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

NCT ID: NCT02451137

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-16
• Study Completion Date: 2018-08-09

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin glargine, 300 U/ml

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Background Therapy

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Insulin glargine, 100 U/ml

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Insulin detemir

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Background Therapy

Intervention Type: DRUG

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

Interventions

Insulin glargine, 300 U/ml

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine, 100 U/ml

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin detemir

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Background Therapy

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

Intervention Type: DRUG

Other Intervention Names

Toujeo; Lantus; Levemir

Eligibility Criteria

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840731

Birmingham, Alabama, United States

Investigational Site Number 840305

Birmingham, Alabama, United States

Investigational Site Number 840811

Birmingham, Alabama, United States

Investigational Site Number 840218

Gulf Shores, Alabama, United States

Investigational Site Number 840739

Guntersville, Alabama, United States

Investigational Site Number 840367

Huntsville, Alabama, United States

Investigational Site Number 840130

Montgomery, Alabama, United States

Investigational Site Number 840729

Montgomery, Alabama, United States

Investigational Site Number 840281

Saraland, Alabama, United States

Investigational Site Number 840613

Sheffield, Alabama, United States

Investigational Site Number 840634

Sheffield, Alabama, United States

Investigational Site Number 840654

Sheffield, Alabama, United States

Investigational Site Number 840173

Phoenix, Arizona, United States

Investigational Site Number 840555

Phoenix, Arizona, United States

Investigational Site Number 840805

Sun City, Arizona, United States

Investigational Site Number 840725

Conway, Arkansas, United States

Investigational Site Number 840790

Jonesboro, Arkansas, United States

Investigational Site Number 840699

Little Rock, Arkansas, United States

Investigational Site Number 840528

Little Rock, Arkansas, United States

Investigational Site Number 840079

Searcy, Arkansas, United States

Investigational Site Number 840337

Bakersfield, California, United States

Investigational Site Number 840089

El Cajon, California, United States

Investigational Site Number 840024

Escondido, California, United States

Investigational Site Number 840020

Fresno, California, United States

Investigational Site Number 840470

Imperial, California, United States

Investigational Site Number 840155

Inglewood, California, United States

Investigational Site Number 840161

Inglewood, California, United States

Investigational Site Number 840194

Laguna Hills, California, United States

Investigational Site Number 840710

Laguna Hills, California, United States

Investigational Site Number 840204

Lancaster, California, United States

Investigational Site Number 840371

Los Angeles, California, United States

Investigational Site Number 840310

Los Angeles, California, United States

Investigational Site Number 840504

Los Angeles, California, United States

Investigational Site Number 840340

Los Angeles, California, United States

Investigational Site Number 840309

Los Gatos, California, United States

Investigational Site Number 840256

North Hollywood, California, United States

Investigational Site Number 840015

Northridge, California, United States

Investigational Site Number 840056

Norwalk, California, United States

Investigational Site Number 840090

Orange, California, United States

Investigational Site Number 840078

Palm Springs, California, United States

Investigational Site Number 840791

Palmdale, California, United States

Investigational Site Number 840216

Paramount, California, United States

Investigational Site Number 840413

Pomona, California, United States

Investigational Site Number 840244

Port Hueneme, California, United States

Investigational Site Number 840162

San Diego, California, United States

Investigational Site Number 840028

San Diego, California, United States

Investigational Site Number 840383

San Dimas, California, United States

Investigational Site Number 840627

San Jose, California, United States

Investigational Site Number 840120

San Ramon, California, United States

Investigational Site Number 840156

Santa Ana, California, United States

Investigational Site Number 840266

Sherman Oaks, California, United States

Investigational Site Number 840091

Sylmar, California, United States

Investigational Site Number 840208

Thousand Oaks, California, United States

Investigational Site Number 840115

Torrance, California, United States

