AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 4NCT02451137

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

A Phase 4 study testing Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml and Insulin detemir in people with Diabetes Mellitus, Type 2, run by Sanofi at 427 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml and Insulin detemir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,304 participants
Where
427 sitesin 2 countries
Study dates
16 Jun 2015to 9 Aug 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

427 sites in 2 countries.

320 sites in 2 countries

United States300 sites

  • Investigational Site Number 840481

    Albany, New York, 12206

  • Investigational Site Number 840117

    Alpena, Michigan, 49707

  • Investigational Site Number 840292

    Altoona, Pennsylvania, 16602

  • Investigational Site Number 840213

    Amarillo, Texas, 79106

  • Investigational Site Number 840772

    Amityville, New York, 11701

  • Investigational Site Number 840491

    Anderson, South Carolina, 29621

  • Investigational Site Number 840214

    Asheville, North Carolina, 28803

  • Investigational Site Number 840801

    Ashland, Kentucky, 41101

  • Investigational Site Number 840261

    Atlanta, Georgia, 30328

  • Investigational Site Number 840232

    Atlanta, Georgia, 30342

  • Investigational Site Number 840411

    Aurora, Colorado, 80014

  • Investigational Site Number 840643

    Aventura, Florida, 33180

  • Investigational Site Number 840125

    Avon, Indiana, 46123

  • Investigational Site Number 840746

    Babylon, New York, 11702

  • Investigational Site Number 840337

    Bakersfield, California, 93304

  • Investigational Site Number 840534

    Baltimore, Maryland, 21218

  • Investigational Site Number 840387

    Bangor, Maine, 04401

  • Investigational Site Number 840009

    Beaver, Pennsylvania, 15009

  • Investigational Site Number 840103

    Bend, Oregon, 97702

  • Investigational Site Number 840754

    Benton, Kentucky, 42025

  • Investigational Site Number 840753

    Billings, Montana, 59102

  • Investigational Site Number 840731

    Birmingham, Alabama, 35205

  • Investigational Site Number 840305

    Birmingham, Alabama, 35211

  • Investigational Site Number 840811

    Birmingham, Alabama, 35235

  • Investigational Site Number 840400

    Blackfoot, Idaho, 83221

  • Investigational Site Number 840129

    Blue Ridge, Georgia, 30513

  • Investigational Site Number 840652

    Boca Raton, Florida, 33433

  • Investigational Site Number 840764

    Boise, Idaho, 83642

  • Investigational Site Number 840423

    Boston, Massachusetts, 02115

  • Investigational Site Number 840449

    Bradenton, Florida, 34209

  • Investigational Site Number 840302

    Bridgeton, Missouri, 63044

  • Investigational Site Number 840717

    Bristol, Tennessee, 37620

  • Investigational Site Number 840355

    Brooklyn, New York, 11215

  • Investigational Site Number 840136

    Brooklyn, New York

  • Investigational Site Number 840344

    Brownsburg, Indiana, 46112

  • Investigational Site Number 840237

    Burlington, North Carolina, 27215

  • Investigational Site Number 840714

    Burlington, North Carolina, 27215

  • Investigational Site Number 840603

    Butte, Montana, 59701

  • Investigational Site Number 840077

    Canal Fulton, Ohio, 44614

  • Investigational Site Number 840738

    Canton, Ohio, 44718

  • Investigational Site Number 840455

    Catonsville, Maryland, 21228

  • Investigational Site Number 840658

    Charleston, West Virginia, 25304

  • Investigational Site Number 840456

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840580

    Chatham, Virginia, 24541

  • Investigational Site Number 840160

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840590

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840693

    Chesterfield, Missouri, 63017

  • Investigational Site Number 840005

    Chicago, Illinois, 60607

  • Investigational Site Number 840399

    Chicago, Illinois, 60607

  • Investigational Site Number 840064

    Cincinnati, Ohio, 45212

  • Investigational Site Number 840701

    Cincinnati, Ohio, 45242

  • Investigational Site Number 840779

    Cleveland, Ohio, 44113

  • Investigational Site Number 840392

    Clinton, Utah, 84015

  • Investigational Site Number 840820

    Columbus, Georgia, 31904

  • Investigational Site Number 840380

    Columbus, Ohio, 43201

  • Investigational Site Number 840339

    Columbus, Ohio, 43203

  • Investigational Site Number 840063

