Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications (SENIOR)

April 10, 2020 updated by: Sanofi

A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

  • Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning
  • Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event
  • Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day
  • HbA1c change

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Study Type

Interventional

Enrollment (Actual)

1014

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

  • Argentina
      • Caba, Argentina, 1120
        • Investigational Site Number 032001
      • Caba, Argentina, 1405
        • Investigational Site Number 032002
      • Capital Federal, Argentina, 1180
        • Investigational Site Number 032006
      • Ciudad Autonoma De Buenos Aire, Argentina, 1206
        • Investigational Site Number 032004
      • Mar Del Plata, Argentina, 7602
        • Investigational Site Number 032003
  • Australia
      • Box Hill, Australia, 3128
        • Investigational Site Number 036002
      • Fitzroy, Australia, 3065
        • Investigational Site Number 036004
      • Geelong, Australia, 3220
        • Investigational Site Number 036001
      • Herston, Australia, 4029
        • Investigational Site Number 036003
  • Canada
      • Brampton, Canada, L6S 0C9
        • Investigational Site Number 124003
      • Burlington, Canada, L7M 4Y1
        • Investigational Site Number 124005
      • Chatham, Canada, N7L 1C1
        • Investigational Site Number 124008
      • Mirabel, Canada, J7J 2K8
        • Investigational Site Number 124010
      • Montreal, Canada, H2X 0A9
        • Investigational Site Number 124009
      • Sainte-Foy, Canada, G1W4R4
        • Investigational Site Number 124006
      • Thornhill, Canada, L4J 8L7
        • Investigational Site Number 124004
      • Toronto, Canada, M4G 3E8
        • Investigational Site Number 124002
      • Vancouver, Canada, V5Y 3W2
        • Investigational Site Number 124001
      • Vancouver, Canada, V5Z 1L8
        • Investigational Site Number 124007
  • Colombia
      • Armenia, Colombia, 630004
        • Investigational Site Number 170004
      • Barranquilla, Colombia, 80020
        • Investigational Site Number 170007
      • Bogota, Colombia, 110221
        • Investigational Site Number 170001
      • Bogota, Colombia, 111311
        • Investigational Site Number 170005
      • Manizales, Colombia, 170004
        • Investigational Site Number 170003
  • France
      • Lyon, France, 69495
        • Investigational Site Number 250004
      • Nantes Cedex 01, France, 44093
        • Investigational Site Number 250006
      • Poitiers Cedex, France, 86021
        • Investigational Site Number 250005
  • Germany
      • Dresden, Germany, 01307
        • Investigational Site Number 276004
      • Essen, Germany, 45359
        • Investigational Site Number 276003
      • München, Germany, 81925
        • Investigational Site Number 276001
      • Potsdam, Germany, 14469
        • Investigational Site Number 276005
      • Saarlouis, Germany, 66740
        • Investigational Site Number 276002
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Investigational Site Number 348004
      • Budapest, Hungary, 1036
        • Investigational Site Number 348001
      • Budapest, Hungary, 1062
        • Investigational Site Number 348005
      • Budapest, Hungary, 1062
        • Investigational Site Number 348007
      • Budapest, Hungary, 1213
        • Investigational Site Number 348003
      • Csongrád, Hungary, 6640
        • Investigational Site Number 348008
      • Debrecen, Hungary, 4031
        • Investigational Site Number 348009
      • Gyula, Hungary, 5700
        • Investigational Site Number 348002
  • Italy
      • Bologna, Italy, 40138
        • Investigational Site Number 380004
      • Chieti, Italy, 66013
        • Investigational Site Number 380005
      • Genova, Italy, 16132
        • Investigational Site Number 380003
      • Milano, Italy, 20132
        • Investigational Site Number 380001
      • Milano, Italy, 20122
        • Investigational Site Number 380002
  • Japan
      • Adachi-Ku, Japan
        • Investigational Site Number 392008
      • Atsugi-Shi, Japan
        • Investigational Site Number 392003
      • Kamakura-Shi, Japan
        • Investigational Site Number 392002
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392010
      • Sakado-Shi, Japan
        • Investigational Site Number 392004
      • Sapporo-Shi, Japan
        • Investigational Site Number 392013
      • Sendai-Shi, Japan
        • Investigational Site Number 392012
  • Korea, Republic of
      • Seoul, Korea, Republic of, 136-705
        • Investigational Site Number 410001
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site Number 410003
      • Seoul, Korea, Republic of, 110-746
        • Investigational Site Number 410005
      • Seoul, Korea, Republic of, 135-710
        • Investigational Site Number 410002
      • Wonju, Korea, Republic of, 220-701
        • Investigational Site Number 410004
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Investigational Site Number 484002
      • Cuernavaca, Mexico, 62250
        • Investigational Site Number 484004
      • Guadalajara, Mexico, 44150
        • Investigational Site Number 484001
      • Monterrey, Mexico, 64460
        • Investigational Site Number 484003
  • Peru
      • Arequipa, Peru
        • Investigational Site Number 604004
      • Ica, Peru, 056
        • Investigational Site Number 604007
      • Lima, Peru, 27
        • Investigational Site Number 604002
      • Lima, Peru, Lima 09
        • Investigational Site Number 604005
      • Lima, Peru, LIMA 14
        • Investigational Site Number 604001
      • Lima, Peru, Lima 32
        • Investigational Site Number 604006
      • Piura, Peru, 20001
        • Investigational Site Number 604003
  • Poland
      • Lublin, Poland, 20-538
        • Investigational Site Number 616005
      • Szczecin, Poland, 70-506
        • Investigational Site Number 616004
      • Warszawa, Poland, 02-507
        • Investigational Site Number 616003
      • Warszawa, Poland, 03-242
        • Investigational Site Number 616002
      • Zabrze, Poland, 41-800
        • Investigational Site Number 616001
  • Romania
      • Bacau, Romania, 600154
        • Investigational Site Number 642006
      • Bucuresti, Romania, 020042
        • Investigational Site Number 642001
      • Constanta, Romania, 900675
        • Investigational Site Number 642007
      • Oradea, Romania, 410159
        • Investigational Site Number 642004
      • Sibiu, Romania, 550371
        • Investigational Site Number 642005
      • Targu Mures, Romania, 540142
        • Investigational Site Number 642002
      • Targu Mures, Romania, 540142
        • Investigational Site Number 642003
  • Spain
      • Alzira, Spain, 46600
        • Investigational Site Number 724004
      • Badalona, Spain, 08916
        • Investigational Site Number 724001
      • El Ferrol, Spain, 15405
        • Investigational Site Number 724002
      • La Coruña, Spain, 15006
        • Investigational Site Number 724008
      • Málaga, Spain, 29010
        • Investigational Site Number 724006