Investigational Site Number 840792

Torrance, California, United States

Investigational Site Number 840612

Tulare, California, United States

Investigational Site Number 840467

Upland, California, United States

Investigational Site Number 840185

Vista, California, United States

Investigational Site Number 840472

Whittier, California, United States

Investigational Site Number 840411

Aurora, Colorado, United States

Investigational Site Number 840596

Denver, Colorado, United States

Investigational Site Number 840170

Denver, Colorado, United States

Investigational Site Number 840188

Englewood, Colorado, United States

Investigational Site Number 840329

Littleton, Colorado, United States

Investigational Site Number 840728

Littleton, Colorado, United States

Investigational Site Number 840687

Northglenn, Colorado, United States

Investigational Site Number 840643

Aventura, Florida, United States

Investigational Site Number 840652

Boca Raton, Florida, United States

Investigational Site Number 840449

Bradenton, Florida, United States

Investigational Site Number 840081

Cooper City, Florida, United States

Investigational Site Number 840027

Coral Gables, Florida, United States

Investigational Site Number 840446

Coral Gables, Florida, United States

Investigational Site Number 840407

Cutler Bay, Florida, United States

Investigational Site Number 840083

Doral, Florida, United States

Investigational Site Number 840141

Fleming Island, Florida, United States

Investigational Site Number 840035

Fort Lauderdale, Florida, United States

Investigational Site Number 840068

Fort Lauderdale, Florida, United States

Investigational Site Number 840145

Hialeah, Florida, United States

Investigational Site Number 840142

Jacksonville, Florida, United States

Investigational Site Number 840352

Jacksonville, Florida, United States

Investigational Site Number 840021

Jupiter, Florida, United States

Investigational Site Number 840639

Kissimmee, Florida, United States

Investigational Site Number 840640

Kissimmee, Florida, United States

Investigational Site Number 840777

Lake Clarke Shores, Florida, United States

Investigational Site Number 840362

Margate, Florida, United States

Investigational Site Number 840002

Miami, Florida, United States

Investigational Site Number 840012

Miami, Florida, United States

Investigational Site Number 840698

Miami, Florida, United States

Investigational Site Number 840102

Miami, Florida, United States

Investigational Site Number 840209

Miami, Florida, United States

Investigational Site Number 840014

Miami, Florida, United States

Investigational Site Number 840128

Miami, Florida, United States

Investigational Site Number 840143

Miami, Florida, United States

Investigational Site Number 840349

Miami, Florida, United States

Investigational Site Number 840758

Miami, Florida, United States

Investigational Site Number 840690

Miami, Florida, United States

Investigational Site Number 840415

Miami, Florida, United States

Investigational Site Number 840197

Miami, Florida, United States

Investigational Site Number 840414

Miami, Florida, United States

Investigational Site Number 840221

Miami Lakes, Florida, United States

Investigational Site Number 840303

Miami Lakes, Florida, United States

Investigational Site Number 840508

Ocala, Florida, United States

Investigational Site Number 840092

Ocoee, Florida, United States

Investigational Site Number 840118

Palm Harbor, Florida, United States

Investigational Site Number 840080

Panama City, Florida, United States

Investigational Site Number 840372

Plantation, Florida, United States

Investigational Site Number 840199

Port Charlotte, Florida, United States

Investigational Site Number 840538

Winter Haven, Florida, United States

Investigational Site Number 840261

Atlanta, Georgia, United States

Investigational Site Number 840232

Atlanta, Georgia, United States

Investigational Site Number 840129

Blue Ridge, Georgia, United States

Investigational Site Number 840820

Columbus, Georgia, United States

Investigational Site Number 840767

Decatur, Georgia, United States

Investigational Site Number 840812

Decatur, Georgia, United States

Investigational Site Number 840700

Dunwoody, Georgia, United States

Investigational Site Number 840648

East Point, Georgia, United States

Investigational Site Number 840110

Lawrenceville, Georgia, United States

Investigational Site Number 840444

Macon, Georgia, United States

Investigational Site Number 840003

Marietta, Georgia, United States

Investigational Site Number 840632

Sandersville, Georgia, United States

Investigational Site Number 840616

Savannah, Georgia, United States

Investigational Site Number 840591

Savannah, Georgia, United States

Investigational Site Number 840727

Smyrna, Georgia, United States

Investigational Site Number 840520

Snellville, Georgia, United States

Investigational Site Number 840163