    Columbus, Ohio, 43207

  • Investigational Site Number 840191

    Columbus, Ohio, 43207

  • Investigational Site Number 840752

    Columbus, Ohio, 43213

  • Investigational Site Number 840312

    Concord, North Carolina, 28025

  • Investigational Site Number 840725

    Conway, Arkansas, 72034

  • Investigational Site Number 840081

    Cooper City, Florida, 33024

  • Investigational Site Number 840027

    Coral Gables, Florida, 33134

  • Investigational Site Number 840446

    Coral Gables, Florida, 33134

  • Investigational Site Number 840157

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840686

    Council Bluffs, Iowa, 51501

  • Investigational Site Number 840342

    Covington, Kentucky, 41011

  • Investigational Site Number 840592

    Covington, Louisiana, 70433

  • Investigational Site Number 840744

    Covington, Louisiana, 70433

  • Investigational Site Number 840532

    Crowley, Louisiana, 70526

  • Investigational Site Number 840407

    Cutler Bay, Florida, 33157

  • Investigational Site Number 840011

    Dallas, Texas, 75218

  • Investigational Site Number 840313

    Dallas, Texas, 75218

  • Investigational Site Number 840013

    Dallas, Texas, 75231

  • Investigational Site Number 840034

    Dallas, Texas, 75231

  • Investigational Site Number 840333

    Dallas, Texas, 75235

  • Investigational Site Number 840405

    Dallas, Texas, 75254

  • Investigational Site Number 840788

    Danville, Virginia, 24540

  • Investigational Site Number 840706

    Danville, Virginia, 24541

  • Investigational Site Number 840736

    Danville, Virginia, 24541

  • Investigational Site Number 840767

    Decatur, Georgia, 30034

  • Investigational Site Number 840812

    Decatur, Georgia, 30035

  • Investigational Site Number 840596

    Denver, Colorado, 80209

  • Investigational Site Number 840170

    Denver, Colorado, 80246

  • Investigational Site Number 840175

    Des Moines, Iowa, 50134

  • Investigational Site Number 840289

    Detroit, Michigan, 48235

  • Investigational Site Number 840083

    Doral, Florida, 33122

  • Investigational Site Number 840059

    Downingtown, Pennsylvania, 19335

  • Investigational Site Number 840700

    Dunwoody, Georgia, 30338

  • Investigational Site Number 840648

    East Point, Georgia, 30344

  • Investigational Site Number 840799

    Edison, New Jersey, 08837

  • Investigational Site Number 840262

    Edmond, Oklahoma, 73034

  • Investigational Site Number 840089

    El Cajon, California, 92020

  • Investigational Site Number 840330

    El Paso, Texas, 79925

  • Investigational Site Number 840301

    Elgin, Illinois, 60124

  • Investigational Site Number 840713

    Elizabethtown, Kentucky, 42701

  • Investigational Site Number 840264

    Elkhorn, Nebraska, 68022

  • Investigational Site Number 840684

    Elyria, Ohio, 44035

  • Investigational Site Number 840188

    Englewood, Colorado, 80113

  • Investigational Site Number 840024

    Escondido, California, 92025

  • Investigational Site Number 840053

    Essexville, Michigan, 48732

  • Investigational Site Number 840007

    Evansville, Indiana, 47714

  • Investigational Site Number 840164

    Evansville, Indiana, 47714

  • Investigational Site Number 840324

    Evansville, Indiana, 47715

  • Investigational Site Number 840709

    Everett, Washington, 98208

  • Investigational Site Number 840545

    Fargo, North Dakota, 58104

  • Investigational Site Number 840238

    Federal Way, Washington, 98003-8708

  • Investigational Site Number 840663

    Findlay, Ohio, 45840

  • Investigational Site Number 840181

    Fleetwood, Pennsylvania, 19522

  • Investigational Site Number 840141

    Fleming Island, Florida, 32003

  • Investigational Site Number 840150

    Flint, Michigan, 48504

  • Investigational Site Number 840184

    Flint, Michigan, 48532

  • Investigational Site Number 840734

    Forest Hills, New York, 11375

  • Investigational Site Number 840035

    Fort Lauderdale, Florida, 33316

  • Investigational Site Number 840068

    Fort Lauderdale, Florida, 33316

  • Investigational Site Number 840307

    Fort Worth, Texas, 76104

  • Investigational Site Number 840022

    Franklin, Indiana, 46131

  • Investigational Site Number 840379

    Franklin, Ohio, 45005

  • Investigational Site Number 840794

    Franklin, Tennessee, 37064

  • Investigational Site Number 840575

    Fredericksburg, Virginia, 22408

  • Investigational Site Number 840020

    Fresno, California, 93721

