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
2 other identifiers
interventional
3,304
2 countries
427
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Jun 2015
Longer than P75 for phase_4 diabetes-mellitus-type-2
427 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedStudy Start
First participant enrolled
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2018
CompletedResults Posted
Study results publicly available
May 1, 2019
CompletedSeptember 10, 2019
August 1, 2019
2.7 years
May 19, 2015
March 1, 2019
August 28, 2019
Conditions
Outcome Measures
Primary Outcomes (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
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 Outcomes (12)
Change From Baseline in HbA1c at Month 6 and Month 12
Baseline, Month 6, Month 12
Treatment Persistence Measured by Medication Possession Ratio (MPR)
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
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
Baseline to Month 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12
Baseline, Month 6, Month 12
- +7 more secondary outcomes
Study Arms (2)
Toujeo
EXPERIMENTALToujeo® (Insulin glargine, 300 units per millilitre \[U/mL\]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program.
Standard of Care
ACTIVE COMPARATORLantus® (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.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (427)
Investigational Site Number 840731
Birmingham, Alabama, 35205, United States
Investigational Site Number 840305
Birmingham, Alabama, 35211, United States
Investigational Site Number 840811
Birmingham, Alabama, 35235, United States
Investigational Site Number 840218
Gulf Shores, Alabama, 36542, United States
Investigational Site Number 840739
Guntersville, Alabama, 35976, United States
Investigational Site Number 840367
Huntsville, Alabama, 35801, United States
Investigational Site Number 840130
Montgomery, Alabama, 36104, United States
Investigational Site Number 840729
Montgomery, Alabama, 36109, United States
Investigational Site Number 840281
Saraland, Alabama, 36571, United States
Investigational Site Number 840613
Sheffield, Alabama, 35660, United States
Investigational Site Number 840634
Sheffield, Alabama, 35660, United States
Investigational Site Number 840654
Sheffield, Alabama, 35660, United States
Investigational Site Number 840173
Phoenix, Arizona, 85032, United States
Investigational Site Number 840555
Phoenix, Arizona, 85037, United States
Investigational Site Number 840805
Sun City, Arizona, 85351, United States
Investigational Site Number 840725
Conway, Arkansas, 72034, United States
Investigational Site Number 840790
Jonesboro, Arkansas, 72401, United States
Investigational Site Number 840699
Little Rock, Arkansas, 72204, United States
Investigational Site Number 840528
Little Rock, Arkansas, 72205, United States
Investigational Site Number 840079
Searcy, Arkansas, 72143, United States
Investigational Site Number 840337
Bakersfield, California, 93304, United States
Investigational Site Number 840089
El Cajon, California, 92020, United States
Investigational Site Number 840024
Escondido, California, 92025, United States
Investigational Site Number 840020
Fresno, California, 93721, United States
Investigational Site Number 840470
Imperial, California, 92251, United States
Investigational Site Number 840155
Inglewood, California, 90301, United States
Investigational Site Number 840161
Inglewood, California, 90301, United States
Investigational Site Number 840194
Laguna Hills, California, 92653, United States
Investigational Site Number 840710
Laguna Hills, California, 92653, United States
Investigational Site Number 840204
Lancaster, California, 93534, United States
Investigational Site Number 840371
Los Angeles, California, 90017, United States
Investigational Site Number 840310
Los Angeles, California, 90036, United States
Investigational Site Number 840504
Los Angeles, California, 90036, United States
Investigational Site Number 840340
Los Angeles, California, 90057, United States
Investigational Site Number 840309
Los Gatos, California, 95032, United States
Investigational Site Number 840256
North Hollywood, California, 91606, United States
Investigational Site Number 840015
Northridge, California, 91325, United States
Investigational Site Number 840056
