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

August 28, 2019 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3304

Phase

Phase 4

Contacts and Locations

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

Study Locations

Canada
- - Barrie, Canada, L4N4L3
    - Investigational Site Number 124002
  - Brampton, Canada, L6S0C9
    - Investigational Site Number 124005
  - Brampton, Canada, L6T4V3
    - Investigational Site Number 124001
  - Burlington, Canada, L7R1A4
    - Investigational Site Number 124030
  - Calgary, Canada, T2H2G4
    - Investigational Site Number 124017
  - Concord, Canada, L4K4M2
    - Investigational Site Number 124013
  - Etobicoke, Canada, M9R4E1
    - Investigational Site Number 124018
  - Etobicoke, Canada, M9V4V4
    - Investigational Site Number 124014
  - Guelph, Canada, N1H1B1
    - Investigational Site Number 124026
  - Hamilton, Canada, L8K3P3
    - Investigational Site Number 124008
  - Hamilton, Canada, L8L5G8
    - Investigational Site Number 124027
  - London, Canada, N5W 6A2
    - Investigational Site Number 124010
  - Markham, Canada, L6B0P9
    - Investigational Site Number 124015
  - Montreal, Canada, H2R1V6
    - Investigational Site Number 124020
  - Newmarket, Canada
    - Investigational Site Number 124016
  - Oakville, Canada, L6M1M1
    - Investigational Site Number 124024
  - Saint-Laurent, Canada, H4T1Z9
    - Investigational Site Number 124029
  - Surrey, Canada, V4A1R6
    - Investigational Site Number 124007
  - Toronto, Canada, M4G3E8
    - Investigational Site Number 124003
  - Vancouver, Canada, V5X0C4
    - Investigational Site Number 124025
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Investigational Site Number 840731
  - Birmingham, Alabama, United States, 35211
    - Investigational Site Number 840305
  - Birmingham, Alabama, United States, 35235
    - Investigational Site Number 840811
  - Gulf Shores, Alabama, United States, 36542
    - Investigational Site Number 840218
  - Guntersville, Alabama, United States, 35976
    - Investigational Site Number 840739
  - Huntsville, Alabama, United States, 35801
    - Investigational Site Number 840367
  - Montgomery, Alabama, United States, 36104
    - Investigational Site Number 840130
  - Montgomery, Alabama, United States, 36109
    - Investigational Site Number 840729
  - Saraland, Alabama, United States, 36571
    - Investigational Site Number 840281
  - Sheffield, Alabama, United States, 35660
    - Investigational Site Number 840613
  - Sheffield, Alabama, United States, 35660
    - Investigational Site Number 840634
  - Sheffield, Alabama, United States, 35660
    - Investigational Site Number 840654
- Arizona
  - Phoenix, Arizona, United States, 85032
    - Investigational Site Number 840173
  - Phoenix, Arizona, United States, 85037
    - Investigational Site Number 840555
  - Sun City, Arizona, United States, 85351
    - Investigational Site Number 840805
- Arkansas
  - Conway, Arkansas, United States, 72034
    - Investigational Site Number 840725
  - Jonesboro, Arkansas, United States, 72401
    - Investigational Site Number 840790
  - Little Rock, Arkansas, United States, 72204
    - Investigational Site Number 840699
  - Little Rock, Arkansas, United States, 72205
    - Investigational Site Number 840528
  - Searcy, Arkansas, United States, 72143
    - Investigational Site Number 840079
- California
  - Bakersfield, California, United States, 93304
    - Investigational Site Number 840337
  - El Cajon, California, United States, 92020
    - Investigational Site Number 840089
  - Escondido, California, United States, 92025
    - Investigational Site Number 840024
  - Fresno, California, United States, 93721
    - Investigational Site Number 840020
  - Imperial, California, United States, 92251
    - Investigational Site Number 840470
  - Inglewood, California, United States, 90301
    - Investigational Site Number 840155
  - Inglewood, California, United States, 90301
    - Investigational Site Number 840161
  - Laguna Hills, California, United States, 92653
    - Investigational Site Number 840194
  - Laguna Hills, California, United States, 92653
    - Investigational Site Number 840710
  - Lancaster, California, United States, 93534
    - Investigational Site Number 840204
  - Los Angeles, California, United States, 90017
    - Investigational Site Number 840371
  - Los Angeles, California, United States, 90036
    - Investigational Site Number 840310
  - Los Angeles, California, United States, 90036
    - Investigational Site Number 840504
  - Los Angeles, California, United States, 90057
    - Investigational Site Number 840340
  - Los Gatos, California, United States, 95032
    - Investigational Site Number 840309
  - North Hollywood, California, United States, 91606
    - Investigational Site Number 840256
  - Northridge, California, United States, 91325
    - Investigational Site Number 840015
  - Norwalk, California, United States, 90650
    - Investigational Site Number 840056
  - Orange, California, United States, 92868
    - Investigational Site Number 840090
  - Palm Springs, California, United States, 92262
    - Investigational Site Number 840078
  - Palmdale, California, United States, 93551
    - Investigational Site Number 840791
  - Paramount, California, United States, 90723