  • Investigational Site Number 840126

    Gallipolis, Ohio, 45631

  • Investigational Site Number 840659

    Great Neck, New York, 11367

  • Investigational Site Number 840536

    Greenfield, Indiana, 46140

  • Investigational Site Number 840763

    Greensboro, North Carolina, 27401

  • Investigational Site Number 840611

    Greensboro, North Carolina, 27405

  • Investigational Site Number 840776

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840743

    Greensburg, Pennsylvania, 15601

  • Investigational Site Number 840361

    Greenville, North Carolina, 27834

  • Investigational Site Number 840732

    Greenville, South Carolina, 29601

  • Investigational Site Number 840043

    Greer, South Carolina, 29651

  • Investigational Site Number 840218

    Gulf Shores, Alabama, 36542

  • Investigational Site Number 840739

    Guntersville, Alabama, 35976

  • Investigational Site Number 840760

    Hammond, Louisiana, 70403

  • Investigational Site Number 840662

    Hampton, Virginia, 23666

  • Investigational Site Number 840294

    Henderson, Nevada, 89014

  • Investigational Site Number 840087

    Henderson, Nevada, 89052

  • Investigational Site Number 840145

    Hialeah, Florida, 33016

  • Investigational Site Number 840705

    High Point, North Carolina, 27262

  • Investigational Site Number 840644

    Holbrook, New York, 11741

  • Investigational Site Number 840681

    Hopkinsville, Kentucky, 42240

  • Investigational Site Number 840182

    Houston, Texas, 77008

  • Investigational Site Number 840366

    Houston, Texas, 77024

  • Investigational Site Number 840608

    Houston, Texas, 77043

  • Investigational Site Number 840323

    Houston, Texas, 77053

  • Investigational Site Number 840502

    Houston, Texas, 77070

  • Investigational Site Number 840513

    Houston, Texas, 77070

  • Investigational Site Number 840377

    Houston, Texas, 77079

  • Investigational Site Number 840306

    Houston, Texas, 77083-4436

  • Investigational Site Number 840137

    Houston, Texas, 77090

  • Investigational Site Number 840521

    Houston, Texas, 77090

  • Investigational Site Number 840533

    Houston, Texas, 77095

  • Investigational Site Number 840211

    Houston, Texas, 77099

  • Investigational Site Number 840260

    Humble, Texas, 77338

  • Investigational Site Number 840479

    Huntingdon Valley, Pennsylvania, 19006

  • Investigational Site Number 840367

    Huntsville, Alabama, 35801

  • Investigational Site Number 840470

    Imperial, California, 92251

  • Investigational Site Number 840712

    Indiana, Pennsylvania, 15701

  • Investigational Site Number 840582

    Indianapolis, Indiana, 46254

  • Investigational Site Number 840155

    Inglewood, California, 90301

  • Investigational Site Number 840161

    Inglewood, California, 90301

  • Investigational Site Number 840403

    Irving, Texas, 75039

  • Investigational Site Number 840171

    Jackson, Tennessee, 38305

  • Investigational Site Number 840550

    Jackson, Tennessee, 38305

  • Investigational Site Number 840142

    Jacksonville, Florida, 322078334

  • Investigational Site Number 840352

    Jacksonville, Florida, 32216

  • Investigational Site Number 840159

    Jamaica, New York, 11432

  • Investigational Site Number 840041

    Jefferson City, Missouri, 65109

  • Investigational Site Number 840402

    Joliet, Illinois, 60435

  • Investigational Site Number 840790

    Jonesboro, Arkansas, 72401

  • Investigational Site Number 840021

    Jupiter, Florida, 33458

  • Investigational Site Number 840236

    Kalamazoo, Michigan, 49009

  • Investigational Site Number 840771

    Kettering, Ohio, 45429

  • Investigational Site Number 840132

    Kingsport, Tennessee, 37660

  • Investigational Site Number 840639

    Kissimmee, Florida, 34741

  • Investigational Site Number 840640

    Kissimmee, Florida, 34741

  • Investigational Site Number 840140

    Knoxville, Tennessee, 37912

  • Investigational Site Number 840194

    Laguna Hills, California, 92653

  • Investigational Site Number 840710

    Laguna Hills, California, 92653

  • Investigational Site Number 840463

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 840777

    Lake Clarke Shores, Florida, 33406

  • Investigational Site Number 840148

    Lake Success, New York, 11042

  • Investigational Site Number 840382

    Lampasas, Texas, 76550

  • Investigational Site Number 840204

    Lancaster, California, 93534

  • Investigational Site Number 840257

    Lancaster, Ohio, 43130