      • Quart De Poblet, Spain, 46930
        • Investigational Site Number 724007
      • Sanlúcar De Barrameda, Spain, 11540
        • Investigational Site Number 724003
      • Sevilla, Spain, 41071
        • Investigational Site Number 724005
  • Sweden
      • Göteborg, Sweden, 405 45
        • Investigational Site Number 752002
      • Härnösand, Sweden, 871 82
        • Investigational Site Number 752004
      • Rättvik, Sweden, 79530
        • Investigational Site Number 752003
      • Västra Frölunda, Sweden, 421 44
        • Investigational Site Number 752001
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Investigational Site Number 826003
      • Belfast, United Kingdom, BT16 1RH
        • Investigational Site Number 826005
      • Bristol, United Kingdom, BS10 5NB
        • Investigational Site Number 826001
      • Redhill, United Kingdom, RH1 5RH
        • Investigational Site Number 826004
      • Rotherham, United Kingdom, S60 2UD
        • Investigational Site Number 826006
      • Swansea, United Kingdom, SA2 8PP
        • Investigational Site Number 826002
  • United States
    • Alabama
      • Saraland, Alabama, United States, 36571
        • Investigational Site Number 840058
    • California
      • Fresno, California, United States, 93720
        • Investigational Site Number 840019
      • Fresno, California, United States, 93722
        • Investigational Site Number 840021
      • Greenbrae, California, United States, 94904
        • Investigational Site Number 840040
      • Huntington Park, California, United States, 90255
        • Investigational Site Number 840070
      • Los Angeles, California, United States, 90057
        • Investigational Site Number 840064
      • Norwalk, California, United States, 90650
        • Investigational Site Number 840031
      • Oakland, California, United States, 94612
        • Investigational Site Number 840065
      • Orange, California, United States, 92868
        • Investigational Site Number 840050
      • Simi Valley, California, United States, 93065
        • Investigational Site Number 840036
      • Temecula, California, United States, 92591
        • Investigational Site Number 840003
      • Walnut Creek, California, United States, 94598
        • Investigational Site Number 840062
    • Colorado
      • Longmont, Colorado, United States, 80501
        • Investigational Site Number 840027
    • Florida
      • Bradenton, Florida, United States, 34208
        • Investigational Site Number 840030
      • Miami, Florida, United States, 33156
        • Investigational Site Number 840010
      • Miami, Florida, United States, 33156
        • Investigational Site Number 840035
      • New Port Richey, Florida, United States, 34652
        • Investigational Site Number 840014
      • Ocoee, Florida, United States, 34761
        • Investigational Site Number 840051
      • Palm Harbor, Florida, United States, 34684
        • Investigational Site Number 840056
      • Saint Petersburg, Florida, United States
        • Investigational Site Number 840007
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Investigational Site Number 840041
      • Statesboro, Georgia, United States, 30461
        • Investigational Site Number 840053
      • Woodstock, Georgia, United States, 30189
        • Investigational Site Number 840042
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Investigational Site Number 840005
      • Peoria, Illinois, United States, 61602
        • Investigational Site Number 840004
      • Springfield, Illinois, United States, 62704
        • Investigational Site Number 840029
    • Indiana
      • Avon, Indiana, United States, 46123
        • Investigational Site Number 840013
      • Avon, Indiana, United States, 46123
        • Investigational Site Number 840023
      • Evansville, Indiana, United States, 47714
        • Investigational Site Number 840039
      • Muncie, Indiana, United States, 47304
        • Investigational Site Number 840006
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Investigational Site Number 840026
      • West Des Moines, Iowa, United States, 50266
        • Investigational Site Number 840033
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Investigational Site Number 840032
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Investigational Site Number 840069
    • Michigan
      • Flint, Michigan, United States, 48504
        • Investigational Site Number 840020
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Investigational Site Number 840037
    • New York
      • New York, New York, United States, 10001
        • Investigational Site Number 840018
    • North Carolina
      • Asheville, North Carolina, United States, 28805
        • Investigational Site Number 840048
      • Charlotte, North Carolina, United States, 28209
        • Investigational Site Number 840009
      • Greensboro, North Carolina, United States, 27408
        • Investigational Site Number 840011
      • Greenville, North Carolina, United States, 27834
        • Investigational Site Number 840047
      • Salisbury, North Carolina, United States, 28144
        • Investigational Site Number 840016
      • Wilmington, North Carolina, United States, 28401
        • Investigational Site Number 840012
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Investigational Site Number 840022
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Investigational Site Number 840072
      • Wadsworth, Ohio, United States, 44281
        • Investigational Site Number 840054
    • Oregon
      • Bend, Oregon, United States, 97702
        • Investigational Site Number 840067
      • Corvallis, Oregon, United States, 97330
        • Investigational Site Number 840057
    • Pennsylvania
      • Feasterville, Pennsylvania, United States, 19053
        • Investigational Site Number 840045
      • Pittsburgh, Pennsylvania, United States, 15220
        • Investigational Site Number 840017
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Investigational Site Number 840059
      • Greer, South Carolina, United States, 29651
        • Investigational Site Number 840015
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 840002
      • Chattanooga, Tennessee, United States, 37404
        • Investigational Site Number 840046
      • Knoxville, Tennessee, United States, 37912
        • Investigational Site Number 840034
    • Texas
      • Arlington, Texas, United States, 76014
        • Investigational Site Number 840055
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 840001
      • Irving, Texas, United States, 75039
        • Investigational Site Number 840024
      • North Richland Hills, Texas, United States, 76180
        • Investigational Site Number 840061
      • Richmond, Texas, United States, 77469
        • Investigational Site Number 840028
      • San Antonio, Texas, United States, 78230
        • Investigational Site Number 840063
    • Utah
      • Saint George, Utah, United States, 84790
        • Investigational Site Number 840038
    • Washington
      • Federal Way, Washington, United States, 98003
        • Investigational Site Number 840025
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Investigational Site Number 840060