Norwalk, California, 90650, United States
Investigational Site Number 840090
Orange, California, 92868, United States
Investigational Site Number 840078
Palm Springs, California, 92262, United States
Investigational Site Number 840791
Palmdale, California, 93551, United States
Investigational Site Number 840216
Paramount, California, 90723, United States
Investigational Site Number 840413
Pomona, California, 91767, United States
Investigational Site Number 840244
Port Hueneme, California, 93041, United States
Investigational Site Number 840162
San Diego, California, 92111-6342, United States
Investigational Site Number 840028
San Diego, California, 92117-4961, United States
Investigational Site Number 840383
San Dimas, California, 91773, United States
Investigational Site Number 840627
San Jose, California, 95148, United States
Investigational Site Number 840120
San Ramon, California, 94583, United States
Investigational Site Number 840156
Santa Ana, California, 92704, United States
Investigational Site Number 840266
Sherman Oaks, California, 91403, United States
Investigational Site Number 840091
Sylmar, California, 91342, United States
Investigational Site Number 840208
Thousand Oaks, California, 91360, United States
Investigational Site Number 840115
Torrance, California, 90505, United States
Investigational Site Number 840792
Torrance, California, 90601, United States
Investigational Site Number 840612
Tulare, California, 93274, United States
Investigational Site Number 840467
Upland, California, 91786, United States
Investigational Site Number 840185
Vista, California, 92083, United States
Investigational Site Number 840472
Whittier, California, 90606, United States
Investigational Site Number 840411
Aurora, Colorado, 80014, United States
Investigational Site Number 840596
Denver, Colorado, 80209, United States
Investigational Site Number 840170
Denver, Colorado, 80246, United States
Investigational Site Number 840188
Englewood, Colorado, 80113, United States
Investigational Site Number 840329
Littleton, Colorado, 80127, United States
Investigational Site Number 840728
Littleton, Colorado, 80128, United States
Investigational Site Number 840687
Northglenn, Colorado, 80234, United States
Investigational Site Number 840643
Aventura, Florida, 33180, United States
Investigational Site Number 840652
Boca Raton, Florida, 33433, United States
Investigational Site Number 840449
Bradenton, Florida, 34209, United States
Investigational Site Number 840081
Cooper City, Florida, 33024, United States
Investigational Site Number 840027
Coral Gables, Florida, 33134, United States
Investigational Site Number 840446
Coral Gables, Florida, 33134, United States
Investigational Site Number 840407
Cutler Bay, Florida, 33157, United States
Investigational Site Number 840083
Doral, Florida, 33122, United States
Investigational Site Number 840141
Fleming Island, Florida, 32003, United States
Investigational Site Number 840035
Fort Lauderdale, Florida, 33316, United States
Investigational Site Number 840068
Fort Lauderdale, Florida, 33316, United States
Investigational Site Number 840145
Hialeah, Florida, 33016, United States
Investigational Site Number 840142
Jacksonville, Florida, 322078334, United States
Investigational Site Number 840352
Jacksonville, Florida, 32216, United States
Investigational Site Number 840021
Jupiter, Florida, 33458, United States
Investigational Site Number 840639
Kissimmee, Florida, 34741, United States
Investigational Site Number 840640
Kissimmee, Florida, 34741, United States
Investigational Site Number 840777
Lake Clarke Shores, Florida, 33406, United States
Investigational Site Number 840362
Margate, Florida, 33063, United States
Investigational Site Number 840002
Miami, Florida, 33015, United States
Investigational Site Number 840012
Miami, Florida, 33126, United States
Investigational Site Number 840698
Miami, Florida, 33126, United States
Investigational Site Number 840102
Miami, Florida, 33136, United States
Investigational Site Number 840209
Miami, Florida, 33142, United States
Investigational Site Number 840014
Miami, Florida, 33144, United States
Investigational Site Number 840128
Miami, Florida, 33155, United States
Investigational Site Number 840143
Miami, Florida, 33155, United States
Investigational Site Number 840349
Miami, Florida, 33155, United States
