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A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT02451137
Collaborator
(none)
3,304
Enrollment
427
Locations
2
Arms
37.8
Actual Duration (Months)
7.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (<8% if age >=65 years or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic (Blood Glucose <=70 mg/deciliter [mg/dL]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting.

Secondary Objectives:

Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of:

  • Participant persistence with assigned basal insulin therapy.

  • Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia.

  • Changes in HbA1c, fasting plasma glucose, body weight

  • Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES).

  • Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin glargine, 300 U/ml
  • Drug: Insulin glargine, 100 U/ml
  • Drug: Insulin detemir
  • Drug: Background Therapy
 Phase 4

Detailed Description

The total study duration per patient will be up to 53 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension period.

Study Design

Study Type:
Interventional
Actual Enrollment :
3304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus
Actual Study Start Date :
Jun 16, 2015
Actual Primary Completion Date :
Mar 2, 2018
Actual Study Completion Date :
Aug 9, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Toujeo

Toujeo® (Insulin glargine, 300 units per millilitre [U/mL]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program.

Drug: Insulin glargine, 300 U/ml
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
  • Toujeo

    • Drug: Background Therapy
    Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.
    Active Comparator: Standard of Care

    Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (Insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.

    Drug: Insulin glargine, 100 U/ml
    Pharmaceutical form: solution Route of administration: subcutaneous
    Other Names:
  • Lantus

    • Drug: Insulin detemir
    Pharmaceutical form: solution Route of administration: subcutaneous
    Other Names:
  • Levemir

    • Drug: Background Therapy
    Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia [Baseline to Month 6]

      HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier).

    Secondary Outcome Measures

    1. Change From Baseline in HbA1c at Month 6 and Month 12 [Baseline, Month 6, Month 12]

      Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction.

    2. Treatment Persistence Measured by Medication Possession Ratio (MPR) [At Month 6 and Month 12]

      Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period.

    3. Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period [Baseline to Month 6]

      HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L).

    4. Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period [Baseline to Month 12]

      HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL).

    5. Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 [Baseline, Month 6, Month 12]

      Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction.

    6. Change From Baseline in Body Weight at Month 6 and Month 12 [Baseline, Month 6, Month 12]

      Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction.

    7. Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 [Baseline, Month 6, Month 12]

      Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.

    8. Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 [At Month 6, Month 12]

      Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported "excellent" or "good" on the GES at Month 6 and Month 12 are reported here.

    9. Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 [At Baseline, Month 6, Month 12]

      DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome.

    10. Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 [At Month 12]

      DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).

    11. Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 [From Baseline to Month 6 and Month 12]

      Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.

    12. Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period [Up to Month 6 and Month 12]

      Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :

    • Participants with Type 2 Diabetes Mellitus (T2DM), as defined by the American Diabetes Association/World Health Organization, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled after at least 1 year of treatment with 2 or more of the following: oral agents (metformin, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP4) inhibitors, or sodium-glucose cotransporter 2 (SGLT2) inhibitors) or glucagon-like peptide-1 (GLP-1) receptor agonists approved for daily use with insulin (Victoza, Byetta, Adlyxin).

    • Adult patients who have signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

    Exclusion criteria:

    • HbA1c <8.0% or >11.0%.

    • Males or females <18 years of age.

    • Type 1 diabetes mellitus.

    • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the participant's successful participation for the duration of the study.

    • Use of any product containing insulin (Lantus, Levemir, Humulin, Novolin, Humalog, Novolog, Apidra, or Afrezza) since the time of diagnosis with T2DM other than temporary use during pregnancy or hospitalization, or short-term use during acute event.

    • Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists for weekly use, or any investigational agent (drug, biologic, or device) within 3 months prior to the time of screening.

    • All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.

    • Pregnancy or lactation.

    • Women of childbearing potential with no effective contraceptive method.