  • Investigational Site Number 840523

    Lansdale, Pennsylvania, 19446

  • Investigational Site Number 840664

    Las Vegas, Nevada, 89101

  • Investigational Site Number 840108

    Las Vegas, Nevada, 89106

  • Investigational Site Number 840412

    Las Vegas, Nevada, 89109

  • Investigational Site Number 840656

    Las Vegas, Nevada, 89117

  • Investigational Site Number 840638

    Las Vegas, Nevada, 89118

  • Investigational Site Number 840750

    Las Vegas, Nevada, 89121

  • Investigational Site Number 840815

    Las Vegas, Nevada, 89144

  • Investigational Site Number 840253

    Laurelton, New York, 11422

  • Investigational Site Number 840110

    Lawrenceville, Georgia

  • Investigational Site Number 840766

    Levittown, Pennsylvania, 19056

  • Investigational Site Number 840595

    Lewisburg, West Virginia, 24901

  • Investigational Site Number 840755

    Lexington, North Carolina, 27292

  • Investigational Site Number 840167

    Linden, New Jersey, 07036

  • Investigational Site Number 840699

    Little Rock, Arkansas, 72204

  • Investigational Site Number 840528

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840329

    Littleton, Colorado, 80127

  • Investigational Site Number 840728

    Littleton, Colorado, 80128

  • Investigational Site Number 840371

    Los Angeles, California, 90017

  • Investigational Site Number 840310

    Los Angeles, California, 90036

  • Investigational Site Number 840504

    Los Angeles, California, 90036

  • Investigational Site Number 840340

    Los Angeles, California, 90057

  • Investigational Site Number 840309

    Los Gatos, California, 95032

  • Investigational Site Number 840578

    Louisville, Kentucky, 40202

  • Investigational Site Number 840680

    Lubbock, Texas, 79423

  • Investigational Site Number 840795

    Lynchburg, Virginia, 24501

  • Investigational Site Number 840584

    Lyndhurst, Ohio, 44124

  • Investigational Site Number 840444

    Macon, Georgia, 31210

  • Investigational Site Number 840362

    Margate, Florida, 33063

  • Investigational Site Number 840003

    Marietta, Georgia, 30067

  • Investigational Site Number 840165

    Marion, Ohio, 43302

  • Investigational Site Number 840675

    Marrero, Louisiana, 70072

  • Investigational Site Number 840605

    Martinsville, Virginia, 24112

  • Investigational Site Number 840308

    McAllen, Texas, 78503

  • Investigational Site Number 840625

    Memphis, Tennessee, 38119

  • Investigational Site Number 840789

    Merrick, New York, 11566

  • Investigational Site Number 840549

    Mesquite, Texas, 75149

  • Investigational Site Number 840133

    Metairie, Louisiana, 70006

  • Investigational Site Number 840002

    Miami, Florida, 33015

  • Investigational Site Number 840012

    Miami, Florida, 33126

  • Investigational Site Number 840698

    Miami, Florida, 33126

  • Investigational Site Number 840102

    Miami, Florida, 33136

  • Investigational Site Number 840209

    Miami, Florida, 33142

  • Investigational Site Number 840014

    Miami, Florida, 33144

  • Investigational Site Number 840128

    Miami, Florida, 33155

  • Investigational Site Number 840143

    Miami, Florida, 33155

  • Investigational Site Number 840349

    Miami, Florida, 33155

  • Investigational Site Number 840758

    Miami, Florida, 33155

  • Investigational Site Number 840690

    Miami, Florida, 33166

  • Investigational Site Number 840415

    Miami, Florida, 33174

  • Investigational Site Number 840197

    Miami, Florida, 33185

  • Investigational Site Number 840414

    Miami, Florida, 33189

  • Investigational Site Number 840221

    Miami Lakes, Florida, 33016

  • Investigational Site Number 840303

    Miami Lakes, Florida, 33326

  • Investigational Site Number 840800

    Miamisburg, Ohio, 45342

  • Investigational Site Number 840694

    Michigan City, Indiana, 46360

  • Investigational Site Number 840360

    Midwest City, Oklahoma, 73110

  • Investigational Site Number 840351

    Missouri City, Texas, 77459

  • Investigational Site Number 840622

    Monroe, Louisiana, 71203

  • Investigational Site Number 840130

    Montgomery, Alabama, 36104

  • Investigational Site Number 840729

    Montgomery, Alabama, 36109

  • Investigational Site Number 840688

    Mooresville, North Carolina, 28117

  • Investigational Site Number 840747

    Mooresville, North Carolina, 28117

  • Investigational Site Number 840296

    Morganton, North Carolina, 28655

  • Investigational Site Number 840226