Investigational Site Number 840758
Miami, Florida, 33155, United States
Investigational Site Number 840690
Miami, Florida, 33166, United States
Investigational Site Number 840415
Miami, Florida, 33174, United States
Investigational Site Number 840197
Miami, Florida, 33185, United States
Investigational Site Number 840414
Miami, Florida, 33189, United States
Investigational Site Number 840221
Miami Lakes, Florida, 33016, United States
Investigational Site Number 840303
Miami Lakes, Florida, 33326, United States
Investigational Site Number 840508
Ocala, Florida, 34471, United States
Investigational Site Number 840092
Ocoee, Florida, 34761, United States
Investigational Site Number 840118
Palm Harbor, Florida, 34684, United States
Investigational Site Number 840080
Panama City, Florida, 32401, United States
Investigational Site Number 840372
Plantation, Florida, 33313, United States
Investigational Site Number 840199
Port Charlotte, Florida, 33952, United States
Investigational Site Number 840538
Winter Haven, Florida, 33880, United States
Investigational Site Number 840261
Atlanta, Georgia, 30328, United States
Investigational Site Number 840232
Atlanta, Georgia, 30342, United States
Investigational Site Number 840129
Blue Ridge, Georgia, 30513, United States
Investigational Site Number 840820
Columbus, Georgia, 31904, United States
Investigational Site Number 840767
Decatur, Georgia, 30034, United States
Investigational Site Number 840812
Decatur, Georgia, 30035, United States
Investigational Site Number 840700
Dunwoody, Georgia, 30338, United States
Investigational Site Number 840648
East Point, Georgia, 30344, United States
Investigational Site Number 840110
Lawrenceville, Georgia, United States
Investigational Site Number 840444
Macon, Georgia, 31210, United States
Investigational Site Number 840003
Marietta, Georgia, 30067, United States
Investigational Site Number 840632
Sandersville, Georgia, 31082, United States
Investigational Site Number 840616
Savannah, Georgia, 31404, United States
Investigational Site Number 840591
Savannah, Georgia, 31406, United States
Investigational Site Number 840727
Smyrna, Georgia, 30082, United States
Investigational Site Number 840520
Snellville, Georgia, 30078, United States
Investigational Site Number 840163
Statesboro, Georgia, 30461, United States
Investigational Site Number 840297
Stockbridge, Georgia, 30281, United States
Investigational Site Number 840715
Thomson, Georgia, 30824, United States
Investigational Site Number 840400
Blackfoot, Idaho, 83221, United States
Investigational Site Number 840764
Boise, Idaho, 83642, United States
Investigational Site Number 840005
Chicago, Illinois, 60607, United States
Investigational Site Number 840399
Chicago, Illinois, 60607, United States
Investigational Site Number 840301
Elgin, Illinois, 60124, United States
Investigational Site Number 840402
Joliet, Illinois, 60435, United States
Investigational Site Number 840226
Morton, Illinois, 61550, United States
Investigational Site Number 840318
Peoria, Illinois, 61602, United States
Investigational Site Number 840125
Avon, Indiana, 46123, United States
Investigational Site Number 840344
Brownsburg, Indiana, 46112, United States
Investigational Site Number 840007
Evansville, Indiana, 47714, United States
Investigational Site Number 840164
Evansville, Indiana, 47714, United States
Investigational Site Number 840324
Evansville, Indiana, 47715, United States
Investigational Site Number 840022
Franklin, Indiana, 46131, United States
Investigational Site Number 840536
Greenfield, Indiana, 46140, United States
Investigational Site Number 840582
Indianapolis, Indiana, 46254, United States
Investigational Site Number 840694
Michigan City, Indiana, 46360, United States
Investigational Site Number 840052
Muncie, Indiana, 47304, United States
Investigational Site Number 840786
New Albany, Indiana, 47150, United States
Investigational Site Number 840686
Council Bluffs, Iowa, 51501, United States
Investigational Site Number 840175
Des Moines, Iowa, 50134, United States
Investigational Site Number 840466
West Des Moines, Iowa, 50266, United States
Investigational Site Number 840134
Topeka, Kansas, 66606, United States
Investigational Site Number 840801
Ashland, Kentucky, 41101, United States
Investigational Site Number 840754
Benton, Kentucky, 42025, United States