    The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840731 Birmingham Alabama United States 35205
    2 Investigational Site Number 840305 Birmingham Alabama United States 35211
    3 Investigational Site Number 840811 Birmingham Alabama United States 35235
    4 Investigational Site Number 840218 Gulf Shores Alabama United States 36542
    5 Investigational Site Number 840739 Guntersville Alabama United States 35976
    6 Investigational Site Number 840367 Huntsville Alabama United States 35801
    7 Investigational Site Number 840130 Montgomery Alabama United States 36104
    8 Investigational Site Number 840729 Montgomery Alabama United States 36109
    9 Investigational Site Number 840281 Saraland Alabama United States 36571
    10 Investigational Site Number 840613 Sheffield Alabama United States 35660
    11 Investigational Site Number 840634 Sheffield Alabama United States 35660
    12 Investigational Site Number 840654 Sheffield Alabama United States 35660
    13 Investigational Site Number 840173 Phoenix Arizona United States 85032
    14 Investigational Site Number 840555 Phoenix Arizona United States 85037
    15 Investigational Site Number 840805 Sun City Arizona United States 85351
    16 Investigational Site Number 840725 Conway Arkansas United States 72034
    17 Investigational Site Number 840790 Jonesboro Arkansas United States 72401
    18 Investigational Site Number 840699 Little Rock Arkansas United States 72204
    19 Investigational Site Number 840528 Little Rock Arkansas United States 72205
    20 Investigational Site Number 840079 Searcy Arkansas United States 72143
    21 Investigational Site Number 840337 Bakersfield California United States 93304
    22 Investigational Site Number 840089 El Cajon California United States 92020
    23 Investigational Site Number 840024 Escondido California United States 92025
    24 Investigational Site Number 840020 Fresno California United States 93721
    25 Investigational Site Number 840470 Imperial California United States 92251
    26 Investigational Site Number 840155 Inglewood California United States 90301
    27 Investigational Site Number 840161 Inglewood California United States 90301
    28 Investigational Site Number 840194 Laguna Hills California United States 92653
    29 Investigational Site Number 840710 Laguna Hills California United States 92653
    30 Investigational Site Number 840204 Lancaster California United States 93534
    31 Investigational Site Number 840371 Los Angeles California United States 90017
    32 Investigational Site Number 840310 Los Angeles California United States 90036
    33 Investigational Site Number 840504 Los Angeles California United States 90036
    34 Investigational Site Number 840340 Los Angeles California United States 90057
    35 Investigational Site Number 840309 Los Gatos California United States 95032
    36 Investigational Site Number 840256 North Hollywood California United States 91606
    37 Investigational Site Number 840015 Northridge California United States 91325
    38 Investigational Site Number 840056 Norwalk California United States 90650
    39 Investigational Site Number 840090 Orange California United States 92868
    40 Investigational Site Number 840078 Palm Springs California United States 92262
    41 Investigational Site Number 840791 Palmdale California United States 93551
    42 Investigational Site Number 840216 Paramount California United States 90723
    43 Investigational Site Number 840413 Pomona California United States 91767
    44 Investigational Site Number 840244 Port Hueneme California United States 93041
    45 Investigational Site Number 840162 San Diego California United States 92111-6342
    46 Investigational Site Number 840028 San Diego California United States 92117-4961
    47 Investigational Site Number 840383 San Dimas California United States 91773
    48 Investigational Site Number 840627 San Jose California United States 95148
    49 Investigational Site Number 840120 San Ramon California United States 94583
    50 Investigational Site Number 840156 Santa Ana California United States 92704
    51 Investigational Site Number 840266 Sherman Oaks California United States 91403
    52 Investigational Site Number 840091 Sylmar California United States 91342
    53 Investigational Site Number 840208 Thousand Oaks California United States 91360
    54 Investigational Site Number 840115 Torrance California United States 90505
    55 Investigational Site Number 840792 Torrance California United States 90601
    56 Investigational Site Number 840612 Tulare California United States 93274
    57 Investigational Site Number 840467 Upland California United States 91786
    58 Investigational Site Number 840185 Vista California United States 92083
    59 Investigational Site Number 840472 Whittier California United States 90606
    60 Investigational Site Number 840411 Aurora Colorado United States 80014
    61 Investigational Site Number 840596 Denver Colorado United States 80209
    62 Investigational Site Number 840170 Denver Colorado United States 80246
    63 Investigational Site Number 840188 Englewood Colorado United States 80113
    64 Investigational Site Number 840329 Littleton Colorado United States 80127
    65 Investigational Site Number 840728 Littleton Colorado United States 80128
    66 Investigational Site Number 840687 Northglenn Colorado United States 80234
    67 Investigational Site Number 840643 Aventura Florida United States 33180
    68 Investigational Site Number 840652 Boca Raton Florida United States 33433
    69 Investigational Site Number 840449 Bradenton Florida United States 34209
    70 Investigational Site Number 840081 Cooper City Florida United States 33024
    71 Investigational Site Number 840027 Coral Gables Florida United States 33134
    72 Investigational Site Number 840446 Coral Gables Florida United States 33134
    73 Investigational Site Number 840407 Cutler Bay Florida United States 33157
    74 Investigational Site Number 840083 Doral Florida United States 33122
    75 Investigational Site Number 840141 Fleming Island Florida United States 32003
    76 Investigational Site Number 840035 Fort Lauderdale Florida United States 33316
    77 Investigational Site Number 840068 Fort Lauderdale Florida United States 33316
    78 Investigational Site Number 840145 Hialeah Florida United States 33016
    79 Investigational Site Number 840142 Jacksonville Florida United States 322078334
    80 Investigational Site Number 840352 Jacksonville Florida United States 32216
    81 Investigational Site Number 840021 Jupiter Florida United States 33458
    82 Investigational Site Number 840639 Kissimmee Florida United States 34741
    83 Investigational Site Number 840640 Kissimmee Florida United States 34741
    84 Investigational Site Number 840777 Lake Clarke Shores Florida United States 33406
    85 Investigational Site Number 840362 Margate Florida United States 33063
    86 Investigational Site Number 840221 Miami Lakes Florida United States 33016
    87 Investigational Site Number 840303 Miami Lakes Florida United States 33326
    88 Investigational Site Number 840002 Miami Florida United States 33015
    89 Investigational Site Number 840012 Miami Florida United States 33126
    90 Investigational Site Number 840698 Miami Florida United States 33126
    91 Investigational Site Number 840102 Miami Florida United States 33136
    92 Investigational Site Number 840209 Miami Florida United States 33142
    93 Investigational Site Number 840014 Miami Florida United States 33144
    94 Investigational Site Number 840128 Miami Florida United States 33155
    95 Investigational Site Number 840143 Miami Florida United States 33155
    96 Investigational Site Number 840349 Miami Florida United States 33155
    97 Investigational Site Number 840758 Miami Florida United States 33155
    98 Investigational Site Number 840690 Miami Florida United States 33166
    99 Investigational Site Number 840415 Miami Florida United States 33174
    100 Investigational Site Number 840197 Miami Florida United States 33185
    101 Investigational Site Number 840414 Miami Florida United States 33189
    102 Investigational Site Number 840508 Ocala Florida United States 34471
    103 Investigational Site Number 840092 Ocoee Florida United States 34761
    104 Investigational Site Number 840118 Palm Harbor Florida United States 34684
    105 Investigational Site Number 840080 Panama City Florida United States 32401
    106 Investigational Site Number 840372 Plantation Florida United States 33313
    107 Investigational Site Number 840199 Port Charlotte Florida United States 33952
    108 Investigational Site Number 840538 Winter Haven Florida United States 33880
    109 Investigational Site Number 840261 Atlanta Georgia United States 30328
    110 Investigational Site Number 840232 Atlanta Georgia United States 30342
    111 Investigational Site Number 840129 Blue Ridge Georgia United States 30513
    112 Investigational Site Number 840820 Columbus Georgia United States 31904
    113 Investigational Site Number 840767 Decatur Georgia United States 30034
    114 Investigational Site Number 840812 Decatur Georgia United States 30035
    115 Investigational Site Number 840700 Dunwoody Georgia United States 30338
    116 Investigational Site Number 840648 East Point Georgia United States 30344
    117 Investigational Site Number 840110 Lawrenceville Georgia United States
    118 Investigational Site Number 840444 Macon Georgia United States 31210
    119 Investigational Site Number 840003 Marietta Georgia United States 30067
    120 Investigational Site Number 840632 Sandersville Georgia United States 31082
    121 Investigational Site Number 840616 Savannah Georgia United States 31404
    122 Investigational Site Number 840591 Savannah Georgia United States 31406
    123 Investigational Site Number 840727 Smyrna Georgia United States 30082
    124 Investigational Site Number 840520 Snellville Georgia United States 30078
    125 Investigational Site Number 840163 Statesboro Georgia United States 30461
    126 Investigational Site Number 840297 Stockbridge Georgia United States 30281
    127 Investigational Site Number 840715 Thomson Georgia United States 30824
    128 Investigational Site Number 840400 Blackfoot Idaho United States 83221
    129 Investigational Site Number 840764 Boise Idaho United States 83642
    130 Investigational Site Number 840005 Chicago Illinois United States 60607
    131 Investigational Site Number 840399 Chicago Illinois United States 60607
    132 Investigational Site Number 840301 Elgin Illinois United States 60124
    133 Investigational Site Number 840402 Joliet Illinois United States 60435
    134 Investigational Site Number 840226 Morton Illinois United States 61550
    135 Investigational Site Number 840318 Peoria Illinois United States 61602
    136 Investigational Site Number 840125 Avon Indiana United States 46123
    137 Investigational Site Number 840344 Brownsburg Indiana United States 46112
    138 Investigational Site Number 840007 Evansville Indiana United States 47714
    139 Investigational Site Number 840164 Evansville Indiana United States 47714
    140 Investigational Site Number 840324 Evansville Indiana United States 47715
    141 Investigational Site Number 840022 Franklin Indiana United States 46131
    142 Investigational Site Number 840536 Greenfield Indiana United States 46140
