheim Investigational Site
      • Flörsheim, Germany
        • 1245.23.49009 Boehringer Ingelheim Investigational Site
      • Hatten, Germany
        • 1245.23.49004 Boehringer Ingelheim Investigational Site
      • Künzing, Germany
        • 1245.23.49007 Boehringer Ingelheim Investigational Site
      • Neuwied, Germany
        • 1245.23.49002 Boehringer Ingelheim Investigational Site
      • Nürnberg, Germany
        • 1245.23.49008 Boehringer Ingelheim Investigational Site
      • Rednitzhembach, Germany
        • 1245.23.49010 Boehringer Ingelheim Investigational Site
      • Rehburg-Loccum, Germany
        • 1245.23.49006 Boehringer Ingelheim Investigational Site
      • Rehlingen-Siersburg, Germany
        • 1245.23.49011 Boehringer Ingelheim Investigational Site
      • Saarbrücken, Germany
        • 1245.23.49005 Boehringer Ingelheim Investigational Site
      • Unterschneidheim, Germany
        • 1245.23.49003 Boehringer Ingelheim Investigational Site
  • India
      • Coimbatore, India
        • 1245.23.91101 Boehringer Ingelheim Investigational Site
      • Indore, India
        • 1245.23.91104 Boehringer Ingelheim Investigational Site
      • Maharashtra, India
        • 1245.23.91103 Boehringer Ingelheim Investigational Site
      • Nagpur, India
        • 1245.23.91102 Boehringer Ingelheim Investigational Site
      • Pune, India
        • 1245.23.91105 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Anyang, Korea, Republic of
        • 1245.23.82012 Boehringer Ingelheim Investigational Site
      • Busan, Korea, Republic of
        • 1245.23.82004 Boehringer Ingelheim Investigational Site
      • Goyang, Korea, Republic of
        • 1245.23.82011 Boehringer Ingelheim Investigational Site
      • Ilsan, Korea, Republic of
        • 1245.23.82009 Boehringer Ingelheim Investigational Site
      • Incheon, Korea, Republic of
        • 1245.23.82001 Boehringer Ingelheim Investigational Site
      • Jeonju, Korea, Republic of
        • 1245.23.82006 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.23.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.23.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.23.82008 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.23.82010 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1245.23.82014 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 1245.23.82002 Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • 1245.23.82003 Boehringer Ingelheim Investigational Site
  • Mexico
      • Guadalajara, Mexico
        • 1245.23.52003 Boehringer Ingelheim Investigational Site
      • Guadalajara, Mexico
        • 1245.23.52004 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1245.23.52001 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1245.23.52002 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • 1245.23.74005 Boehringer Ingelheim Investigational Site
      • Lucenec, Slovakia
        • 1245.23.74002 Boehringer Ingelheim Investigational Site
      • Nitra, Slovakia
        • 1245.23.74006 Boehringer Ingelheim Investigational Site
      • Nove Zamky, Slovakia
        • 1245.23.74014 Boehringer Ingelheim Investigational Site
      • Povazska Bystrica, Slovakia
        • 1245.23.74001 Boehringer Ingelheim Investigational Site
      • Presov, Slovakia
        • 1245.23.74004 Boehringer Ingelheim Investigational Site
      • Trebisov, Slovakia
        • 1245.23.74003 Boehringer Ingelheim Investigational Site
  • Slovenia
      • Celje, Slovenia
        • 1245.23.38003 Boehringer Ingelheim Investigational Site
      • Koper, Slovenia
        • 1245.23.38002 Boehringer Ingelheim Investigational Site
      • Maribor, Slovenia
        • 1245.23.38001 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan
        • 1245.23.88010 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1245.23.88011 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1245.23.88012 Boehringer Ingelheim Investigational Site
      • Kaohsiung, Taiwan
        • 1245.23.88013 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1245.23.88009 Boehringer Ingelheim Investigational Site
      • Tainan, Taiwan
        • 1245.23.88014 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1245.23.88006 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1245.23.88007 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1245.23.88021 Boehringer Ingelheim Investigational Site
      • Taoyuan County, Taiwan
        • 1245.23.88008 Boehringer Ingelheim Investigational Site
  • Turkey
      • Erzurum, Turkey
        • 1245.23.90003 Boehringer Ingelheim Investigational Site
      • Gaziantep, Turkey
        • 1245.23.90001 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1245.23.90002 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1245.23.90006 Boehringer Ingelheim Investigational Site
      • Istanbul, Turkey
        • 1245.23.90007 Boehringer Ingelheim Investigational Site
      • Izmir, Turkey
        • 1245.23.90004 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 1245.23.10145 Boehringer Ingelheim Investigational Site
    • Arizona
      • Tempe, Arizona, United States
        • 1245.23.10046 Boehringer Ingelheim Investigational Site
    • California
      • Huntington Park, California, United States
        • 1245.23.10095 Boehringer Ingelheim Investigational Site
      • Huntington Park, California, United States
        • 1245.23.10109 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1245.23.10074 Boehringer Ingelheim Investigational Site
      • Rancho Cucamonga, California, United States
        • 1245.23.10149 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States
        • 1245.23.10127 Boehringer Ingelheim Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • 1245.23.10042 Boehringer Ingelheim Investigational Site
      • Jupiter, Florida, United States
        • 1245.23.10133 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, United States
        • 1245.23.10080 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • 1245.23.10001 Boehringer Ingelheim Investigational Site
    • Iowa
      • Des Moines, Iowa, United States
        • 1245.23.10159 Boehringer Ingelheim Investigational Site
    • Kansas
      • Arkansas City, Kansas, United States
        • 1245.23.10117 Boehringer Ingelheim Investigational Site
      • Newton, Kansas, United States
        • 1245.23.10157 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 1245.23.10148 Boehringer Ingelheim Investigational Site
    • New York
      • Rochester, New York, United States
        • 1245.23.10034 Boehringer Ingelheim Investigational Site
      • Smithtown, New York, United States
        • 1245.23.10123 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1245.23.10120 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1245.23.10031 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • 1245.23.10158 Boehringer Ingelheim Investigational Site
      • Simpsonville, South Carolina, United States
        • 1245.23.10015 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, United States
        • 1245.23.10156 Boehringer Ingelheim Investigational Site
      • Hurst, Texas, United States
        • 1245.23.10153 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 1245.23.10143 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1245.23.10106 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent

  2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.

    Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label

  3. HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
  4. Age> or = 18
  5. Body Mass Index (BM)I < or = 45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
  6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day)
  2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
  3. Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent
  4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
  5. Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase
  6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
  7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
  8. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
  9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
  11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Typ 2 Diabetes

  12. Pre-menopausal women (last menstruation ¿ 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner
  13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
  14. Participation in another trial with an investigational drug within 30 days prior to informed consent
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 10773 Arm 2
BI 10773 once daily high dose
Drug: Placebo identical to BI 10773 low dose
Placebo tablets matching BI 10773 low dose
Drug: BI 10773
BI 10773 tablets once daily high dose open label
Drug: BI 10773
BI 10773 tablets once daily high dose
Drug: BI 10773
BI 10773 tablets once daily low dose
Placebo Comparator: Placebo
Placebo matching BI 10773
Drug: Placebo identical to BI 10773 low dose
Placebo tablets matching BI 10773 low dose
Drug: Placebo identical to BI 10773 high dose
Placebo tablets matching BI 10773 high dose
Experimental: BI 10773 open-label
BI 10773 once daily high dose open label
Drug: BI 10773
BI 10773 tablets once daily high dose open label
Drug: BI 10773
BI 10773 tablets once daily high dose
Drug: BI 10773
BI 10773 tablets once daily low dose
Experimental: BI 10773 Arm 1
BI 10773 once daily low dose
Drug: BI 10773
BI 10773 tablets once daily high dose open label
Drug: BI 10773
BI 10773 tablets once daily high dose
Drug: BI 10773
BI 10773 tablets once daily low dose
Drug: Placebo identical to BI 10773 high dose
Placebo tablets matching BI 10773 high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Change From Baseline
Time Frame: Baseline and 24 weeks

Change from baseline in HbA1c after 24 weeks.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight Change From Baseline
Time Frame: Baseline and 24 weeks

Body weight change from baseline after 24 weeks.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Baseline and 24 weeks
Mean Daily Plasma Glucose (MDG) Change From Baseline
Time Frame: Baseline and 24 weeks

Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.

For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Baseline and 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Hypoglycaemic Adverse Events
Time Frame: From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Number of patients with confirmed hypoglycaemic events, as reported as adverse events.
From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1245.23
  • 2009-016258-41 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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