Investigational Site Number 840342
Covington, Kentucky, 41011, United States
Investigational Site Number 840713
Elizabethtown, Kentucky, 42701, United States
Investigational Site Number 840681
Hopkinsville, Kentucky, 42240, United States
Investigational Site Number 840578
Louisville, Kentucky, 40202, United States
Investigational Site Number 840478
Owensboro, Kentucky, 42303, United States
Investigational Site Number 840576
Owensboro, Kentucky, 42303, United States
Investigational Site Number 840819
Owensboro, Kentucky, 42320, United States
Investigational Site Number 840645
Paris, Kentucky, 40361, United States
Investigational Site Number 840741
Versailles, Kentucky, 40383, United States
Investigational Site Number 840592
Covington, Louisiana, 70433, United States
Investigational Site Number 840744
Covington, Louisiana, 70433, United States
Investigational Site Number 840532
Crowley, Louisiana, 70526, United States
Investigational Site Number 840760
Hammond, Louisiana, 70403, United States
Investigational Site Number 840463
Lake Charles, Louisiana, 70601, United States
Investigational Site Number 840675
Marrero, Louisiana, 70072, United States
Investigational Site Number 840133
Metairie, Louisiana, 70006, United States
Investigational Site Number 840622
Monroe, Louisiana, 71203, United States
Investigational Site Number 840147
Natchitoches, Louisiana, 71457, United States
Investigational Site Number 840609
New Orleans, Louisiana, 70115, United States
Investigational Site Number 840311
Shreveport, Louisiana, 71105, United States
Investigational Site Number 840619
Slidell, Louisiana, 70458, United States
Investigational Site Number 840673
Zachary, Louisiana, 70791, United States
Investigational Site Number 840387
Bangor, Maine, 04401, United States
Investigational Site Number 840689
Portland, Maine, 04101, United States
Investigational Site Number 840534
Baltimore, Maryland, 21218, United States
Investigational Site Number 840455
Catonsville, Maryland, 21228, United States
Investigational Site Number 840393
Rockville, Maryland, 20852, United States
Investigational Site Number 840423
Boston, Massachusetts, 02115, United States
Investigational Site Number 840117
Alpena, Michigan, 49707, United States
Investigational Site Number 840289
Detroit, Michigan, 48235, United States
Investigational Site Number 840053
Essexville, Michigan, 48732, United States
Investigational Site Number 840150
Flint, Michigan, 48504, United States
Investigational Site Number 840184
Flint, Michigan, 48532, United States
Investigational Site Number 840236
Kalamazoo, Michigan, 49009, United States
Investigational Site Number 840210
Southfield, Michigan, United States
Investigational Site Number 840258
Stevensville, Michigan, 49127, United States
Investigational Site Number 840158
Troy, Michigan, 48085, United States
Investigational Site Number 840524
Troy, Michigan, 48098, United States
Investigational Site Number 840033
Olive Branch, Mississippi, 38654, United States
Investigational Site Number 840302
Bridgeton, Missouri, 63044, United States
Investigational Site Number 840693
Chesterfield, Missouri, 63017, United States
Investigational Site Number 840041
Jefferson City, Missouri, 65109, United States
Investigational Site Number 840711
St Louis, Missouri, 63128, United States
Investigational Site Number 840753
Billings, Montana, 59102, United States
Investigational Site Number 840603
Butte, Montana, 59701, United States
Investigational Site Number 840264
Elkhorn, Nebraska, 68022, United States
Investigational Site Number 840742
Omaha, Nebraska, 68144, United States
Investigational Site Number 840294
Henderson, Nevada, 89014, United States
Investigational Site Number 840087
Henderson, Nevada, 89052, United States
Investigational Site Number 840664
Las Vegas, Nevada, 89101, United States
Investigational Site Number 840108
Las Vegas, Nevada, 89106, United States
Investigational Site Number 840412
Las Vegas, Nevada, 89109, United States
Investigational Site Number 840656
Las Vegas, Nevada, 89117, United States
Investigational Site Number 840638
Las Vegas, Nevada, 89118, United States
Investigational Site Number 840750
Las Vegas, Nevada, 89121, United States
Investigational Site Number 840815
Las Vegas, Nevada, 89144, United States
Investigational Site Number 840761
Reno, Nevada, 89511, United States