    143 Investigational Site Number 840582 Indianapolis Indiana United States 46254
    144 Investigational Site Number 840694 Michigan City Indiana United States 46360
    145 Investigational Site Number 840052 Muncie Indiana United States 47304
    146 Investigational Site Number 840786 New Albany Indiana United States 47150
    147 Investigational Site Number 840686 Council Bluffs Iowa United States 51501
    148 Investigational Site Number 840175 Des Moines Iowa United States 50134
    149 Investigational Site Number 840466 West Des Moines Iowa United States 50266
    150 Investigational Site Number 840134 Topeka Kansas United States 66606
    151 Investigational Site Number 840801 Ashland Kentucky United States 41101
    152 Investigational Site Number 840754 Benton Kentucky United States 42025
    153 Investigational Site Number 840342 Covington Kentucky United States 41011
    154 Investigational Site Number 840713 Elizabethtown Kentucky United States 42701
    155 Investigational Site Number 840681 Hopkinsville Kentucky United States 42240
    156 Investigational Site Number 840578 Louisville Kentucky United States 40202
    157 Investigational Site Number 840478 Owensboro Kentucky United States 42303
    158 Investigational Site Number 840576 Owensboro Kentucky United States 42303
    159 Investigational Site Number 840819 Owensboro Kentucky United States 42320
    160 Investigational Site Number 840645 Paris Kentucky United States 40361
    161 Investigational Site Number 840741 Versailles Kentucky United States 40383
    162 Investigational Site Number 840592 Covington Louisiana United States 70433
    163 Investigational Site Number 840744 Covington Louisiana United States 70433
    164 Investigational Site Number 840532 Crowley Louisiana United States 70526
    165 Investigational Site Number 840760 Hammond Louisiana United States 70403
    166 Investigational Site Number 840463 Lake Charles Louisiana United States 70601
    167 Investigational Site Number 840675 Marrero Louisiana United States 70072
    168 Investigational Site Number 840133 Metairie Louisiana United States 70006
    169 Investigational Site Number 840622 Monroe Louisiana United States 71203
    170 Investigational Site Number 840147 Natchitoches Louisiana United States 71457
    171 Investigational Site Number 840609 New Orleans Louisiana United States 70115
    172 Investigational Site Number 840311 Shreveport Louisiana United States 71105
    173 Investigational Site Number 840619 Slidell Louisiana United States 70458
    174 Investigational Site Number 840673 Zachary Louisiana United States 70791
    175 Investigational Site Number 840387 Bangor Maine United States 04401
    176 Investigational Site Number 840689 Portland Maine United States 04101
    177 Investigational Site Number 840534 Baltimore Maryland United States 21218
    178 Investigational Site Number 840455 Catonsville Maryland United States 21228
    179 Investigational Site Number 840393 Rockville Maryland United States 20852
    180 Investigational Site Number 840423 Boston Massachusetts United States 02115
    181 Investigational Site Number 840117 Alpena Michigan United States 49707
    182 Investigational Site Number 840289 Detroit Michigan United States 48235
    183 Investigational Site Number 840053 Essexville Michigan United States 48732
    184 Investigational Site Number 840150 Flint Michigan United States 48504
    185 Investigational Site Number 840184 Flint Michigan United States 48532
    186 Investigational Site Number 840236 Kalamazoo Michigan United States 49009
    187 Investigational Site Number 840210 Southfield Michigan United States
    188 Investigational Site Number 840258 Stevensville Michigan United States 49127
    189 Investigational Site Number 840158 Troy Michigan United States 48085
    190 Investigational Site Number 840524 Troy Michigan United States 48098
    191 Investigational Site Number 840033 Olive Branch Mississippi United States 38654
    192 Investigational Site Number 840302 Bridgeton Missouri United States 63044
    193 Investigational Site Number 840693 Chesterfield Missouri United States 63017
    194 Investigational Site Number 840041 Jefferson City Missouri United States 65109
    195 Investigational Site Number 840711 Saint Louis Missouri United States 63128
    196 Investigational Site Number 840753 Billings Montana United States 59102
    197 Investigational Site Number 840603 Butte Montana United States 59701
    198 Investigational Site Number 840264 Elkhorn Nebraska United States 68022
    199 Investigational Site Number 840742 Omaha Nebraska United States 68144
    200 Investigational Site Number 840294 Henderson Nevada United States 89014
    201 Investigational Site Number 840087 Henderson Nevada United States 89052
    202 Investigational Site Number 840664 Las Vegas Nevada United States 89101
    203 Investigational Site Number 840108 Las Vegas Nevada United States 89106
    204 Investigational Site Number 840412 Las Vegas Nevada United States 89109
    205 Investigational Site Number 840656 Las Vegas Nevada United States 89117
    206 Investigational Site Number 840638 Las Vegas Nevada United States 89118
    207 Investigational Site Number 840750 Las Vegas Nevada United States 89121
    208 Investigational Site Number 840815 Las Vegas Nevada United States 89144
    209 Investigational Site Number 840761 Reno Nevada United States 89511
    210 Investigational Site Number 840144 Nashua New Hampshire United States 03063-4068
    211 Investigational Site Number 840799 Edison New Jersey United States 08837
    212 Investigational Site Number 840167 Linden New Jersey United States 07036
    213 Investigational Site Number 840060 Neptune New Jersey United States 07753
    214 Investigational Site Number 840679 Sicklerville New Jersey United States 08081
    215 Investigational Site Number 840559 Teaneck New Jersey United States 07666
    216 Investigational Site Number 840481 Albany New York United States 12206
    217 Investigational Site Number 840772 Amityville New York United States 11701
    218 Investigational Site Number 840746 Babylon New York United States 11702
    219 Investigational Site Number 840355 Brooklyn New York United States 11215
    220 Investigational Site Number 840136 Brooklyn New York United States
    221 Investigational Site Number 840734 Forest Hills New York United States 11375
    222 Investigational Site Number 840659 Great Neck New York United States 11367
    223 Investigational Site Number 840644 Holbrook New York United States 11741
    224 Investigational Site Number 840159 Jamaica New York United States 11432
    225 Investigational Site Number 840148 Lake Success New York United States 11042
    226 Investigational Site Number 840253 Laurelton New York United States 11422
    227 Investigational Site Number 840789 Merrick New York United States 11566
    228 Investigational Site Number 840716 Nesconset New York United States 11767
    229 Investigational Site Number 840810 New Hyde Park New York United States 11040
    230 Investigational Site Number 840072 New Hyde Park New York United States 11042
    231 Investigational Site Number 840674 New Windsor New York United States 12553
    232 Investigational Site Number 840626 New York New York United States 10001
    233 Investigational Site Number 840586 New York New York United States 10128
    234 Investigational Site Number 840044 North Massapequa New York United States 11758-1802
    235 Investigational Site Number 840587 Smithtown New York United States 11787
    236 Investigational Site Number 840577 Staten Island New York United States 10301-3914
    237 Investigational Site Number 840773 Syosset New York United States 11791
    238 Investigational Site Number 840047 Yonkers New York United States 10704
    239 Investigational Site Number 840214 Asheville North Carolina United States 28803
    240 Investigational Site Number 840237 Burlington North Carolina United States 27215
    241 Investigational Site Number 840714 Burlington North Carolina United States 27215
    242 Investigational Site Number 840456 Charlotte North Carolina United States 28204
    243 Investigational Site Number 840312 Concord North Carolina United States 28025
    244 Investigational Site Number 840763 Greensboro North Carolina United States 27401
    245 Investigational Site Number 840611 Greensboro North Carolina United States 27405
    246 Investigational Site Number 840776 Greensboro North Carolina United States 27408
    247 Investigational Site Number 840361 Greenville North Carolina United States 27834
    248 Investigational Site Number 840705 High Point North Carolina United States 27262
    249 Investigational Site Number 840755 Lexington North Carolina United States 27292
    250 Investigational Site Number 840688 Mooresville North Carolina United States 28117
    251 Investigational Site Number 840747 Mooresville North Carolina United States 28117
    252 Investigational Site Number 840296 Morganton North Carolina United States 28655
    253 Investigational Site Number 840573 New Bern North Carolina United States 28562
    254 Investigational Site Number 840096 Salisbury North Carolina United States 28144
    255 Investigational Site Number 840697 Shelby North Carolina United States 28150
    256 Investigational Site Number 840636 Wilmington North Carolina United States 28401
    257 Investigational Site Number 840195 Wilson North Carolina United States 27893
    258 Investigational Site Number 840315 Winston-Salem North Carolina United States 27103
    259 Investigational Site Number 840545 Fargo North Dakota United States 58104
    260 Investigational Site Number 840077 Canal Fulton Ohio United States 44614
    261 Investigational Site Number 840738 Canton Ohio United States 44718
    262 Investigational Site Number 840064 Cincinnati Ohio United States 45212
    263 Investigational Site Number 840701 Cincinnati Ohio United States 45242
    264 Investigational Site Number 840779 Cleveland Ohio United States 44113
    265 Investigational Site Number 840380 Columbus Ohio United States 43201
    266 Investigational Site Number 840339 Columbus Ohio United States 43203
    267 Investigational Site Number 840063 Columbus Ohio United States 43207
    268 Investigational Site Number 840191 Columbus Ohio United States 43207
    269 Investigational Site Number 840752 Columbus Ohio United States 43213
    270 Investigational Site Number 840684 Elyria Ohio United States 44035
    271 Investigational Site Number 840663 Findlay Ohio United States 45840
    272 Investigational Site Number 840379 Franklin Ohio United States 45005
    273 Investigational Site Number 840126 Gallipolis Ohio United States 45631
    274 Investigational Site Number 840771 Kettering Ohio United States 45429
    275 Investigational Site Number 840257 Lancaster Ohio United States 43130
    276 Investigational Site Number 840584 Lyndhurst Ohio United States 44124
    277 Investigational Site Number 840165 Marion Ohio United States 43302
    278 Investigational Site Number 840800 Miamisburg Ohio United States 45342
    279 Investigational Site Number 840560 Tallmadge Ohio United States 44278
    280 Investigational Site Number 840515 Toledo Ohio United States 43623
    281 Investigational Site Number 840797 Vandalia Ohio United States 45377
    282 Investigational Site Number 840192 Wadsworth Ohio United States 44201