    - Investigational Site Number 840216
  - Pomona, California, United States, 91767
    - Investigational Site Number 840413
  - Port Hueneme, California, United States, 93041
    - Investigational Site Number 840244
  - San Diego, California, United States, 92111-6342
    - Investigational Site Number 840162
  - San Diego, California, United States, 92117-4961
    - Investigational Site Number 840028
  - San Dimas, California, United States, 91773
    - Investigational Site Number 840383
  - San Jose, California, United States, 95148
    - Investigational Site Number 840627
  - San Ramon, California, United States, 94583
    - Investigational Site Number 840120
  - Santa Ana, California, United States, 92704
    - Investigational Site Number 840156
  - Sherman Oaks, California, United States, 91403
    - Investigational Site Number 840266
  - Sylmar, California, United States, 91342
    - Investigational Site Number 840091
  - Thousand Oaks, California, United States, 91360
    - Investigational Site Number 840208
  - Torrance, California, United States, 90505
    - Investigational Site Number 840115
  - Torrance, California, United States, 90601
    - Investigational Site Number 840792
  - Tulare, California, United States, 93274
    - Investigational Site Number 840612
  - Upland, California, United States, 91786
    - Investigational Site Number 840467
  - Vista, California, United States, 92083
    - Investigational Site Number 840185
  - Whittier, California, United States, 90606
    - Investigational Site Number 840472
- Colorado
  - Aurora, Colorado, United States, 80014
    - Investigational Site Number 840411
  - Denver, Colorado, United States, 80209
    - Investigational Site Number 840596
  - Denver, Colorado, United States, 80246
    - Investigational Site Number 840170
  - Englewood, Colorado, United States, 80113
    - Investigational Site Number 840188
  - Littleton, Colorado, United States, 80127
    - Investigational Site Number 840329
  - Littleton, Colorado, United States, 80128
    - Investigational Site Number 840728
  - Northglenn, Colorado, United States, 80234
    - Investigational Site Number 840687
- Florida
  - Aventura, Florida, United States, 33180
    - Investigational Site Number 840643
  - Boca Raton, Florida, United States, 33433
    - Investigational Site Number 840652
  - Bradenton, Florida, United States, 34209
    - Investigational Site Number 840449
  - Cooper City, Florida, United States, 33024
    - Investigational Site Number 840081
  - Coral Gables, Florida, United States, 33134
    - Investigational Site Number 840027
  - Coral Gables, Florida, United States, 33134
    - Investigational Site Number 840446
  - Cutler Bay, Florida, United States, 33157
    - Investigational Site Number 840407
  - Doral, Florida, United States, 33122
    - Investigational Site Number 840083
  - Fleming Island, Florida, United States, 32003
    - Investigational Site Number 840141
  - Fort Lauderdale, Florida, United States, 33316
    - Investigational Site Number 840035
  - Fort Lauderdale, Florida, United States, 33316
    - Investigational Site Number 840068
  - Hialeah, Florida, United States, 33016
    - Investigational Site Number 840145
  - Jacksonville, Florida, United States, 322078334
    - Investigational Site Number 840142
  - Jacksonville, Florida, United States, 32216
    - Investigational Site Number 840352
  - Jupiter, Florida, United States, 33458
    - Investigational Site Number 840021
  - Kissimmee, Florida, United States, 34741
    - Investigational Site Number 840639
  - Kissimmee, Florida, United States, 34741
    - Investigational Site Number 840640
  - Lake Clarke Shores, Florida, United States, 33406
    - Investigational Site Number 840777
  - Margate, Florida, United States, 33063
    - Investigational Site Number 840362
  - Miami, Florida, United States, 33015
    - Investigational Site Number 840002
  - Miami, Florida, United States, 33126
    - Investigational Site Number 840012
  - Miami, Florida, United States, 33126
    - Investigational Site Number 840698
  - Miami, Florida, United States, 33136
    - Investigational Site Number 840102
  - Miami, Florida, United States, 33142
    - Investigational Site Number 840209
  - Miami, Florida, United States, 33144
    - Investigational Site Number 840014
  - Miami, Florida, United States, 33155
    - Investigational Site Number 840128
  - Miami, Florida, United States, 33155
    - Investigational Site Number 840143
  - Miami, Florida, United States, 33155
    - Investigational Site Number 840349
  - Miami, Florida, United States, 33155
    - Investigational Site Number 840758
  - Miami, Florida, United States, 33166
    - Investigational Site Number 840690
  - Miami, Florida, United States, 33174
    - Investigational Site Number 840415
  - Miami, Florida, United States, 33185
    - Investigational Site Number 840197
  - Miami, Florida, United States, 33189
    - Investigational Site Number 840414
  - Miami Lakes, Florida, United States, 33016
    - Investigational Site Number 840221
  - Miami Lakes, Florida, United States, 33326
    - Investigational Site Number 840303
  - Ocala, Florida, United States, 34471
    - Investigational Site Number 840508
  - Ocoee, Florida, United States, 34761
    - Investigational Site Number 840092