    Morton, Illinois, 61550

  • Investigational Site Number 840052

    Muncie, Indiana, 47304

  • Investigational Site Number 840109

    Murrells Inlet, South Carolina, 29576

  • Investigational Site Number 840144

    Nashua, New Hampshire, 03063-4068

  • Investigational Site Number 840299

    Nashville, Tennessee, 37203

  • Investigational Site Number 840147

    Natchitoches, Louisiana, 71457

  • Investigational Site Number 840060

    Neptune City, New Jersey, 07753

  • Investigational Site Number 840716

    Nesconset, New York, 11767

  • Investigational Site Number 840786

    New Albany, Indiana, 47150

  • Investigational Site Number 840573

    New Bern, North Carolina, 28562

  • Investigational Site Number 840810

    New Hyde Park, New York, 11040

  • Investigational Site Number 840072

    New Hyde Park, New York, 11042

  • Investigational Site Number 840609

    New Orleans, Louisiana, 70115

  • Investigational Site Number 840381

    New Tazewell, Tennessee, 37825

  • Investigational Site Number 840674

    New Windsor, New York, 12553

  • Investigational Site Number 840626

    New York, New York, 10001

  • Investigational Site Number 840586

    New York, New York, 10128

  • Investigational Site Number 840620

    Newport News, Virginia, 23606

  • Investigational Site Number 840088

    Norfolk, Virginia

  • Investigational Site Number 840247

    North Chesterfield, Virginia, 11042

  • Investigational Site Number 840256

    North Hollywood, California, 91606

  • Investigational Site Number 840044

    North Massapequa, New York, 11758-1802

  • Investigational Site Number 840327

    North Myrtle Beach, South Carolina, 29582

  • Investigational Site Number 840687

    Northglenn, Colorado, 80234

  • Investigational Site Number 840015

    Northridge, California, 91325

  • Investigational Site Number 840056

    Norwalk, California, 90650

  • Investigational Site Number 840508

    Ocala, Florida, 34471

  • Investigational Site Number 840092

    Ocoee, Florida, 34761

  • Investigational Site Number 840363

    Oklahoma City, Oklahoma, 73104

  • Investigational Site Number 840556

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 840033

    Olive Branch, Mississippi, 38654

  • Investigational Site Number 840742

    Omaha, Nebraska, 68144

  • Investigational Site Number 840090

    Orange, California, 92868

  • Investigational Site Number 840478

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840576

    Owensboro, Kentucky, 42303

  • Investigational Site Number 840819

    Owensboro, Kentucky, 42320

  • Investigational Site Number 840373

    Palestine, Texas, 75801

  • Investigational Site Number 840118

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840078

    Palm Springs, California, 92262

  • Investigational Site Number 840791

    Palmdale, California, 93551

  • Investigational Site Number 840080

    Panama City, Florida, 32401

  • Investigational Site Number 840216

    Paramount, California, 90723

  • Investigational Site Number 840645

    Paris, Kentucky, 40361

  • Investigational Site Number 840032

    Penndel, Pennsylvania, 19047

  • Investigational Site Number 840730

    Pennington Gap, Virginia, 24277

  • Investigational Site Number 840318

    Peoria, Illinois, 61602

  • Investigational Site Number 840365

    Pharr, Texas, 78577

  • Investigational Site Number 840067

    Philadelphia, Pennsylvania, 19102

  • Investigational Site Number 840277

    Philadelphia, Pennsylvania, 19107

  • Investigational Site Number 840561

    Philadelphia, Pennsylvania, 19114

  • Investigational Site Number 840174

    Philadelphia, Pennsylvania, 19146

Other trials in United States

Canada20 sites

  • Investigational Site Number 124002

    Barrie, L4N4L3

  • Investigational Site Number 124005

    Brampton, L6S0C9

  • Investigational Site Number 124001

    Brampton, L6T4V3

  • Investigational Site Number 124030

    Burlington, L7R1A4

  • Investigational Site Number 124017

    Calgary, T2H2G4

  • Investigational Site Number 124013

    Concord, L4K4M2

  • Investigational Site Number 124018

    Etobicoke, M9R4E1

  • Investigational Site Number 124014

    Etobicoke, M9V4V4

  • Investigational Site Number 124026

    Guelph, N1H1B1

  • Investigational Site Number 124008

    Hamilton, L8K3P3

  • Investigational Site Number 124027

    Hamilton, L8L5G8

  • Investigational Site Number 124010

    London, N5W 6A2

  • Investigational Site Number 124015

    Markham, L6B0P9