    283 Investigational Site Number 840389 Willoughby Hills Ohio United States 44094
    284 Investigational Site Number 840751 Wooster Ohio United States 44691
    285 Investigational Site Number 840262 Edmond Oklahoma United States 73034
    286 Investigational Site Number 840360 Midwest City Oklahoma United States 73110
    287 Investigational Site Number 840363 Oklahoma City Oklahoma United States 73104
    288 Investigational Site Number 840556 Oklahoma City Oklahoma United States 73112
    289 Investigational Site Number 840103 Bend Oregon United States 97702
    290 Investigational Site Number 840292 Altoona Pennsylvania United States 16602
    291 Investigational Site Number 840009 Beaver Pennsylvania United States 15009
    292 Investigational Site Number 840059 Downingtown Pennsylvania United States 19335
    293 Investigational Site Number 840181 Fleetwood Pennsylvania United States 19522
    294 Investigational Site Number 840743 Greensburg Pennsylvania United States 15601
    295 Investigational Site Number 840479 Huntingdon Valley Pennsylvania United States 19006
    296 Investigational Site Number 840712 Indiana Pennsylvania United States 15701
    297 Investigational Site Number 840523 Lansdale Pennsylvania United States 19446
    298 Investigational Site Number 840766 Levittown Pennsylvania United States 19056
    299 Investigational Site Number 840032 Penndel Pennsylvania United States 19047
    300 Investigational Site Number 840067 Philadelphia Pennsylvania United States 19102
    301 Investigational Site Number 840277 Philadelphia Pennsylvania United States 19107
    302 Investigational Site Number 840561 Philadelphia Pennsylvania United States 19114
    303 Investigational Site Number 840174 Philadelphia Pennsylvania United States 19146
    304 Investigational Site Number 840348 Pittsburgh Pennsylvania United States 15243
    305 Investigational Site Number 840669 Pottstown Pennsylvania United States 19464
    306 Investigational Site Number 840748 Sayre Pennsylvania United States 18840
    307 Investigational Site Number 840187 Smithfield Pennsylvania United States 15478
    308 Investigational Site Number 840287 Uniontown Pennsylvania United States 15401
    309 Investigational Site Number 840341 Uniontown Pennsylvania United States 15401
    310 Investigational Site Number 840378 Providence Rhode Island United States 02908
    311 Investigational Site Number 840491 Anderson South Carolina United States 29621
    312 Investigational Site Number 840732 Greenville South Carolina United States 29601
    313 Investigational Site Number 840043 Greer South Carolina United States 29651
    314 Investigational Site Number 840109 Murrells Inlet South Carolina United States 29576
    315 Investigational Site Number 840327 North Myrtle Beach South Carolina United States 29582
    316 Investigational Site Number 840759 Simpsonville South Carolina United States 29681
    317 Investigational Site Number 840628 Summerville South Carolina United States 29485
    318 Investigational Site Number 840717 Bristol Tennessee United States 37620
    319 Investigational Site Number 840160 Chattanooga Tennessee United States 37404
    320 Investigational Site Number 840794 Franklin Tennessee United States 37064
    321 Investigational Site Number 840171 Jackson Tennessee United States 38305
    322 Investigational Site Number 840550 Jackson Tennessee United States 38305
    323 Investigational Site Number 840132 Kingsport Tennessee United States 37660
    324 Investigational Site Number 840140 Knoxville Tennessee United States 37912
    325 Investigational Site Number 840625 Memphis Tennessee United States 38119
    326 Investigational Site Number 840299 Nashville Tennessee United States 37203
    327 Investigational Site Number 840381 New Tazewell Tennessee United States 37825
    328 Investigational Site Number 840213 Amarillo Texas United States 79106
    329 Investigational Site Number 840157 Corpus Christi Texas United States 78404
    330 Investigational Site Number 840011 Dallas Texas United States 75218
    331 Investigational Site Number 840313 Dallas Texas United States 75218
    332 Investigational Site Number 840013 Dallas Texas United States 75231
    333 Investigational Site Number 840034 Dallas Texas United States 75231
    334 Investigational Site Number 840333 Dallas Texas United States 75235
    335 Investigational Site Number 840405 Dallas Texas United States 75254
    336 Investigational Site Number 840330 El Paso Texas United States 79925
    337 Investigational Site Number 840307 Fort Worth Texas United States 76104
    338 Investigational Site Number 840182 Houston Texas United States 77008
    339 Investigational Site Number 840366 Houston Texas United States 77024
    340 Investigational Site Number 840608 Houston Texas United States 77043
    341 Investigational Site Number 840323 Houston Texas United States 77053
    342 Investigational Site Number 840502 Houston Texas United States 77070
    343 Investigational Site Number 840513 Houston Texas United States 77070
    344 Investigational Site Number 840377 Houston Texas United States 77079
    345 Investigational Site Number 840306 Houston Texas United States 77083-4436
    346 Investigational Site Number 840137 Houston Texas United States 77090
    347 Investigational Site Number 840521 Houston Texas United States 77090
    348 Investigational Site Number 840533 Houston Texas United States 77095
    349 Investigational Site Number 840211 Houston Texas United States 77099
    350 Investigational Site Number 840260 Humble Texas United States 77338
    351 Investigational Site Number 840403 Irving Texas United States 75039
    352 Investigational Site Number 840382 Lampasas Texas United States 76550
    353 Investigational Site Number 840680 Lubbock Texas United States 79423
    354 Investigational Site Number 840308 McAllen Texas United States 78503
    355 Investigational Site Number 840549 Mesquite Texas United States 75149
    356 Investigational Site Number 840351 Missouri City Texas United States 77459
    357 Investigational Site Number 840373 Palestine Texas United States 75801
    358 Investigational Site Number 840365 Pharr Texas United States 78577
    359 Investigational Site Number 840439 Plano Texas United States 75093
    360 Investigational Site Number 840707 Port Arthur Texas United States 77640
    361 Investigational Site Number 840692 Richmond Texas United States 77469
    362 Investigational Site Number 840431 San Antonio Texas United States 78215
    363 Investigational Site Number 840074 San Antonio Texas United States 78218
    364 Investigational Site Number 840691 San Antonio Texas United States 78221
    365 Investigational Site Number 840176 San Antonio Texas United States 78228
    366 Investigational Site Number 840135 San Antonio Texas United States 78229-3901
    367 Investigational Site Number 840018 San Antonio Texas United States 78229
    368 Investigational Site Number 840434 San Antonio Texas United States 78229
    369 Investigational Site Number 840390 San Antonio Texas United States 78249
    370 Investigational Site Number 840207 Schertz Texas United States 78154
    371 Investigational Site Number 840615 Sealy Texas United States 77474
    372 Investigational Site Number 840097 Sugar Land Texas United States 77478
    373 Investigational Site Number 840460 Sugar Land Texas United States 77478
    374 Investigational Site Number 840514 Sugar Land Texas United States 77478
    375 Investigational Site Number 840530 Sugar Land Texas United States 77479
    376 Investigational Site Number 840008 Waco Texas United States 76710
    377 Investigational Site Number 840593 Waco Texas United States 76712
    378 Investigational Site Number 840809 Waxahachie Texas United States 75165
    379 Investigational Site Number 840651 Webster Texas United States 77598
    380 Investigational Site Number 840392 Clinton Utah United States 84015
    381 Investigational Site Number 840189 Saint George Utah United States 84790
    382 Investigational Site Number 840228 Salt Lake City Utah United States 84107
    383 Investigational Site Number 840765 West Jordan Utah United States 84088
    384 Investigational Site Number 840806 West Jordan Utah United States 84088
    385 Investigational Site Number 840580 Chatham Virginia United States 24541
    386 Investigational Site Number 840590 Chesapeake Virginia United States 23321
    387 Investigational Site Number 840788 Danville Virginia United States 24540
    388 Investigational Site Number 840706 Danville Virginia United States 24541
    389 Investigational Site Number 840736 Danville Virginia United States 24541
    390 Investigational Site Number 840575 Fredericksburg Virginia United States 22408
    391 Investigational Site Number 840662 Hampton Virginia United States 23666
    392 Investigational Site Number 840795 Lynchburg Virginia United States 24501
    393 Investigational Site Number 840605 Martinsville Virginia United States 24112
    394 Investigational Site Number 840620 Newport News Virginia United States 23606
    395 Investigational Site Number 840088 Norfolk Virginia United States
    396 Investigational Site Number 840247 North Chesterfield Virginia United States 11042
    397 Investigational Site Number 840730 Pennington Gap Virginia United States 24277
    398 Investigational Site Number 840179 Richmond Virginia United States 23219
    399 Investigational Site Number 840076 Salem Virginia United States
    400 Investigational Site Number 840354 Virginia Beach Virginia United States 23462
    401 Investigational Site Number 840704 Winchester Virginia United States 22601
    402 Investigational Site Number 840709 Everett Washington United States 98208
    403 Investigational Site Number 840238 Federal Way Washington United States 98003-8708
    404 Investigational Site Number 840588 Vancouver Washington United States 98664
    405 Investigational Site Number 840084 Walla Walla Washington United States 99362
    406 Investigational Site Number 840658 Charleston West Virginia United States 25304
    407 Investigational Site Number 840595 Lewisburg West Virginia United States 24901
    408 Investigational Site Number 124002 Barrie Canada L4N4L3
    409 Investigational Site Number 124005 Brampton Canada L6S0C9
    410 Investigational Site Number 124001 Brampton Canada L6T4V3
    411 Investigational Site Number 124030 Burlington Canada L7R1A4
    412 Investigational Site Number 124017 Calgary Canada T2H2G4
    413 Investigational Site Number 124013 Concord Canada L4K4M2
    414 Investigational Site Number 124018 Etobicoke Canada M9R4E1
    415 Investigational Site Number 124014 Etobicoke Canada M9V4V4
    416 Investigational Site Number 124026 Guelph Canada N1H1B1
    417 Investigational Site Number 124008 Hamilton Canada L8K3P3
    418 Investigational Site Number 124027 Hamilton Canada L8L5G8
    419 Investigational Site Number 124010 London Canada N5W 6A2
    420 Investigational Site Number 124015 Markham Canada L6B0P9
    421 Investigational Site Number 124020 Montreal Canada H2R1V6
    422 Investigational Site Number 124016 Newmarket Canada
    423 Investigational Site Number 124024 Oakville Canada L6M1M1
    424 Investigational Site Number 124029 Saint-Laurent Canada H4T1Z9
    425 Investigational Site Number 124007 Surrey Canada V4A1R6
    426 Investigational Site Number 124003 Toronto Canada M4G3E8
    427 Investigational Site Number 124025 Vancouver Canada V5X0C4