  - Palm Harbor, Florida, United States, 34684
    - Investigational Site Number 840118
  - Panama City, Florida, United States, 32401
    - Investigational Site Number 840080
  - Plantation, Florida, United States, 33313
    - Investigational Site Number 840372
  - Port Charlotte, Florida, United States, 33952
    - Investigational Site Number 840199
  - Winter Haven, Florida, United States, 33880
    - Investigational Site Number 840538
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Investigational Site Number 840261
  - Atlanta, Georgia, United States, 30342
    - Investigational Site Number 840232
  - Blue Ridge, Georgia, United States, 30513
    - Investigational Site Number 840129
  - Columbus, Georgia, United States, 31904
    - Investigational Site Number 840820
  - Decatur, Georgia, United States, 30034
    - Investigational Site Number 840767
  - Decatur, Georgia, United States, 30035
    - Investigational Site Number 840812
  - Dunwoody, Georgia, United States, 30338
    - Investigational Site Number 840700
  - East Point, Georgia, United States, 30344
    - Investigational Site Number 840648
  - Lawrenceville, Georgia, United States
    - Investigational Site Number 840110
  - Macon, Georgia, United States, 31210
    - Investigational Site Number 840444
  - Marietta, Georgia, United States, 30067
    - Investigational Site Number 840003
  - Sandersville, Georgia, United States, 31082
    - Investigational Site Number 840632
  - Savannah, Georgia, United States, 31404
    - Investigational Site Number 840616
  - Savannah, Georgia, United States, 31406
    - Investigational Site Number 840591
  - Smyrna, Georgia, United States, 30082
    - Investigational Site Number 840727
  - Snellville, Georgia, United States, 30078
    - Investigational Site Number 840520
  - Statesboro, Georgia, United States, 30461
    - Investigational Site Number 840163
  - Stockbridge, Georgia, United States, 30281
    - Investigational Site Number 840297
  - Thomson, Georgia, United States, 30824
    - Investigational Site Number 840715
- Idaho
  - Blackfoot, Idaho, United States, 83221
    - Investigational Site Number 840400
  - Boise, Idaho, United States, 83642
    - Investigational Site Number 840764
- Illinois
  - Chicago, Illinois, United States, 60607
    - Investigational Site Number 840005
  - Chicago, Illinois, United States, 60607
    - Investigational Site Number 840399
  - Elgin, Illinois, United States, 60124
    - Investigational Site Number 840301
  - Joliet, Illinois, United States, 60435
    - Investigational Site Number 840402
  - Morton, Illinois, United States, 61550
    - Investigational Site Number 840226
  - Peoria, Illinois, United States, 61602
    - Investigational Site Number 840318
- Indiana
  - Avon, Indiana, United States, 46123
    - Investigational Site Number 840125
  - Brownsburg, Indiana, United States, 46112
    - Investigational Site Number 840344
  - Evansville, Indiana, United States, 47714
    - Investigational Site Number 840007
  - Evansville, Indiana, United States, 47714
    - Investigational Site Number 840164
  - Evansville, Indiana, United States, 47715
    - Investigational Site Number 840324
  - Franklin, Indiana, United States, 46131
    - Investigational Site Number 840022
  - Greenfield, Indiana, United States, 46140
    - Investigational Site Number 840536
  - Indianapolis, Indiana, United States, 46254
    - Investigational Site Number 840582
  - Michigan City, Indiana, United States, 46360
    - Investigational Site Number 840694
  - Muncie, Indiana, United States, 47304
    - Investigational Site Number 840052
  - New Albany, Indiana, United States, 47150
    - Investigational Site Number 840786
- Iowa
  - Council Bluffs, Iowa, United States, 51501
    - Investigational Site Number 840686
  - Des Moines, Iowa, United States, 50134
    - Investigational Site Number 840175
  - West Des Moines, Iowa, United States, 50266
    - Investigational Site Number 840466
- Kansas
  - Topeka, Kansas, United States, 66606
    - Investigational Site Number 840134
- Kentucky
  - Ashland, Kentucky, United States, 41101
    - Investigational Site Number 840801
  - Benton, Kentucky, United States, 42025
    - Investigational Site Number 840754
  - Covington, Kentucky, United States, 41011
    - Investigational Site Number 840342
  - Elizabethtown, Kentucky, United States, 42701
    - Investigational Site Number 840713
  - Hopkinsville, Kentucky, United States, 42240
    - Investigational Site Number 840681
  - Louisville, Kentucky, United States, 40202
    - Investigational Site Number 840578
  - Owensboro, Kentucky, United States, 42303
    - Investigational Site Number 840478
  - Owensboro, Kentucky, United States, 42303
    - Investigational Site Number 840576
  - Owensboro, Kentucky, United States, 42320
    - Investigational Site Number 840819
  - Paris, Kentucky, United States, 40361
    - Investigational Site Number 840645
  - Versailles, Kentucky, United States, 40383
    - Investigational Site Number 840741
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Investigational Site Number 840592
  - Covington, Louisiana, United States, 70433
    - Investigational Site Number 840744
  - Crowley, Louisiana, United States, 70526
    - Investigational Site Number 840532