Statesboro, Georgia, United States

Investigational Site Number 840297

Stockbridge, Georgia, United States

Investigational Site Number 840715

Thomson, Georgia, United States

Investigational Site Number 840400

Blackfoot, Idaho, United States

Investigational Site Number 840764

Boise, Idaho, United States

Investigational Site Number 840005

Chicago, Illinois, United States

Investigational Site Number 840399

Chicago, Illinois, United States

Investigational Site Number 840301

Elgin, Illinois, United States

Investigational Site Number 840402

Joliet, Illinois, United States

Investigational Site Number 840226

Morton, Illinois, United States

Investigational Site Number 840318

Peoria, Illinois, United States

Investigational Site Number 840125

Avon, Indiana, United States

Investigational Site Number 840344

Brownsburg, Indiana, United States

Investigational Site Number 840007

Evansville, Indiana, United States

Investigational Site Number 840164

Evansville, Indiana, United States

Investigational Site Number 840324

Evansville, Indiana, United States

Investigational Site Number 840022

Franklin, Indiana, United States

Investigational Site Number 840536

Greenfield, Indiana, United States

Investigational Site Number 840582

Indianapolis, Indiana, United States

Investigational Site Number 840694

Michigan City, Indiana, United States

Investigational Site Number 840052

Muncie, Indiana, United States

Investigational Site Number 840786

New Albany, Indiana, United States

Investigational Site Number 840686

Council Bluffs, Iowa, United States

Investigational Site Number 840175

Des Moines, Iowa, United States

Investigational Site Number 840466

West Des Moines, Iowa, United States

Investigational Site Number 840134

Topeka, Kansas, United States

Investigational Site Number 840801

Ashland, Kentucky, United States

Investigational Site Number 840754

Benton, Kentucky, United States

Investigational Site Number 840342

Covington, Kentucky, United States

Investigational Site Number 840713

Elizabethtown, Kentucky, United States

Investigational Site Number 840681

Hopkinsville, Kentucky, United States

Investigational Site Number 840578

Louisville, Kentucky, United States

Investigational Site Number 840478

Owensboro, Kentucky, United States

Investigational Site Number 840576

Owensboro, Kentucky, United States

Investigational Site Number 840819

Owensboro, Kentucky, United States

Investigational Site Number 840645

Paris, Kentucky, United States

Investigational Site Number 840741

Versailles, Kentucky, United States

Investigational Site Number 840592

Covington, Louisiana, United States

Investigational Site Number 840744

Covington, Louisiana, United States

Investigational Site Number 840532

Crowley, Louisiana, United States

Investigational Site Number 840760

Hammond, Louisiana, United States

Investigational Site Number 840463

Lake Charles, Louisiana, United States

Investigational Site Number 840675

Marrero, Louisiana, United States

Investigational Site Number 840133

Metairie, Louisiana, United States

Investigational Site Number 840622

Monroe, Louisiana, United States

Investigational Site Number 840147

Natchitoches, Louisiana, United States

Investigational Site Number 840609

New Orleans, Louisiana, United States

Investigational Site Number 840311

Shreveport, Louisiana, United States

Investigational Site Number 840619

Slidell, Louisiana, United States

Investigational Site Number 840673

Zachary, Louisiana, United States

Investigational Site Number 840387

Bangor, Maine, United States

Investigational Site Number 840689

Portland, Maine, United States

Investigational Site Number 840534

Baltimore, Maryland, United States

Investigational Site Number 840455

Catonsville, Maryland, United States

Investigational Site Number 840393

Rockville, Maryland, United States

Investigational Site Number 840423

Boston, Massachusetts, United States

Investigational Site Number 840117

Alpena, Michigan, United States

Investigational Site Number 840289

Detroit, Michigan, United States

Investigational Site Number 840053

Essexville, Michigan, United States

Investigational Site Number 840150

Flint, Michigan, United States

Investigational Site Number 840184

Flint, Michigan, United States

Investigational Site Number 840236

Kalamazoo, Michigan, United States

Investigational Site Number 840210

Southfield, Michigan, United States

Investigational Site Number 840258

Stevensville, Michigan, United States

Investigational Site Number 840158

Troy, Michigan, United States

Investigational Site Number 840524

Troy, Michigan, United States

Investigational Site Number 840033

Olive Branch, Mississippi, United States

Investigational Site Number 840302

Bridgeton, Missouri, United States

Investigational Site Number 840693

Chesterfield, Missouri, United States

Investigational Site Number 840041

Jefferson City, Missouri, United States

Investigational Site Number 840711