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT02451137
    Other Study ID Numbers:
    • LPS14347
    • U1111-1168-0354
    First Posted:
    May 21, 2015
    Last Update Posted:
    Sep 10, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Insulin
    Insulin, Globin Zinc
    Insulin Glargine
    Insulin Detemir

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 427 sites in 2 countries. A total of 4989 participants were screened between 16 June 2015 and 14 July 2017, of which 1684 were screen failures. Screen failures were mainly due to inclusion criteria not met.
    Pre-assignment Detail Out of 3305 participants, 1 participant was not randomized, but received treatment; hence not included in any analysis (baseline, efficacy and safety). Assignment in arms was done centrally by interactive response technology (IRT) in 1:1 ratio.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 units per millilitre [U/mL]) subcutaneous (SC) injection administered once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Period Title: Overall Study
    STARTED 1651 1653
    Treated 1632 1626
    Safety Population 1637 1621
    COMPLETED 1405 1355
    NOT COMPLETED 246 298

    Baseline Characteristics

    Arm/Group Title Toujeo Standard of Care Total
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program. Total of all reporting groups
    Overall Participants 1651 1653 3304
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    59.4
    (10.8)
    59.1
    (11.0)
    59.3
    (10.9)
    Sex: Female, Male (Count of Participants)
    Female
    747
    45.2%
    731
    44.2%
    1478
    44.7%
    Male
    904
    54.8%
    922
    55.8%
    1826
    55.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    286
    17.3%
    305
    18.5%
    591
    17.9%
    Not Hispanic or Latino
    1365
    82.7%
    1348
    81.5%
    2713
    82.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian/White
    1283
    77.7%
    1299
    78.6%
    2582
    78.1%
    Black
    262
    15.9%
    238
    14.4%
    500
    15.1%
    Asian/Oriental
    83
    5%
    95
    5.7%
    178
    5.4%
    American Indian or Alaska Native
    15
    0.9%
    12
    0.7%
    27
    0.8%
    Native Hawaiian or other Pacific Islander
    6
    0.4%
    4
    0.2%
    10
    0.3%
    Other
    12
    0.7%
    14
    0.8%
    26
    0.8%
    Region of Enrollment (Count of Participants)
    Canada
    82
    5%
    85
    5.1%
    167
    5.1%
    United States
    1569
    95%
    1568
    94.9%
    3137
    94.9%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    33.85
    (7.14)
    33.70
    (7.29)
    33.77
    (7.22)
    Duration of Type 2 Diabetes Mellitus (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    11.43
    (7.43)
    11.16
    (7.31)
    11.30
    (7.37)
    Baseline glycated hemoglobin (HbA1c) (percentage of HbA1c) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percentage of HbA1c]
    9.1
    (0.8)
    9.2
    (0.8)
    9.2
    (0.8)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia
    Description HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier).
    Time Frame Baseline to Month 6

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on Intent-to-Treat (ITT) population which comprised of all randomized participants, irrespective of the treatment actually received, and analyzed according to the treatment group allocated by randomization.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Number [percentage of participants]
    31.3
    1.9%
    27.9
    1.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Toujeo, Standard of Care
    Comments A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (<8%,<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0308
    Comments Threshold for significance at 0.046 level.
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.19
    Confidence Interval (2-Sided) 95.4%
    1.01 to 1.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Baseline in HbA1c at Month 6 and Month 12
    Description Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction.
    Time Frame Baseline, Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Month 6
    -1.40
    (0.030)
    -1.36
    (0.030)
    Month 12
    -1.29
    (0.034)
    -1.24
    (0.034)
    3. Secondary Outcome
    Title Treatment Persistence Measured by Medication Possession Ratio (MPR)
    Description Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period.
    Time Frame At Month 6 and Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1637 1621
    Month 6
    62.06
    (26.98)
    63.14
    (28.42)
    Month 12
    58.21
    (28.87)
    57.82
    (29.97)
    4. Secondary Outcome
    Title Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period
    Description HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L).
    Time Frame Baseline to Month 6

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Number [percentage of participants]
    37.3
    2.3%
    34.3
    2.1%
    5. Secondary Outcome
    Title Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period
    Description HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL).
    Time Frame Baseline to Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Month 12: <=70 mg/dL
    26.1
    1.6%
    23.7
    1.4%
    Month 12: <54 mg/dL
    33.0
    2%
    29.5
    1.8%
    6. Secondary Outcome
    Title Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12
    Description Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction.
    Time Frame Baseline, Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Month 6
    -48.9
    (1.56)
    -50.4
    (1.58)
    Month 12
    -48.0
    (1.66)
    -47.3
    (1.69)
    7. Secondary Outcome
    Title Change From Baseline in Body Weight at Month 6 and Month 12
    Description Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction.
    Time Frame Baseline, Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Month 6
    1.02
    (0.109)
    1.14
    (0.110)
    Month 12
    1.51
    (0.140)
    1.40
    (0.142)
    8. Secondary Outcome
    Title Change From Baseline in Basal Insulin Dose at Month 6 and Month 12
    Description Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.
    Time Frame Baseline, Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1637 1621
    Month 6
    0.179
    (0.212)
    0.183
    (0.218)
    Month 12
    0.222
    (0.232)
    0.224
    (0.241)
    9. Secondary Outcome
    Title Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12
    Description Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported "excellent" or "good" on the GES at Month 6 and Month 12 are reported here.
    Time Frame At Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Percentage of Participants: Month 6
    67.2
    65.6
    Percentage of Providers: Month 6
    62.1
    57.7
    Percentage of Participants: Month 12
    64.7
    64.2
    Percentage of Providers: Month 12
    58.8
    56.3
    10. Secondary Outcome
    Title Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12
    Description DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome.
    Time Frame At Baseline, Month 6, Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population. Here, "number analyzed" = participants with available data for each specified category.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Total treatment satisfaction score:Baseline
    26.5
    (7.0)
    26.4
    (7.1)
    Total treatment satisfaction score: Month 6
    31.0
    (5.5)
    31.1
    (5.3)
    Total treatment satisfaction score: Month 12
    30.9
    (6.0)
    30.7
    (6.1)
    Perceived frequencyof hyperglycemia score:Baseline
    4.3
    (1.7)
    4.3
    (1.7)
    Perceived frequency of hyperglycemia score:Month 6
    2.8
    (1.7)
    2.8
    (1.7)
    Perceived frequency of hyperglycemia score:Month12
    2.6
    (1.7)
    2.6
    (1.7)
    Perceived frequency of hypoglycemia score:Baseline
    0.9
    (1.4)
    0.8
    (1.3)
    Perceived frequency of hypoglycemia score: Month 6
    0.9
    (1.3)
    1.0
    (1.4)
    Perceived frequency of hypoglycemia score:Month 12
    0.9
    (1.3)
    1.0
    (1.4)
    11. Secondary Outcome
    Title Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12
    Description DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).
    Time Frame At Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population. Here, "number analyzed" = participants with available data for assessment during the 12 month randomized period.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Total satisfaction score
    13.81
    (0.15)
    13.79
    (0.15)
    Perceived frequency of hyperglycemia score
    0.14
    (0.05)
    0.21
    (0.05)
    Perceived frequency of hypoglycemia
    -0.82
    (0.05)
    -0.82
    (0.05)
    12. Secondary Outcome
    Title Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12
    Description Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.
    Time Frame From Baseline to Month 6 and Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on ITT population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1651 1653
    Hospitalizations: Month 6
    8.1
    0.5%
    7.5
    0.5%
    Emergency Room Visits: Month 6
    11.3
    0.7%
    10.3
    0.6%
    Specialty Visits: Month 6
    78.3
    4.7%
    74.0
    4.5%
    Hospitalizations: Month 12
    9.1
    0.6%
    8.0
    0.5%
    Emergency Room Visits: Month 12
    12.7
    0.8%
    11.1
    0.7%
    Specialty Visits: Month 12
    80.1
    4.9%
    75.9
    4.6%
    13. Secondary Outcome
    Title Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period
    Description Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L).
    Time Frame Up to Month 6 and Month 12