  - Hammond, Louisiana, United States, 70403
    - Investigational Site Number 840760
  - Lake Charles, Louisiana, United States, 70601
    - Investigational Site Number 840463
  - Marrero, Louisiana, United States, 70072
    - Investigational Site Number 840675
  - Metairie, Louisiana, United States, 70006
    - Investigational Site Number 840133
  - Monroe, Louisiana, United States, 71203
    - Investigational Site Number 840622
  - Natchitoches, Louisiana, United States, 71457
    - Investigational Site Number 840147
  - New Orleans, Louisiana, United States, 70115
    - Investigational Site Number 840609
  - Shreveport, Louisiana, United States, 71105
    - Investigational Site Number 840311
  - Slidell, Louisiana, United States, 70458
    - Investigational Site Number 840619
  - Zachary, Louisiana, United States, 70791
    - Investigational Site Number 840673
- Maine
  - Bangor, Maine, United States, 04401
    - Investigational Site Number 840387
  - Portland, Maine, United States, 04101
    - Investigational Site Number 840689
- Maryland
  - Baltimore, Maryland, United States, 21218
    - Investigational Site Number 840534
  - Catonsville, Maryland, United States, 21228
    - Investigational Site Number 840455
  - Rockville, Maryland, United States, 20852
    - Investigational Site Number 840393
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Investigational Site Number 840423
- Michigan
  - Alpena, Michigan, United States, 49707
    - Investigational Site Number 840117
  - Detroit, Michigan, United States, 48235
    - Investigational Site Number 840289
  - Essexville, Michigan, United States, 48732
    - Investigational Site Number 840053
  - Flint, Michigan, United States, 48504
    - Investigational Site Number 840150
  - Flint, Michigan, United States, 48532
    - Investigational Site Number 840184
  - Kalamazoo, Michigan, United States, 49009
    - Investigational Site Number 840236
  - Southfield, Michigan, United States
    - Investigational Site Number 840210
  - Stevensville, Michigan, United States, 49127
    - Investigational Site Number 840258
  - Troy, Michigan, United States, 48085
    - Investigational Site Number 840158
  - Troy, Michigan, United States, 48098
    - Investigational Site Number 840524
- Mississippi
  - Olive Branch, Mississippi, United States, 38654
    - Investigational Site Number 840033
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - Investigational Site Number 840302
  - Chesterfield, Missouri, United States, 63017
    - Investigational Site Number 840693
  - Jefferson City, Missouri, United States, 65109
    - Investigational Site Number 840041
  - Saint Louis, Missouri, United States, 63128
    - Investigational Site Number 840711
- Montana
  - Billings, Montana, United States, 59102
    - Investigational Site Number 840753
  - Butte, Montana, United States, 59701
    - Investigational Site Number 840603
- Nebraska
  - Elkhorn, Nebraska, United States, 68022
    - Investigational Site Number 840264
  - Omaha, Nebraska, United States, 68144
    - Investigational Site Number 840742
- Nevada
  - Henderson, Nevada, United States, 89014
    - Investigational Site Number 840294
  - Henderson, Nevada, United States, 89052
    - Investigational Site Number 840087
  - Las Vegas, Nevada, United States, 89101
    - Investigational Site Number 840664
  - Las Vegas, Nevada, United States, 89106
    - Investigational Site Number 840108
  - Las Vegas, Nevada, United States, 89109
    - Investigational Site Number 840412
  - Las Vegas, Nevada, United States, 89117
    - Investigational Site Number 840656
  - Las Vegas, Nevada, United States, 89118
    - Investigational Site Number 840638
  - Las Vegas, Nevada, United States, 89121
    - Investigational Site Number 840750
  - Las Vegas, Nevada, United States, 89144
    - Investigational Site Number 840815
  - Reno, Nevada, United States, 89511
    - Investigational Site Number 840761
- New Hampshire
  - Nashua, New Hampshire, United States, 03063-4068
    - Investigational Site Number 840144
- New Jersey
  - Edison, New Jersey, United States, 08837
    - Investigational Site Number 840799
  - Linden, New Jersey, United States, 07036
    - Investigational Site Number 840167
  - Neptune, New Jersey, United States, 07753
    - Investigational Site Number 840060
  - Sicklerville, New Jersey, United States, 08081
    - Investigational Site Number 840679
  - Teaneck, New Jersey, United States, 07666
    - Investigational Site Number 840559
- New York
  - Albany, New York, United States, 12206
    - Investigational Site Number 840481
  - Amityville, New York, United States, 11701
    - Investigational Site Number 840772
  - Babylon, New York, United States, 11702
    - Investigational Site Number 840746
  - Brooklyn, New York, United States, 11215
    - Investigational Site Number 840355
  - Brooklyn, New York, United States
    - Investigational Site Number 840136
  - Forest Hills, New York, United States, 11375
    - Investigational Site Number 840734
  - Great Neck, New York, United States, 11367
    - Investigational Site Number 840659
  - Holbrook, New York, United States, 11741
    - Investigational Site Number 840644
  - Jamaica, New York, United States, 11432
    - Investigational Site Number 840159
  - Lake Success, New York, United States, 11042