St Louis, Missouri, United States

Investigational Site Number 840753

Billings, Montana, United States

Investigational Site Number 840603

Butte, Montana, United States

Investigational Site Number 840264

Elkhorn, Nebraska, United States

Investigational Site Number 840742

Omaha, Nebraska, United States

Investigational Site Number 840294

Henderson, Nevada, United States

Investigational Site Number 840087

Henderson, Nevada, United States

Investigational Site Number 840664

Las Vegas, Nevada, United States

Investigational Site Number 840108

Las Vegas, Nevada, United States

Investigational Site Number 840412

Las Vegas, Nevada, United States

Investigational Site Number 840656

Las Vegas, Nevada, United States

Investigational Site Number 840638

Las Vegas, Nevada, United States

Investigational Site Number 840750

Las Vegas, Nevada, United States

Investigational Site Number 840815

Las Vegas, Nevada, United States

Investigational Site Number 840761

Reno, Nevada, United States

Investigational Site Number 840144

Nashua, New Hampshire, United States

Investigational Site Number 840799

Edison, New Jersey, United States

Investigational Site Number 840167

Linden, New Jersey, United States

Investigational Site Number 840060

Neptune City, New Jersey, United States

Investigational Site Number 840679

Sicklerville, New Jersey, United States

Investigational Site Number 840559

Teaneck, New Jersey, United States

Investigational Site Number 840481

Albany, New York, United States

Investigational Site Number 840772

Amityville, New York, United States

Investigational Site Number 840746

Babylon, New York, United States

Investigational Site Number 840355

Brooklyn, New York, United States

Investigational Site Number 840136

Brooklyn, New York, United States

Investigational Site Number 840734

Forest Hills, New York, United States

Investigational Site Number 840659

Great Neck, New York, United States

Investigational Site Number 840644

Holbrook, New York, United States

Investigational Site Number 840159

Jamaica, New York, United States

Investigational Site Number 840148

Lake Success, New York, United States

Investigational Site Number 840253

Laurelton, New York, United States

Investigational Site Number 840789

Merrick, New York, United States

Investigational Site Number 840716

Nesconset, New York, United States

Investigational Site Number 840810

New Hyde Park, New York, United States

Investigational Site Number 840072

New Hyde Park, New York, United States

Investigational Site Number 840674

New Windsor, New York, United States

Investigational Site Number 840626

New York, New York, United States

Investigational Site Number 840586

New York, New York, United States

Investigational Site Number 840044

North Massapequa, New York, United States

Investigational Site Number 840587

Smithtown, New York, United States

Investigational Site Number 840577

Staten Island, New York, United States

Investigational Site Number 840773

Syosset, New York, United States

Investigational Site Number 840047

Yonkers, New York, United States

Investigational Site Number 840214

Asheville, North Carolina, United States

Investigational Site Number 840237

Burlington, North Carolina, United States

Investigational Site Number 840714

Burlington, North Carolina, United States

Investigational Site Number 840456

Charlotte, North Carolina, United States

Investigational Site Number 840312

Concord, North Carolina, United States

Investigational Site Number 840763

Greensboro, North Carolina, United States

Investigational Site Number 840611

Greensboro, North Carolina, United States

Investigational Site Number 840776

Greensboro, North Carolina, United States

Investigational Site Number 840361

Greenville, North Carolina, United States

Investigational Site Number 840705

High Point, North Carolina, United States

Investigational Site Number 840755

Lexington, North Carolina, United States

Investigational Site Number 840688

Mooresville, North Carolina, United States

Investigational Site Number 840747

Mooresville, North Carolina, United States

Investigational Site Number 840296

Morganton, North Carolina, United States

Investigational Site Number 840573

New Bern, North Carolina, United States

Investigational Site Number 840096

Salisbury, North Carolina, United States

Investigational Site Number 840697

Shelby, North Carolina, United States

Investigational Site Number 840636

Wilmington, North Carolina, United States

Investigational Site Number 840195

Wilson, North Carolina, United States

Investigational Site Number 840315

Winston-Salem, North Carolina, United States

Investigational Site Number 840545

Fargo, North Dakota, United States

Investigational Site Number 840077

Canal Fulton, Ohio, United States

Investigational Site Number 840738

Canton, Ohio, United States

Investigational Site Number 840064

Cincinnati, Ohio, United States

Investigational Site Number 840701

Cincinnati, Ohio, United States