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on safety population.
    Arm/Group Title Toujeo Standard of Care
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    Measure Participants 1637 1621
    Any hypoglycemia: Any time: Month 6
    28.9
    1.8%
    30.4
    1.8%
    Any hypoglycemia: Nocturnal: Month 6
    8.9
    0.5%
    10.0
    0.6%
    Any hypoglycemia: Any time: Month 12
    39.1
    2.4%
    41.8
    2.5%
    Any hypoglycemia: Nocturnal: Month 12
    13.6
    0.8%
    14.9
    0.9%
    Severe hypoglycemia: Any time: Month 6
    1.0
    0.1%
    1.0
    0.1%
    Severe hypoglycemia:Nocturnal: Month 6
    0.5
    0%
    0.6
    0%
    Documented Symptomatic <=70 mg/dL:Any time:Month 6
    13.9
    0.8%
    14.9
    0.9%
    Documented Symptomatic <54 mg/dL:Any time:Month 6
    3.6
    0.2%
    3.1
    0.2%
    Documented Symptomatic <=70mg/dL:Nocturnal:Month 6
    4.5
    0.3%
    5.6
    0.3%
    Documented Symptomatic <54 mg/dL:Nocturnal:Month 6
    0.8
    0%
    0.8
    0%
    Severe hypoglycemia: Any time: Month 12
    1.2
    0.1%
    1.9
    0.1%
    Severe hypoglycemia:Nocturnal: Month 12
    0.5
    0%
    0.7
    0%
    Documented Symptomatic<=70 mg/dL:Any time:Month 12
    19.9
    1.2%
    20.8
    1.3%
    Documented Symptomatic <54 mg/dL:Any time:Month 12
    5.6
    0.3%
    5.6
    0.3%
    Documented Symptomatic<=70mg/dL:Nocturnal:Month 12
    6.5
    0.4%
    8.3
    0.5%
    Documented Symptomatic <54mg/dL:Nocturnal:Month 12
    1.2
    0.1%
    1.7
    0.1%