Investigational Site Number 840144
Nashua, New Hampshire, 03063-4068, United States
Investigational Site Number 840799
Edison, New Jersey, 08837, United States
Investigational Site Number 840167
Linden, New Jersey, 07036, United States
Investigational Site Number 840060
Neptune City, New Jersey, 07753, United States
Investigational Site Number 840679
Sicklerville, New Jersey, 08081, United States
Investigational Site Number 840559
Teaneck, New Jersey, 07666, United States
Investigational Site Number 840481
Albany, New York, 12206, United States
Investigational Site Number 840772
Amityville, New York, 11701, United States
Investigational Site Number 840746
Babylon, New York, 11702, United States
Investigational Site Number 840355
Brooklyn, New York, 11215, United States
Investigational Site Number 840136
Brooklyn, New York, United States
Investigational Site Number 840734
Forest Hills, New York, 11375, United States
Investigational Site Number 840659
Great Neck, New York, 11367, United States
Investigational Site Number 840644
Holbrook, New York, 11741, United States
Investigational Site Number 840159
Jamaica, New York, 11432, United States
Investigational Site Number 840148
Lake Success, New York, 11042, United States
Investigational Site Number 840253
Laurelton, New York, 11422, United States
Investigational Site Number 840789
Merrick, New York, 11566, United States
Investigational Site Number 840716
Nesconset, New York, 11767, United States
Investigational Site Number 840810
New Hyde Park, New York, 11040, United States
Investigational Site Number 840072
New Hyde Park, New York, 11042, United States
Investigational Site Number 840674
New Windsor, New York, 12553, United States
Investigational Site Number 840626
New York, New York, 10001, United States
Investigational Site Number 840586
New York, New York, 10128, United States
Investigational Site Number 840044
North Massapequa, New York, 11758-1802, United States
Investigational Site Number 840587
Smithtown, New York, 11787, United States
Investigational Site Number 840577
Staten Island, New York, 10301-3914, United States
Investigational Site Number 840773
Syosset, New York, 11791, United States
Investigational Site Number 840047
Yonkers, New York, 10704, United States
Investigational Site Number 840214
Asheville, North Carolina, 28803, United States
Investigational Site Number 840237
Burlington, North Carolina, 27215, United States
Investigational Site Number 840714
Burlington, North Carolina, 27215, United States
Investigational Site Number 840456
Charlotte, North Carolina, 28204, United States
Investigational Site Number 840312
Concord, North Carolina, 28025, United States
Investigational Site Number 840763
Greensboro, North Carolina, 27401, United States
Investigational Site Number 840611
Greensboro, North Carolina, 27405, United States
Investigational Site Number 840776
Greensboro, North Carolina, 27408, United States
Investigational Site Number 840361
Greenville, North Carolina, 27834, United States
Investigational Site Number 840705
High Point, North Carolina, 27262, United States
Investigational Site Number 840755
Lexington, North Carolina, 27292, United States
Investigational Site Number 840688
Mooresville, North Carolina, 28117, United States
Investigational Site Number 840747
Mooresville, North Carolina, 28117, United States
Investigational Site Number 840296
Morganton, North Carolina, 28655, United States
Investigational Site Number 840573
New Bern, North Carolina, 28562, United States
Investigational Site Number 840096
Salisbury, North Carolina, 28144, United States
Investigational Site Number 840697
Shelby, North Carolina, 28150, United States
Investigational Site Number 840636
Wilmington, North Carolina, 28401, United States
Investigational Site Number 840195
Wilson, North Carolina, 27893, United States
Investigational Site Number 840315
Winston-Salem, North Carolina, 27103, United States
Investigational Site Number 840545
Fargo, North Dakota, 58104, United States
Investigational Site Number 840077
Canal Fulton, Ohio, 44614, United States
Investigational Site Number 840738
Canton, Ohio, 44718, United States
Investigational Site Number 840064
Cincinnati, Ohio, 45212, United States
Investigational Site Number 840701
Cincinnati, Ohio, 45242, United States
Investigational Site Number 840779
Cleveland, Ohio, 44113, United States