Investigational Site Number 840779

Cleveland, Ohio, United States

Investigational Site Number 840380

Columbus, Ohio, United States

Investigational Site Number 840339

Columbus, Ohio, United States

Investigational Site Number 840063

Columbus, Ohio, United States

Investigational Site Number 840191

Columbus, Ohio, United States

Investigational Site Number 840752

Columbus, Ohio, United States

Investigational Site Number 840684

Elyria, Ohio, United States

Investigational Site Number 840663

Findlay, Ohio, United States

Investigational Site Number 840379

Franklin, Ohio, United States

Investigational Site Number 840126

Gallipolis, Ohio, United States

Investigational Site Number 840771

Kettering, Ohio, United States

Investigational Site Number 840257

Lancaster, Ohio, United States

Investigational Site Number 840584

Lyndhurst, Ohio, United States

Investigational Site Number 840165

Marion, Ohio, United States

Investigational Site Number 840800

Miamisburg, Ohio, United States

Investigational Site Number 840560

Tallmadge, Ohio, United States

Investigational Site Number 840515

Toledo, Ohio, United States

Investigational Site Number 840797

Vandalia, Ohio, United States

Investigational Site Number 840192

Wadsworth, Ohio, United States

Investigational Site Number 840389

Willoughby Hills, Ohio, United States

Investigational Site Number 840751

Wooster, Ohio, United States

Investigational Site Number 840262

Edmond, Oklahoma, United States

Investigational Site Number 840360

Midwest City, Oklahoma, United States

Investigational Site Number 840363

Oklahoma City, Oklahoma, United States

Investigational Site Number 840556

Oklahoma City, Oklahoma, United States

Investigational Site Number 840103

Bend, Oregon, United States

Investigational Site Number 840292

Altoona, Pennsylvania, United States

Investigational Site Number 840009

Beaver, Pennsylvania, United States

Investigational Site Number 840059

Downingtown, Pennsylvania, United States

Investigational Site Number 840181

Fleetwood, Pennsylvania, United States

Investigational Site Number 840743

Greensburg, Pennsylvania, United States

Investigational Site Number 840479

Huntingdon Valley, Pennsylvania, United States

Investigational Site Number 840712

Indiana, Pennsylvania, United States

Investigational Site Number 840523

Lansdale, Pennsylvania, United States

Investigational Site Number 840766

Levittown, Pennsylvania, United States

Investigational Site Number 840032

Penndel, Pennsylvania, United States

Investigational Site Number 840067

Philadelphia, Pennsylvania, United States

Investigational Site Number 840277

Philadelphia, Pennsylvania, United States

Investigational Site Number 840561

Philadelphia, Pennsylvania, United States

Investigational Site Number 840174

Philadelphia, Pennsylvania, United States

Investigational Site Number 840348

Pittsburgh, Pennsylvania, United States

Investigational Site Number 840669

Pottstown, Pennsylvania, United States

Investigational Site Number 840748

Sayre, Pennsylvania, United States

Investigational Site Number 840187

Smithfield, Pennsylvania, United States

Investigational Site Number 840287

Uniontown, Pennsylvania, United States

Investigational Site Number 840341

Uniontown, Pennsylvania, United States

Investigational Site Number 840378

Providence, Rhode Island, United States

Investigational Site Number 840491

Anderson, South Carolina, United States

Investigational Site Number 840732

Greenville, South Carolina, United States

Investigational Site Number 840043

Greer, South Carolina, United States

Investigational Site Number 840109

Murrells Inlet, South Carolina, United States

Investigational Site Number 840327

North Myrtle Beach, South Carolina, United States

Investigational Site Number 840759

Simpsonville, South Carolina, United States

Investigational Site Number 840628

Summerville, South Carolina, United States

Investigational Site Number 840717

Bristol, Tennessee, United States

Investigational Site Number 840160

Chattanooga, Tennessee, United States

Investigational Site Number 840794

Franklin, Tennessee, United States

Investigational Site Number 840171

Jackson, Tennessee, United States

Investigational Site Number 840550

Jackson, Tennessee, United States

Investigational Site Number 840132

Kingsport, Tennessee, United States

Investigational Site Number 840140

Knoxville, Tennessee, United States

Investigational Site Number 840625

Memphis, Tennessee, United States

Investigational Site Number 840299

Nashville, Tennessee, United States

Investigational Site Number 840381

New Tazewell, Tennessee, United States

Investigational Site Number 840213

Amarillo, Texas, United States

Investigational Site Number 840157

Corpus Christi, Texas, United States

Investigational Site Number 840011

Dallas, Texas, United States

Investigational Site Number 840313

Dallas, Texas, United States

Investigational Site Number 840013