    - Investigational Site Number 840148
  - Laurelton, New York, United States, 11422
    - Investigational Site Number 840253
  - Merrick, New York, United States, 11566
    - Investigational Site Number 840789
  - Nesconset, New York, United States, 11767
    - Investigational Site Number 840716
  - New Hyde Park, New York, United States, 11040
    - Investigational Site Number 840810
  - New Hyde Park, New York, United States, 11042
    - Investigational Site Number 840072
  - New Windsor, New York, United States, 12553
    - Investigational Site Number 840674
  - New York, New York, United States, 10001
    - Investigational Site Number 840626
  - New York, New York, United States, 10128
    - Investigational Site Number 840586
  - North Massapequa, New York, United States, 11758-1802
    - Investigational Site Number 840044
  - Smithtown, New York, United States, 11787
    - Investigational Site Number 840587
  - Staten Island, New York, United States, 10301-3914
    - Investigational Site Number 840577
  - Syosset, New York, United States, 11791
    - Investigational Site Number 840773
  - Yonkers, New York, United States, 10704
    - Investigational Site Number 840047
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Investigational Site Number 840214
  - Burlington, North Carolina, United States, 27215
    - Investigational Site Number 840237
  - Burlington, North Carolina, United States, 27215
    - Investigational Site Number 840714
  - Charlotte, North Carolina, United States, 28204
    - Investigational Site Number 840456
  - Concord, North Carolina, United States, 28025
    - Investigational Site Number 840312
  - Greensboro, North Carolina, United States, 27401
    - Investigational Site Number 840763
  - Greensboro, North Carolina, United States, 27405
    - Investigational Site Number 840611
  - Greensboro, North Carolina, United States, 27408
    - Investigational Site Number 840776
  - Greenville, North Carolina, United States, 27834
    - Investigational Site Number 840361
  - High Point, North Carolina, United States, 27262
    - Investigational Site Number 840705
  - Lexington, North Carolina, United States, 27292
    - Investigational Site Number 840755
  - Mooresville, North Carolina, United States, 28117
    - Investigational Site Number 840688
  - Mooresville, North Carolina, United States, 28117
    - Investigational Site Number 840747
  - Morganton, North Carolina, United States, 28655
    - Investigational Site Number 840296
  - New Bern, North Carolina, United States, 28562
    - Investigational Site Number 840573
  - Salisbury, North Carolina, United States, 28144
    - Investigational Site Number 840096
  - Shelby, North Carolina, United States, 28150
    - Investigational Site Number 840697
  - Wilmington, North Carolina, United States, 28401
    - Investigational Site Number 840636
  - Wilson, North Carolina, United States, 27893
    - Investigational Site Number 840195
  - Winston-Salem, North Carolina, United States, 27103
    - Investigational Site Number 840315
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Investigational Site Number 840545
- Ohio
  - Canal Fulton, Ohio, United States, 44614
    - Investigational Site Number 840077
  - Canton, Ohio, United States, 44718
    - Investigational Site Number 840738
  - Cincinnati, Ohio, United States, 45212
    - Investigational Site Number 840064
  - Cincinnati, Ohio, United States, 45242
    - Investigational Site Number 840701
  - Cleveland, Ohio, United States, 44113
    - Investigational Site Number 840779
  - Columbus, Ohio, United States, 43201
    - Investigational Site Number 840380
  - Columbus, Ohio, United States, 43203
    - Investigational Site Number 840339
  - Columbus, Ohio, United States, 43207
    - Investigational Site Number 840063
  - Columbus, Ohio, United States, 43207
    - Investigational Site Number 840191
  - Columbus, Ohio, United States, 43213
    - Investigational Site Number 840752
  - Elyria, Ohio, United States, 44035
    - Investigational Site Number 840684
  - Findlay, Ohio, United States, 45840
    - Investigational Site Number 840663
  - Franklin, Ohio, United States, 45005
    - Investigational Site Number 840379
  - Gallipolis, Ohio, United States, 45631
    - Investigational Site Number 840126
  - Kettering, Ohio, United States, 45429
    - Investigational Site Number 840771
  - Lancaster, Ohio, United States, 43130
    - Investigational Site Number 840257
  - Lyndhurst, Ohio, United States, 44124
    - Investigational Site Number 840584
  - Marion, Ohio, United States, 43302
    - Investigational Site Number 840165
  - Miamisburg, Ohio, United States, 45342
    - Investigational Site Number 840800
  - Tallmadge, Ohio, United States, 44278
    - Investigational Site Number 840560
  - Toledo, Ohio, United States, 43623
    - Investigational Site Number 840515
  - Vandalia, Ohio, United States, 45377
    - Investigational Site Number 840797
  - Wadsworth, Ohio, United States, 44201
    - Investigational Site Number 840192
  - Willoughby Hills, Ohio, United States, 44094
    - Investigational Site Number 840389
  - Wooster, Ohio, United States, 44691
    - Investigational Site Number 840751
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Investigational Site Number 840262