  • Investigational Site Number 124020

    Montreal, H2R1V6

  • Investigational Site Number 124016

    Newmarket

  • Investigational Site Number 124024

    Oakville, L6M1M1

  • Investigational Site Number 124029

    Saint-Laurent, H4T1Z9

  • Investigational Site Number 124007

    Surrey, V4A1R6

  • Investigational Site Number 124003

    Toronto, M4G3E8

  • Investigational Site Number 124025

    Vancouver, V5X0C4

Other trials in Canada

About this study

Official title: A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

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.

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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.
Read the 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.

Being tested
Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml, Insulin detemir, Background Therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine, 300 U/mlDrug

    Also called Toujeo

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Insulin glargine, 100 U/mlDrug

    Also called Lantus

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Insulin detemirDrug

    Also called Levemir

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Background TherapyDrug

    Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.

Study groups in NCT02451137
Study groupRoleWhat they receive
ToujeoExperimentalToujeo® (Insulin glargine, 300 units per millilitre [U/mL]) subcutaneous (SC) injection once daily up to Month 12, with or without available participant support program.
Receives: Drug: Insulin glargine, 300 U/ml; Drug: Background Therapy
Standard of CareActive 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.
Receives: Drug: Insulin glargine, 100 U/ml; Drug: Insulin detemir; Drug: Background Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to Month 6

Secondary outcomes (12)

  1. Change From Baseline in HbA1c at Month 6 and 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.

    Measured: Baseline, Month 6, Month 12

  2. Treatment Persistence Measured by Medication Possession Ratio (MPR)

    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.

    Measured: At Month 6 and Month 12

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

    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).

    Measured: Baseline to Month 6

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

    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).

    Measured: Baseline to Month 12

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

    Measured: Baseline, Month 6, Month 12

  6. Change From Baseline in Body Weight at Month 6 and 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.

    Measured: Baseline, Month 6, Month 12

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

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

    Measured: Baseline, Month 6, Month 12

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

    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.

    Measured: At Month 6, Month 12

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

    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.

    Measured: At Baseline, Month 6, Month 12

  10. Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) 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).

    Measured: At Month 12

  11. Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits 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.

    Measured: From Baseline to Month 6 and Month 12

  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

    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).

    Measured: Up to Month 6 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2015 (estimated)
  2. Study start16 Jun 2015
  3. Primary completion2 Mar 2018
  4. Study completion9 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02451137
Sponsor's protocol ID
LPS14347
Other IDs
U1111-1168-0354
Status last verified
Aug 2019
First submitted
19 May 2015
Last updated
10 Sep 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 33509703

  • Oster 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.

    PubMed 27690710

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine, 300 U/ml, Insulin glargine, 100 U/ml and Insulin detemir in people with Diabetes Mellitus, Type 2, run by Sanofi at 427 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 427 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451137, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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