    Adverse Events

    Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the end of study (12 months) regardless of seriousness or relationship to investigational product.
    Adverse Event Reporting Description Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first injection of investigational medicinal product (IMP) up to 1 day after the last injection of IMP). Analysis was performed on safety population.
    Arm/Group Title Toujeo Standard of Care Basal Insulin
    Arm/Group Description Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Month 12, with or without available participant support program. Lantus® (Insulin glargine, 100 U/mL) SC injection administered once daily; or Levemir® (insulin detemir) SC injection administered either once or twice daily up to Month 12, with or without available participant support program.
    All Cause Mortality
    Toujeo Standard of Care Basal Insulin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/1637 (0.4%) 4/1621 (0.2%)
    Serious Adverse Events
    Toujeo Standard of Care Basal Insulin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 161/1637 (9.8%) 165/1621 (10.2%)
    Blood and lymphatic system disorders
    Anaemia 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Febrile Neutropenia 2/1637 (0.1%) 3 1/1621 (0.1%) 1
    Haemorrhagic Anaemia 3/1637 (0.2%) 3 2/1621 (0.1%) 2
    Lymphadenitis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Lymphadenopathy Mediastinal 0/1637 (0%) 0 1/1621 (0.1%) 1
    Neutropenia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Normochromic Normocytic Anaemia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Pancytopenia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Thrombocytopenia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Cardiac disorders
    Acute Left Ventricular Failure 3/1637 (0.2%) 3 2/1621 (0.1%) 2
    Acute Myocardial Infarction 8/1637 (0.5%) 8 4/1621 (0.2%) 4
    Angina Pectoris 6/1637 (0.4%) 7 3/1621 (0.2%) 3
    Angina Unstable 4/1637 (0.2%) 5 4/1621 (0.2%) 4
    Aortic Valve Stenosis 2/1637 (0.1%) 2 0/1621 (0%) 0
    Arrhythmia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Arteriosclerosis Coronary Artery 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Atrial Fibrillation 8/1637 (0.5%) 8 6/1621 (0.4%) 6
    Atrial Flutter 0/1637 (0%) 0 1/1621 (0.1%) 1
    Atrioventricular Block Complete 0/1637 (0%) 0 1/1621 (0.1%) 1
    Bradycardia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Bundle Branch Block Left 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cardiac Arrest 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cardiac Failure 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cardiac Failure Acute 4/1637 (0.2%) 4 3/1621 (0.2%) 3
    Cardiac Failure Congestive 6/1637 (0.4%) 6 4/1621 (0.2%) 4
    Coronary Artery Disease 10/1637 (0.6%) 10 9/1621 (0.6%) 9
    Coronary Artery Stenosis 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Intracardiac Thrombus 1/1637 (0.1%) 1 0/1621 (0%) 0
    Ischaemic Cardiomyopathy 2/1637 (0.1%) 2 0/1621 (0%) 0
    Myocardial Infarction 3/1637 (0.2%) 3 3/1621 (0.2%) 3
    Supraventricular Tachycardia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Ventricular Extrasystoles 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ventricular Tachycardia 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Ear and labyrinth disorders
    Vertigo 0/1637 (0%) 0 1/1621 (0.1%) 1
    Endocrine disorders
    Autoimmune Thyroiditis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Eye disorders
    Glaucoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Retinal Haemorrhage 1/1637 (0.1%) 1 0/1621 (0%) 0
    Vision Blurred 0/1637 (0%) 0 1/1621 (0.1%) 1
    Gastrointestinal disorders
    Abdominal Pain 2/1637 (0.1%) 2 2/1621 (0.1%) 2
    Ascites 1/1637 (0.1%) 1 0/1621 (0%) 0
    Colitis 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Diarrhoea 0/1637 (0%) 0 1/1621 (0.1%) 1
    Diverticulum Intestinal Haemorrhagic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Dysphagia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Gastrointestinal Haemorrhage 1/1637 (0.1%) 1 0/1621 (0%) 0
    Gastrointestinal Ulcer Haemorrhage 0/1637 (0%) 0 1/1621 (0.1%) 1
    Haematochezia 2/1637 (0.1%) 2 0/1621 (0%) 0
    Haemorrhoids 0/1637 (0%) 0 2/1621 (0.1%) 2
    Impaired Gastric Emptying 1/1637 (0.1%) 1 0/1621 (0%) 0
    Intestinal Obstruction 1/1637 (0.1%) 1 0/1621 (0%) 0
    Large Intestine Polyp 0/1637 (0%) 0 1/1621 (0.1%) 1
    Nausea 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Pancreatitis 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Pancreatitis Acute 0/1637 (0%) 0 1/1621 (0.1%) 1
    Pancreatitis Necrotising 0/1637 (0%) 0 1/1621 (0.1%) 1
    Small Intestinal Obstruction 0/1637 (0%) 0 1/1621 (0.1%) 1
    Varices Oesophageal 0/1637 (0%) 0 1/1621 (0.1%) 1
    Vomiting 0/1637 (0%) 0 2/1621 (0.1%) 2
    General disorders
    Asthenia 1/1637 (0.1%) 1 1/1621 (0.1%) 2
    Chest Pain 1/1637 (0.1%) 1 0/1621 (0%) 0
    Death 2/1637 (0.1%) 2 0/1621 (0%) 0
    Gait Disturbance 0/1637 (0%) 0 1/1621 (0.1%) 1
    Non-Cardiac Chest Pain 10/1637 (0.6%) 10 5/1621 (0.3%) 5
    Pelvic Mass 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pyrexia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Sudden Death 0/1637 (0%) 0 1/1621 (0.1%) 1
    Systemic Inflammatory Response Syndrome 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Vascular Stent Stenosis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hepatobiliary disorders
    Bile Duct Stone 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Biliary Dyskinesia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Cholangitis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Cholecystitis 0/1637 (0%) 0 2/1621 (0.1%) 2
    Cholecystitis Acute 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Cholelithiasis 3/1637 (0.2%) 3 3/1621 (0.2%) 3
    Cirrhosis Alcoholic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hepatic Steatosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Hepatomegaly 0/1637 (0%) 0 1/1621 (0.1%) 1
    Immune system disorders
    Anaphylactic Reaction 0/1637 (0%) 0 2/1621 (0.1%) 2
    Sarcoidosis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Infections and infestations
    Appendicitis 0/1637 (0%) 0 2/1621 (0.1%) 2
    Appendicitis Perforated 0/1637 (0%) 0 1/1621 (0.1%) 1
    Arthritis Bacterial 0/1637 (0%) 0 1/1621 (0.1%) 1
    Breast Abscess 0/1637 (0%) 0 1/1621 (0.1%) 1
    Breast Cellulitis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Bronchitis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Cellulitis 2/1637 (0.1%) 2 7/1621 (0.4%) 7
    Cholecystitis Infective 0/1637 (0%) 0 2/1621 (0.1%) 2
    Cystitis 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Diabetic Foot Infection 0/1637 (0%) 0 1/1621 (0.1%) 1
    Diverticulitis 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Escherichia Bacteraemia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Escherichia Sepsis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Gangrene 0/1637 (0%) 0 1/1621 (0.1%) 1
    Gastroenteritis 2/1637 (0.1%) 2 0/1621 (0%) 0
    Gastroenteritis Viral 1/1637 (0.1%) 1 0/1621 (0%) 0
    Herpes Zoster 1/1637 (0.1%) 1 0/1621 (0%) 0
    Infectious Colitis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Influenza 0/1637 (0%) 0 1/1621 (0.1%) 1
    Localised Infection 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ludwig Angina 1/1637 (0.1%) 1 0/1621 (0%) 0
    Necrotising Fasciitis 0/1637 (0%) 0 2/1621 (0.1%) 2
    Osteomyelitis 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Osteomyelitis Acute 0/1637 (0%) 0 1/1621 (0.1%) 1
    Osteomyelitis Chronic 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pneumonia 10/1637 (0.6%) 10 14/1621 (0.9%) 14
    Pneumonia Respiratory Syncytial Viral 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pseudomembranous Colitis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pyelonephritis 2/1637 (0.1%) 2 0/1621 (0%) 0
    Sepsis 4/1637 (0.2%) 4 8/1621 (0.5%) 8
    Septic Shock 1/1637 (0.1%) 1 0/1621 (0%) 0
    Skin Infection 0/1637 (0%) 0 1/1621 (0.1%) 1
    Staphylococcal Bacteraemia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Staphylococcal Skin Infection 1/1637 (0.1%) 1 0/1621 (0%) 0
    Streptococcal Bacteraemia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Tonsillitis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Urinary Tract Infection 2/1637 (0.1%) 2 0/1621 (0%) 0
    Urinary Tract Infection Staphylococcal 0/1637 (0%) 0 1/1621 (0.1%) 1
    Urosepsis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Viral Infection 1/1637 (0.1%) 1 0/1621 (0%) 0
    Wound Infection 1/1637 (0.1%) 1 0/1621 (0%) 0
    Injury, poisoning and procedural complications
    Animal Bite 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ankle Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Endotracheal Intubation Complication 1/1637 (0.1%) 1 0/1621 (0%) 0
    Fall 3/1637 (0.2%) 3 4/1621 (0.2%) 4
    Femur Fracture 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Limb Injury 0/1637 (0%) 0 1/1621 (0.1%) 1
    Lumbar Vertebral Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Patella Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pelvic Fracture 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Pneumothorax Traumatic 1/1637 (0.1%) 1 0/1621 (0%) 0
    Radius Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Rib Fracture 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Road Traffic Accident 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Skull Fracture 0/1637 (0%) 0 1/1621 (0.1%) 1
    Spinal Compression Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Sternal Fracture 1/1637 (0.1%) 1 0/1621 (0%) 0