  - Midwest City, Oklahoma, United States, 73110
    - Investigational Site Number 840360
  - Oklahoma City, Oklahoma, United States, 73104
    - Investigational Site Number 840363
  - Oklahoma City, Oklahoma, United States, 73112
    - Investigational Site Number 840556
- Oregon
  - Bend, Oregon, United States, 97702
    - Investigational Site Number 840103
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16602
    - Investigational Site Number 840292
  - Beaver, Pennsylvania, United States, 15009
    - Investigational Site Number 840009
  - Downingtown, Pennsylvania, United States, 19335
    - Investigational Site Number 840059
  - Fleetwood, Pennsylvania, United States, 19522
    - Investigational Site Number 840181
  - Greensburg, Pennsylvania, United States, 15601
    - Investigational Site Number 840743
  - Huntingdon Valley, Pennsylvania, United States, 19006
    - Investigational Site Number 840479
  - Indiana, Pennsylvania, United States, 15701
    - Investigational Site Number 840712
  - Lansdale, Pennsylvania, United States, 19446
    - Investigational Site Number 840523
  - Levittown, Pennsylvania, United States, 19056
    - Investigational Site Number 840766
  - Penndel, Pennsylvania, United States, 19047
    - Investigational Site Number 840032
  - Philadelphia, Pennsylvania, United States, 19102
    - Investigational Site Number 840067
  - Philadelphia, Pennsylvania, United States, 19107
    - Investigational Site Number 840277
  - Philadelphia, Pennsylvania, United States, 19114
    - Investigational Site Number 840561
  - Philadelphia, Pennsylvania, United States, 19146
    - Investigational Site Number 840174
  - Pittsburgh, Pennsylvania, United States, 15243
    - Investigational Site Number 840348
  - Pottstown, Pennsylvania, United States, 19464
    - Investigational Site Number 840669
  - Sayre, Pennsylvania, United States, 18840
    - Investigational Site Number 840748
  - Smithfield, Pennsylvania, United States, 15478
    - Investigational Site Number 840187
  - Uniontown, Pennsylvania, United States, 15401
    - Investigational Site Number 840287
  - Uniontown, Pennsylvania, United States, 15401
    - Investigational Site Number 840341
- Rhode Island
  - Providence, Rhode Island, United States, 02908
    - Investigational Site Number 840378
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Investigational Site Number 840491
  - Greenville, South Carolina, United States, 29601
    - Investigational Site Number 840732
  - Greer, South Carolina, United States, 29651
    - Investigational Site Number 840043
  - Murrells Inlet, South Carolina, United States, 29576
    - Investigational Site Number 840109
  - North Myrtle Beach, South Carolina, United States, 29582
    - Investigational Site Number 840327
  - Simpsonville, South Carolina, United States, 29681
    - Investigational Site Number 840759
  - Summerville, South Carolina, United States, 29485
    - Investigational Site Number 840628
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Investigational Site Number 840717
  - Chattanooga, Tennessee, United States, 37404
    - Investigational Site Number 840160
  - Franklin, Tennessee, United States, 37064
    - Investigational Site Number 840794
  - Jackson, Tennessee, United States, 38305
    - Investigational Site Number 840171
  - Jackson, Tennessee, United States, 38305
    - Investigational Site Number 840550
  - Kingsport, Tennessee, United States, 37660
    - Investigational Site Number 840132
  - Knoxville, Tennessee, United States, 37912
    - Investigational Site Number 840140
  - Memphis, Tennessee, United States, 38119
    - Investigational Site Number 840625
  - Nashville, Tennessee, United States, 37203
    - Investigational Site Number 840299
  - New Tazewell, Tennessee, United States, 37825
    - Investigational Site Number 840381
- Texas
  - Amarillo, Texas, United States, 79106
    - Investigational Site Number 840213
  - Corpus Christi, Texas, United States, 78404
    - Investigational Site Number 840157
  - Dallas, Texas, United States, 75218
    - Investigational Site Number 840011
  - Dallas, Texas, United States, 75218
    - Investigational Site Number 840313
  - Dallas, Texas, United States, 75231
    - Investigational Site Number 840013
  - Dallas, Texas, United States, 75231
    - Investigational Site Number 840034
  - Dallas, Texas, United States, 75235
    - Investigational Site Number 840333
  - Dallas, Texas, United States, 75254
    - Investigational Site Number 840405
  - El Paso, Texas, United States, 79925
    - Investigational Site Number 840330
  - Fort Worth, Texas, United States, 76104
    - Investigational Site Number 840307
  - Houston, Texas, United States, 77008
    - Investigational Site Number 840182
  - Houston, Texas, United States, 77024
    - Investigational Site Number 840366
  - Houston, Texas, United States, 77043
    - Investigational Site Number 840608
  - Houston, Texas, United States, 77053
    - Investigational Site Number 840323
  - Houston, Texas, United States, 77070
    - Investigational Site Number 840502
  - Houston, Texas, United States, 77070
    - Investigational Site Number 840513
  - Houston, Texas, United States, 77079
    - Investigational Site Number 840377
  - Houston, Texas, United States, 77083-4436
    - Investigational Site Number 840306