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
  • Signed informed consent.

Exclusion criteria:

  • HbA1c at screening visit:

    • <7.0% or >10.0% for participants taking basal insulin.
    • <7.5% or >11.0% for insulin-naïve participants.
  • History of type 2 diabetes mellitus for less than 1 year before screening.
  • Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
  • Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
  • Chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
  • Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score <24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score <24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
  • Participants who had end-stage renal disease (<15 mL/min/1.73m^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HOE901-U300
HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Drug: Insulin Glargine (HOE901 - U300)
Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
Other Names:
  • Toujeo®
Drug: Background therapy
Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
ACTIVE_COMPARATOR: Lantus
Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Drug: Background therapy
Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
Drug: Insulin Glargine (HOE901 - U100)
Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
Other Names:
  • Lantus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period
Time Frame: Baseline up to Week 26
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Baseline up to Week 26
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period
Time Frame: Baseline up to Week 26
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Baseline up to Week 26
Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period
Time Frame: Baseline up to Week 26
Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Baseline up to Week 26
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
Time Frame: Baseline up to Week 26
Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
Baseline up to Week 26
Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
Time Frame: Baseline up to Week 26
Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).
Baseline up to Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time Frame: Baseline, Week 26
Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
Baseline, Week 26
Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26
Time Frame: Baseline, Week 26
WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).
Baseline, Week 26
Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
Time Frame: Baseline up to Week 26
Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.
Baseline up to Week 26

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment
Time Frame: Baseline up to Week 26
Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Baseline up to Week 26
Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment
Time Frame: Baseline up to Week 26
Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Baseline up to Week 26

Collaborators and Investigators

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

Sponsor

Sanofi

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

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

January 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (ESTIMATE)

December 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC13799
  • 2014-002399-10
  • U1111-1159-3018 (OTHER: UTN)

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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