Investigational Site Number 840380
Columbus, Ohio, 43201, United States
Investigational Site Number 840339
Columbus, Ohio, 43203, United States
Investigational Site Number 840063
Columbus, Ohio, 43207, United States
Investigational Site Number 840191
Columbus, Ohio, 43207, United States
Investigational Site Number 840752
Columbus, Ohio, 43213, United States
Investigational Site Number 840684
Elyria, Ohio, 44035, United States
Investigational Site Number 840663
Findlay, Ohio, 45840, United States
Investigational Site Number 840379
Franklin, Ohio, 45005, United States
Investigational Site Number 840126
Gallipolis, Ohio, 45631, United States
Investigational Site Number 840771
Kettering, Ohio, 45429, United States
Investigational Site Number 840257
Lancaster, Ohio, 43130, United States
Investigational Site Number 840584
Lyndhurst, Ohio, 44124, United States
Investigational Site Number 840165
Marion, Ohio, 43302, United States
Investigational Site Number 840800
Miamisburg, Ohio, 45342, United States
Investigational Site Number 840560
Tallmadge, Ohio, 44278, United States
Investigational Site Number 840515
Toledo, Ohio, 43623, United States
Investigational Site Number 840797
Vandalia, Ohio, 45377, United States
Investigational Site Number 840192
Wadsworth, Ohio, 44201, United States
Investigational Site Number 840389
Willoughby Hills, Ohio, 44094, United States
Investigational Site Number 840751
Wooster, Ohio, 44691, United States
Investigational Site Number 840262
Edmond, Oklahoma, 73034, United States
Investigational Site Number 840360
Midwest City, Oklahoma, 73110, United States
Investigational Site Number 840363
Oklahoma City, Oklahoma, 73104, United States
Investigational Site Number 840556
Oklahoma City, Oklahoma, 73112, United States
Investigational Site Number 840103
Bend, Oregon, 97702, United States
Investigational Site Number 840292
Altoona, Pennsylvania, 16602, United States
Investigational Site Number 840009
Beaver, Pennsylvania, 15009, United States
Investigational Site Number 840059
Downingtown, Pennsylvania, 19335, United States
Investigational Site Number 840181
Fleetwood, Pennsylvania, 19522, United States
Investigational Site Number 840743
Greensburg, Pennsylvania, 15601, United States
Investigational Site Number 840479
Huntingdon Valley, Pennsylvania, 19006, United States
Investigational Site Number 840712
Indiana, Pennsylvania, 15701, United States
Investigational Site Number 840523
Lansdale, Pennsylvania, 19446, United States
Investigational Site Number 840766
Levittown, Pennsylvania, 19056, United States
Investigational Site Number 840032
Penndel, Pennsylvania, 19047, United States
Investigational Site Number 840067
Philadelphia, Pennsylvania, 19102, United States
Investigational Site Number 840277
Philadelphia, Pennsylvania, 19107, United States
Investigational Site Number 840561
Philadelphia, Pennsylvania, 19114, United States
Investigational Site Number 840174
Philadelphia, Pennsylvania, 19146, United States
Investigational Site Number 840348
Pittsburgh, Pennsylvania, 15243, United States
Investigational Site Number 840669
Pottstown, Pennsylvania, 19464, United States
Investigational Site Number 840748
Sayre, Pennsylvania, 18840, United States
Investigational Site Number 840187
Smithfield, Pennsylvania, 15478, United States
Investigational Site Number 840287
Uniontown, Pennsylvania, 15401, United States
Investigational Site Number 840341
Uniontown, Pennsylvania, 15401, United States
Investigational Site Number 840378
Providence, Rhode Island, 02908, United States
Investigational Site Number 840491
Anderson, South Carolina, 29621, United States
Investigational Site Number 840732
Greenville, South Carolina, 29601, United States
Investigational Site Number 840043
Greer, South Carolina, 29651, United States
Investigational Site Number 840109
Murrells Inlet, South Carolina, 29576, United States
Investigational Site Number 840327
North Myrtle Beach, South Carolina, 29582, United States
Investigational Site Number 840759
Simpsonville, South Carolina, 29681, United States
Investigational Site Number 840628
Summerville, South Carolina, 29485, United States
Investigational Site Number 840717
Bristol, Tennessee, 37620, United States
Investigational Site Number 840160
Chattanooga, Tennessee, 37404, United States
Investigational Site Number 840794
Franklin, Tennessee, 37064, United States