  - Houston, Texas, United States, 77090
    - Investigational Site Number 840137
  - Houston, Texas, United States, 77090
    - Investigational Site Number 840521
  - Houston, Texas, United States, 77095
    - Investigational Site Number 840533
  - Houston, Texas, United States, 77099
    - Investigational Site Number 840211
  - Humble, Texas, United States, 77338
    - Investigational Site Number 840260
  - Irving, Texas, United States, 75039
    - Investigational Site Number 840403
  - Lampasas, Texas, United States, 76550
    - Investigational Site Number 840382
  - Lubbock, Texas, United States, 79423
    - Investigational Site Number 840680
  - McAllen, Texas, United States, 78503
    - Investigational Site Number 840308
  - Mesquite, Texas, United States, 75149
    - Investigational Site Number 840549
  - Missouri City, Texas, United States, 77459
    - Investigational Site Number 840351
  - Palestine, Texas, United States, 75801
    - Investigational Site Number 840373
  - Pharr, Texas, United States, 78577
    - Investigational Site Number 840365
  - Plano, Texas, United States, 75093
    - Investigational Site Number 840439
  - Port Arthur, Texas, United States, 77640
    - Investigational Site Number 840707
  - Richmond, Texas, United States, 77469
    - Investigational Site Number 840692
  - San Antonio, Texas, United States, 78215
    - Investigational Site Number 840431
  - San Antonio, Texas, United States, 78218
    - Investigational Site Number 840074
  - San Antonio, Texas, United States, 78221
    - Investigational Site Number 840691
  - San Antonio, Texas, United States, 78228
    - Investigational Site Number 840176
  - San Antonio, Texas, United States, 78229-3901
    - Investigational Site Number 840135
  - San Antonio, Texas, United States, 78229
    - Investigational Site Number 840018
  - San Antonio, Texas, United States, 78229
    - Investigational Site Number 840434
  - San Antonio, Texas, United States, 78249
    - Investigational Site Number 840390
  - Schertz, Texas, United States, 78154
    - Investigational Site Number 840207
  - Sealy, Texas, United States, 77474
    - Investigational Site Number 840615
  - Sugar Land, Texas, United States, 77478
    - Investigational Site Number 840097
  - Sugar Land, Texas, United States, 77478
    - Investigational Site Number 840460
  - Sugar Land, Texas, United States, 77478
    - Investigational Site Number 840514
  - Sugar Land, Texas, United States, 77479
    - Investigational Site Number 840530
  - Waco, Texas, United States, 76710
    - Investigational Site Number 840008
  - Waco, Texas, United States, 76712
    - Investigational Site Number 840593
  - Waxahachie, Texas, United States, 75165
    - Investigational Site Number 840809
  - Webster, Texas, United States, 77598
    - Investigational Site Number 840651
- Utah
  - Clinton, Utah, United States, 84015
    - Investigational Site Number 840392
  - Saint George, Utah, United States, 84790
    - Investigational Site Number 840189
  - Salt Lake City, Utah, United States, 84107
    - Investigational Site Number 840228
  - West Jordan, Utah, United States, 84088
    - Investigational Site Number 840765
  - West Jordan, Utah, United States, 84088
    - Investigational Site Number 840806
- Virginia
  - Chatham, Virginia, United States, 24541
    - Investigational Site Number 840580
  - Chesapeake, Virginia, United States, 23321
    - Investigational Site Number 840590
  - Danville, Virginia, United States, 24540
    - Investigational Site Number 840788
  - Danville, Virginia, United States, 24541
    - Investigational Site Number 840706
  - Danville, Virginia, United States, 24541
    - Investigational Site Number 840736
  - Fredericksburg, Virginia, United States, 22408
    - Investigational Site Number 840575
  - Hampton, Virginia, United States, 23666
    - Investigational Site Number 840662
  - Lynchburg, Virginia, United States, 24501
    - Investigational Site Number 840795
  - Martinsville, Virginia, United States, 24112
    - Investigational Site Number 840605
  - Newport News, Virginia, United States, 23606
    - Investigational Site Number 840620
  - Norfolk, Virginia, United States
    - Investigational Site Number 840088
  - North Chesterfield, Virginia, United States, 11042
    - Investigational Site Number 840247
  - Pennington Gap, Virginia, United States, 24277
    - Investigational Site Number 840730
  - Richmond, Virginia, United States, 23219
    - Investigational Site Number 840179
  - Salem, Virginia, United States
    - Investigational Site Number 840076
  - Virginia Beach, Virginia, United States, 23462
    - Investigational Site Number 840354
  - Winchester, Virginia, United States, 22601
    - Investigational Site Number 840704
- Washington
  - Everett, Washington, United States, 98208
    - Investigational Site Number 840709
  - Federal Way, Washington, United States, 98003-8708
    - Investigational Site Number 840238
  - Vancouver, Washington, United States, 98664
    - Investigational Site Number 840588
  - Walla Walla, Washington, United States, 99362
    - Investigational Site Number 840084
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Investigational Site Number 840658
  - Lewisburg, West Virginia, United States, 24901
    - Investigational Site Number 840595