    Subdural Haematoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Tendon Rupture 0/1637 (0%) 0 1/1621 (0.1%) 1
    Tibia Fracture 0/1637 (0%) 0 1/1621 (0.1%) 1
    Upper Limb Fracture 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ureteric Injury 0/1637 (0%) 0 1/1621 (0.1%) 1
    Investigations
    Alanine Aminotransferase Increased 0/1637 (0%) 0 1/1621 (0.1%) 1
    Electrocardiogram Qt Prolonged 0/1637 (0%) 0 1/1621 (0.1%) 1
    Electrocardiogram St Segment Elevation 1/1637 (0.1%) 1 0/1621 (0%) 0
    Liver Function Test Increased 1/1637 (0.1%) 1 0/1621 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 4/1637 (0.2%) 5 2/1621 (0.1%) 2
    Diabetes Mellitus Inadequate Control 1/1637 (0.1%) 1 0/1621 (0%) 0
    Diabetic Ketoacidosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Fluid Overload 1/1637 (0.1%) 1 0/1621 (0%) 0
    Hyperglycaemia 3/1637 (0.2%) 3 1/1621 (0.1%) 1
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome 1/1637 (0.1%) 1 0/1621 (0%) 0
    Hyperkalaemia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Hypoglycaemia 2/1637 (0.1%) 2 4/1621 (0.2%) 5
    Hypokalaemia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Lactic Acidosis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Malnutrition 1/1637 (0.1%) 1 0/1621 (0%) 0
    Metabolic Acidosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Obesity 0/1637 (0%) 0 1/1621 (0.1%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Back Pain 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Costochondritis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Intervertebral Disc Disorder 1/1637 (0.1%) 1 0/1621 (0%) 0
    Muscular Weakness 0/1637 (0%) 0 1/1621 (0.1%) 1
    Neuropathic Arthropathy 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Osteoarthritis 5/1637 (0.3%) 5 2/1621 (0.1%) 2
    Spinal Osteoarthritis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Spondylolisthesis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma Of Colon 0/1637 (0%) 0 1/1621 (0.1%) 1
    Basal Cell Carcinoma 3/1637 (0.2%) 3 0/1621 (0%) 0
    Benign Neoplasm Of Thyroid Gland 0/1637 (0%) 0 1/1621 (0.1%) 1
    Benign Ovarian Tumour 1/1637 (0.1%) 1 0/1621 (0%) 0
    Bladder Cancer 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Bladder Transitional Cell Carcinoma Recurrent 0/1637 (0%) 0 1/1621 (0.1%) 1
    Breast Cancer 0/1637 (0%) 0 1/1621 (0.1%) 1
    Breast Cancer Metastatic 1/1637 (0.1%) 1 0/1621 (0%) 0
    Clear Cell Renal Cell Carcinoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Colon Adenoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Diffuse Large B-Cell Lymphoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Endometrial Adenocarcinoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Endometrial Cancer 1/1637 (0.1%) 1 0/1621 (0%) 0
    Gallbladder Adenocarcinoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Gastric Cancer 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hepatocellular Carcinoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Intraductal Proliferative Breast Lesion 0/1637 (0%) 0 1/1621 (0.1%) 1
    Invasive Ductal Breast Carcinoma 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Lung Cancer Metastatic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Lung Neoplasm Malignant 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Lymphoma 0/1637 (0%) 0 2/1621 (0.1%) 2
    Malignant Neoplasm Of Ampulla Of Vater 1/1637 (0.1%) 1 0/1621 (0%) 0
    Meningioma Benign 2/1637 (0.1%) 2 0/1621 (0%) 0
    Metastases To Bone 0/1637 (0%) 0 1/1621 (0.1%) 1
    Neurilemmoma Benign 0/1637 (0%) 0 1/1621 (0.1%) 1
    Non-Hodgkin's Lymphoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Oesophageal Cancer Metastatic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ovarian Epithelial Cancer 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pancreatic Carcinoma 2/1637 (0.1%) 2 0/1621 (0%) 0
    Pancreatic Carcinoma Metastatic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Peripheral T-Cell Lymphoma Unspecified Stage Iv 0/1637 (0%) 0 1/1621 (0.1%) 1
    Plasma Cell Myeloma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Prostate Cancer 3/1637 (0.2%) 3 1/1621 (0.1%) 1
    Spindle Cell Sarcoma 0/1637 (0%) 0 1/1621 (0.1%) 1
    Squamous Cell Carcinoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Squamous Cell Carcinoma Of Lung 0/1637 (0%) 0 1/1621 (0.1%) 1
    Thyroid Cancer Metastatic 0/1637 (0%) 0 1/1621 (0.1%) 1
    Tonsil Cancer 1/1637 (0.1%) 1 0/1621 (0%) 0
    Transitional Cell Carcinoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Uterine Leiomyoma 1/1637 (0.1%) 1 0/1621 (0%) 0
    Nervous system disorders
    Amnesia 0/1637 (0%) 0 1/1621 (0.1%) 1
    Arachnoiditis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Carotid Arteriosclerosis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Carotid Artery Stenosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cerebral Atrophy 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cerebral Haemorrhage 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cerebral Infarction 1/1637 (0.1%) 1 0/1621 (0%) 0
    Cerebrovascular Accident 6/1637 (0.4%) 6 3/1621 (0.2%) 3
    Cervical Radiculopathy 1/1637 (0.1%) 1 0/1621 (0%) 0
    Dizziness 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Encephalopathy 0/1637 (0%) 0 1/1621 (0.1%) 1
    Focal Dyscognitive Seizures 0/1637 (0%) 0 1/1621 (0.1%) 1
    Haemorrhagic Stroke 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hypertensive Encephalopathy 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hypoglycaemic Unconsciousness 1/1637 (0.1%) 1 2/1621 (0.1%) 3
    Ischaemic Stroke 2/1637 (0.1%) 2 0/1621 (0%) 0
    Lacunar Infarction 0/1637 (0%) 0 1/1621 (0.1%) 1
    Lateral Medullary Syndrome 1/1637 (0.1%) 1 0/1621 (0%) 0
    Metabolic Encephalopathy 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Migraine 1/1637 (0.1%) 1 0/1621 (0%) 0
    Myelopathy 1/1637 (0.1%) 1 0/1621 (0%) 0
    Nerve Compression 1/1637 (0.1%) 1 0/1621 (0%) 0
    Seizure 1/1637 (0.1%) 1 0/1621 (0%) 0
    Syncope 2/1637 (0.1%) 3 2/1621 (0.1%) 2
    Transient Ischaemic Attack 3/1637 (0.2%) 3 3/1621 (0.2%) 3
    Tremor 1/1637 (0.1%) 1 0/1621 (0%) 0
    Product Issues
    Device Loosening 1/1637 (0.1%) 1 0/1621 (0%) 0
    Psychiatric disorders
    Depression 0/1637 (0%) 0 3/1621 (0.2%) 3
    Suicidal Ideation 0/1637 (0%) 0 1/1621 (0.1%) 1
    Suicide Attempt 0/1637 (0%) 0 1/1621 (0.1%) 1
    Renal and urinary disorders
    Acute Kidney Injury 8/1637 (0.5%) 8 9/1621 (0.6%) 10
    Calculus Bladder 0/1637 (0%) 0 1/1621 (0.1%) 1
    Diabetic Nephropathy 0/1637 (0%) 0 1/1621 (0.1%) 1
    Haematuria 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Nephrolithiasis 2/1637 (0.1%) 2 4/1621 (0.2%) 4
    Renal Failure 3/1637 (0.2%) 3 0/1621 (0%) 0
    Renal Impairment 1/1637 (0.1%) 1 0/1621 (0%) 0
    Ureteric Obstruction 0/1637 (0%) 0 1/1621 (0.1%) 1
    Ureterolithiasis 0/1637 (0%) 0 2/1621 (0.1%) 2
    Urinary Bladder Polyp 1/1637 (0.1%) 1 0/1621 (0%) 0
    Urinary Retention 0/1637 (0%) 0 1/1621 (0.1%) 1
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia 0/1637 (0%) 0 2/1621 (0.1%) 2
    Menorrhagia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure 1/1637 (0.1%) 1 3/1621 (0.2%) 4
    Asthma 2/1637 (0.1%) 2 0/1621 (0%) 0
    Chronic Obstructive Pulmonary Disease 4/1637 (0.2%) 4 5/1621 (0.3%) 5
    Chronic Respiratory Failure 1/1637 (0.1%) 1 0/1621 (0%) 0
    Dyspnoea 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Epistaxis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Pleural Effusion 0/1637 (0%) 0 1/1621 (0.1%) 1
    Pulmonary Embolism 0/1637 (0%) 0 3/1621 (0.2%) 3
    Pulmonary Haemorrhage 0/1637 (0%) 0 1/1621 (0.1%) 1
    Pulmonary Hypertension 1/1637 (0.1%) 1 0/1621 (0%) 0
    Pulmonary Oedema 0/1637 (0%) 0 1/1621 (0.1%) 1
    Respiratory Arrest 1/1637 (0.1%) 1 0/1621 (0%) 0
    Respiratory Failure 4/1637 (0.2%) 4 0/1621 (0%) 0
    Skin and subcutaneous tissue disorders
    Angioedema 1/1637 (0.1%) 1 0/1621 (0%) 0
    Diabetic Foot 0/1637 (0%) 0 1/1621 (0.1%) 1
    Hyperhidrosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Necrobiosis Lipoidica Diabeticorum 0/1637 (0%) 0 1/1621 (0.1%) 1
    Skin Ulcer 2/1637 (0.1%) 2 1/1621 (0.1%) 1
    Stasis Dermatitis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Social circumstances
    Pregnancy Of Partner 0/1637 (0%) 0 1/1621 (0.1%) 1
    Vascular disorders
    Aortic Aneurysm 0/1637 (0%) 0 1/1621 (0.1%) 1
    Aortic Arteriosclerosis 0/1637 (0%) 0 1/1621 (0.1%) 1
    Brachiocephalic Artery Stenosis 1/1637 (0.1%) 1 0/1621 (0%) 0
    Deep Vein Thrombosis 0/1637 (0%) 0 2/1621 (0.1%) 2
    Hypertension 1/1637 (0.1%) 1 1/1621 (0.1%) 1
    Hypertensive Crisis 1/1637 (0.1%) 1 2/1621 (0.1%) 2
    Hypotension 2/1637 (0.1%) 3 0/1621 (0%) 0
    Peripheral Arterial Occlusive Disease 0/1637 (0%) 0 4/1621 (0.2%) 4
    Peripheral Artery Aneurysm 0/1637 (0%) 0 1/1621 (0.1%) 1
    Peripheral Artery Occlusion 0/1637 (0%) 0 1/1621 (0.1%) 1
    Peripheral Ischaemia 1/1637 (0.1%) 1 0/1621 (0%) 0
    Other (Not Including Serious) Adverse Events
    Toujeo Standard of Care Basal Insulin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/1637 (0%) 0/1621 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

    Results Point of Contact

    Name/Title Trial Transparency Team
    Organization Sanofi aventis recherche & développement
    Phone 800-633-1610 ext 1#
    Email Contact-US@sanofi.com
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT02451137
    Other Study ID Numbers:
    • LPS14347
    • U1111-1168-0354
    First Posted:
    May 21, 2015
    Last Update Posted:
    Sep 10, 2019
    Last Verified:
    Aug 1, 2019