Investigational Site Number 840171
Jackson, Tennessee, 38305, United States
Investigational Site Number 840550
Jackson, Tennessee, 38305, United States
Investigational Site Number 840132
Kingsport, Tennessee, 37660, United States
Investigational Site Number 840140
Knoxville, Tennessee, 37912, United States
Investigational Site Number 840625
Memphis, Tennessee, 38119, United States
Investigational Site Number 840299
Nashville, Tennessee, 37203, United States
Investigational Site Number 840381
New Tazewell, Tennessee, 37825, United States
Investigational Site Number 840213
Amarillo, Texas, 79106, United States
Investigational Site Number 840157
Corpus Christi, Texas, 78404, United States
Investigational Site Number 840011
Dallas, Texas, 75218, United States
Investigational Site Number 840313
Dallas, Texas, 75218, United States
Investigational Site Number 840013
Dallas, Texas, 75231, United States
Investigational Site Number 840034
Dallas, Texas, 75231, United States
Investigational Site Number 840333
Dallas, Texas, 75235, United States
Investigational Site Number 840405
Dallas, Texas, 75254, United States
Investigational Site Number 840330
El Paso, Texas, 79925, United States
Investigational Site Number 840307
Fort Worth, Texas, 76104, United States
Investigational Site Number 840182
Houston, Texas, 77008, United States
Investigational Site Number 840366
Houston, Texas, 77024, United States
Investigational Site Number 840608
Houston, Texas, 77043, United States
Investigational Site Number 840323
Houston, Texas, 77053, United States
Investigational Site Number 840502
Houston, Texas, 77070, United States
Investigational Site Number 840513
Houston, Texas, 77070, United States
Investigational Site Number 840377
Houston, Texas, 77079, United States
Investigational Site Number 840306
Houston, Texas, 77083-4436, United States
Investigational Site Number 840137
Houston, Texas, 77090, United States
Investigational Site Number 840521
Houston, Texas, 77090, United States
Investigational Site Number 840533
Houston, Texas, 77095, United States
Investigational Site Number 840211
Houston, Texas, 77099, United States
Investigational Site Number 840260
Humble, Texas, 77338, United States
Investigational Site Number 840403
Irving, Texas, 75039, United States
Investigational Site Number 840382
Lampasas, Texas, 76550, United States
Investigational Site Number 840680
Lubbock, Texas, 79423, United States
Investigational Site Number 840308
McAllen, Texas, 78503, United States
Investigational Site Number 840549
Mesquite, Texas, 75149, United States
Investigational Site Number 840351
Missouri City, Texas, 77459, United States
Investigational Site Number 840373
Palestine, Texas, 75801, United States
Investigational Site Number 840365
Pharr, Texas, 78577, United States
Investigational Site Number 840439
Plano, Texas, 75093, United States
Investigational Site Number 840707
Port Arthur, Texas, 77640, United States
Investigational Site Number 840692
Richmond, Texas, 77469, United States
Investigational Site Number 840431
San Antonio, Texas, 78215, United States
Investigational Site Number 840074
San Antonio, Texas, 78218, United States
Investigational Site Number 840691
San Antonio, Texas, 78221, United States
Investigational Site Number 840176
San Antonio, Texas, 78228, United States
Investigational Site Number 840135
San Antonio, Texas, 78229-3901, United States
Investigational Site Number 840018
San Antonio, Texas, 78229, United States
Investigational Site Number 840434
San Antonio, Texas, 78229, United States
Investigational Site Number 840390
San Antonio, Texas, 78249, United States
Investigational Site Number 840207
Schertz, Texas, 78154, United States
Investigational Site Number 840615
Sealy, Texas, 77474, United States
Investigational Site Number 840097
Sugar Land, Texas, 77478, United States
Investigational Site Number 840460
Sugar Land, Texas, 77478, United States
Investigational Site Number 840514
Sugar Land, Texas, 77478, United States
Investigational Site Number 840530
Sugar Land, Texas, 77479, United States
Investigational Site Number 840008
Waco, Texas, 76710, United States
Investigational Site Number 840593
Waco, Texas, 76712, United States
Investigational Site Number 840809
Waxahachie, Texas, 75165, United States
Investigational Site Number 840651
Webster, Texas, 77598, United States