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: 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).	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c at Month 6 and Month 12 Time Frame: 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.	Baseline, Month 6, Month 12
Treatment Persistence Measured by Medication Possession Ratio (MPR) Time Frame: 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.	At Month 6 and Month 12
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 Time Frame: 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).	Baseline to Month 6
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 Time Frame: 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).	Baseline to Month 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12 Time Frame: 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.	Baseline, Month 6, Month 12
Change From Baseline in Body Weight at Month 6 and Month 12 Time Frame: 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.	Baseline, Month 6, Month 12
Change From Baseline in Basal Insulin Dose at Month 6 and Month 12 Time Frame: Baseline, Month 6, Month 12	Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.	Baseline, Month 6, Month 12
Percentage of Responders (Participants and Provider) Who Reported "Excellent" or "Good" Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12 Time Frame: 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.	At Month 6, Month 12
Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12 Time Frame: 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.	At Baseline, Month 6, Month 12
Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12 Time Frame: 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).	At Month 12
Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12 Time Frame: 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.	From Baseline to Month 6 and Month 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 Time Frame: 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).	Up to Month 6 and Month 12

Collaborators and Investigators

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

Sponsor

Sanofi

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (ACTUAL)

June 16, 2015

Primary Completion (ACTUAL)

March 2, 2018

Study Completion (ACTUAL)

August 9, 2018

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (ESTIMATE)

May 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

LPS14347
U1111-1168-0354 (OTHER: UTN)

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

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Sanofi

Completed

Characteristics of Glargine in Type 2 Diabetics

Type 2 Diabetes

United States
Sanofi

Completed

Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist (BRIGHT)

Diabetes Mellitus, Type 2

Israel, Czechia, Greece, Italy, United States, Bulgaria, Croatia, Denmark, France, Hungary, Romania, Serbia, Slovakia, Sweden, Switzerland, United Kingdom

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Insulin glargine, 300 U/ml

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Conditions

Rare Diseases

Drug Interventions

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