Investigational Site Number 840392
Clinton, Utah, 84015, United States
Investigational Site Number 840228
Salt Lake City, Utah, 84107, United States
Investigational Site Number 840189
St. George, Utah, 84790, United States
Investigational Site Number 840765
West Jordan, Utah, 84088, United States
Investigational Site Number 840806
West Jordan, Utah, 84088, United States
Investigational Site Number 840580
Chatham, Virginia, 24541, United States
Investigational Site Number 840590
Chesapeake, Virginia, 23321, United States
Investigational Site Number 840788
Danville, Virginia, 24540, United States
Investigational Site Number 840706
Danville, Virginia, 24541, United States
Investigational Site Number 840736
Danville, Virginia, 24541, United States
Investigational Site Number 840575
Fredericksburg, Virginia, 22408, United States
Investigational Site Number 840662
Hampton, Virginia, 23666, United States
Investigational Site Number 840795
Lynchburg, Virginia, 24501, United States
Investigational Site Number 840605
Martinsville, Virginia, 24112, United States
Investigational Site Number 840620
Newport News, Virginia, 23606, United States
Investigational Site Number 840088
Norfolk, Virginia, United States
Investigational Site Number 840247
North Chesterfield, Virginia, 11042, United States
Investigational Site Number 840730
Pennington Gap, Virginia, 24277, United States
Investigational Site Number 840179
Richmond, Virginia, 23219, United States
Investigational Site Number 840076
Salem, Virginia, United States
Investigational Site Number 840354
Virginia Beach, Virginia, 23462, United States
Investigational Site Number 840704
Winchester, Virginia, 22601, United States
Investigational Site Number 840709
Everett, Washington, 98208, United States
Investigational Site Number 840238
Federal Way, Washington, 98003-8708, United States
Investigational Site Number 840588
Vancouver, Washington, 98664, United States
Investigational Site Number 840084
Walla Walla, Washington, 99362, United States
Investigational Site Number 840658
Charleston, West Virginia, 25304, United States
Investigational Site Number 840595
Lewisburg, West Virginia, 24901, United States
Investigational Site Number 124002
Barrie, L4N4L3, Canada
Investigational Site Number 124005
Brampton, L6S0C9, Canada
Investigational Site Number 124001
Brampton, L6T4V3, Canada
Investigational Site Number 124030
Burlington, L7R1A4, Canada
Investigational Site Number 124017
Calgary, T2H2G4, Canada
Investigational Site Number 124013
Concord, L4K4M2, Canada
Investigational Site Number 124018
Etobicoke, M9R4E1, Canada
Investigational Site Number 124014
Etobicoke, M9V4V4, Canada
Investigational Site Number 124026
Guelph, N1H1B1, Canada
Investigational Site Number 124008
Hamilton, L8K3P3, Canada
Investigational Site Number 124027
Hamilton, L8L5G8, Canada
Investigational Site Number 124010
London, N5W 6A2, Canada
Investigational Site Number 124015
Markham, L6B0P9, Canada
Investigational Site Number 124020
Montreal, H2R1V6, Canada
Investigational Site Number 124016
Newmarket, Canada
Investigational Site Number 124024
Oakville, L6M1M1, Canada
Investigational Site Number 124029
Saint-Laurent, H4T1Z9, Canada
Investigational Site Number 124007
Surrey, V4A1R6, Canada
Investigational Site Number 124003
Toronto, M4G3E8, Canada
Investigational Site Number 124025
Vancouver, V5X0C4, Canada
Related Publications (2)
Anderson J, Meneghini L, Hinnen D, Gill J, Coudert M, Evenou P, Munshi M. Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control. J Diabetes Complications. 2021 Apr;35(4):107831. doi: 10.1016/j.jdiacomp.2020.107831. Epub 2020 Dec 31.
PMID: 33509703DERIVEDOster G, Sullivan SD, Dalal MR, Kazemi MR, Rojeski M, Wysham CH, Sung J, Johnstone B, Cali AM, Wei LJ, Traylor L, Anhalt H, Hull M, Van Vleet J, Meneghini LF. Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naive patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):731-739. doi: 10.1080/00325481.2016.1241663. Epub 2016 Oct 24.
PMID: 27690710DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi aventis recherche & développement
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 21, 2015
Study Start
June 16, 2015
Primary Completion
March 2, 2018
Study Completion
August 9, 2018
Last Updated
September 10, 2019
Results First Posted
May 1, 2019
Record last verified: 2019-08