Dallas, Texas, United States

Investigational Site Number 840034

Dallas, Texas, United States

Investigational Site Number 840333

Dallas, Texas, United States

Investigational Site Number 840405

Dallas, Texas, United States

Investigational Site Number 840330

El Paso, Texas, United States

Investigational Site Number 840307

Fort Worth, Texas, United States

Investigational Site Number 840182

Houston, Texas, United States

Investigational Site Number 840366

Houston, Texas, United States

Investigational Site Number 840608

Houston, Texas, United States

Investigational Site Number 840323

Houston, Texas, United States

Investigational Site Number 840502

Houston, Texas, United States

Investigational Site Number 840513

Houston, Texas, United States

Investigational Site Number 840377

Houston, Texas, United States

Investigational Site Number 840306

Houston, Texas, United States

Investigational Site Number 840137

Houston, Texas, United States

Investigational Site Number 840521

Houston, Texas, United States

Investigational Site Number 840533

Houston, Texas, United States

Investigational Site Number 840211

Houston, Texas, United States

Investigational Site Number 840260

Humble, Texas, United States

Investigational Site Number 840403

Irving, Texas, United States

Investigational Site Number 840382

Lampasas, Texas, United States

Investigational Site Number 840680

Lubbock, Texas, United States

Investigational Site Number 840308

McAllen, Texas, United States

Investigational Site Number 840549

Mesquite, Texas, United States

Investigational Site Number 840351

Missouri City, Texas, United States

Investigational Site Number 840373

Palestine, Texas, United States

Investigational Site Number 840365

Pharr, Texas, United States

Investigational Site Number 840439

Plano, Texas, United States

Investigational Site Number 840707

Port Arthur, Texas, United States

Investigational Site Number 840692

Richmond, Texas, United States

Investigational Site Number 840431

San Antonio, Texas, United States

Investigational Site Number 840074

San Antonio, Texas, United States

Investigational Site Number 840691

San Antonio, Texas, United States

Investigational Site Number 840176

San Antonio, Texas, United States

Investigational Site Number 840135

San Antonio, Texas, United States

Investigational Site Number 840018

San Antonio, Texas, United States

Investigational Site Number 840434

San Antonio, Texas, United States

Investigational Site Number 840390

San Antonio, Texas, United States

Investigational Site Number 840207

Schertz, Texas, United States

Investigational Site Number 840615

Sealy, Texas, United States

Investigational Site Number 840097

Sugar Land, Texas, United States

Investigational Site Number 840460

Sugar Land, Texas, United States

Investigational Site Number 840514

Sugar Land, Texas, United States

Investigational Site Number 840530

Sugar Land, Texas, United States

Investigational Site Number 840008

Waco, Texas, United States

Investigational Site Number 840593

Waco, Texas, United States

Investigational Site Number 840809

Waxahachie, Texas, United States

Investigational Site Number 840651

Webster, Texas, United States

Investigational Site Number 840392

Clinton, Utah, United States

Investigational Site Number 840228

Salt Lake City, Utah, United States

Investigational Site Number 840189

St. George, Utah, United States

Investigational Site Number 840765

West Jordan, Utah, United States

Investigational Site Number 840806

West Jordan, Utah, United States

Investigational Site Number 840580

Chatham, Virginia, United States

Investigational Site Number 840590

Chesapeake, Virginia, United States

Investigational Site Number 840788

Danville, Virginia, United States

Investigational Site Number 840706

Danville, Virginia, United States

Investigational Site Number 840736

Danville, Virginia, United States

Investigational Site Number 840575

Fredericksburg, Virginia, United States

Investigational Site Number 840662

Hampton, Virginia, United States

Investigational Site Number 840795

Lynchburg, Virginia, United States

Investigational Site Number 840605

Martinsville, Virginia, United States

Investigational Site Number 840620

Newport News, Virginia, United States

Investigational Site Number 840088

Norfolk, Virginia, United States

Investigational Site Number 840247

North Chesterfield, Virginia, United States

Investigational Site Number 840730

Pennington Gap, Virginia, United States

Investigational Site Number 840179

Richmond, Virginia, United States

Investigational Site Number 840076

Salem, Virginia, United States

Investigational Site Number 840354

Virginia Beach, Virginia, United States

Investigational Site Number 840704

Winchester, Virginia, United States

Investigational Site Number 840709

Everett, Washington, United States

Investigational Site Number 840238

Federal Way, Washington, United States

Investigational Site Number 840588

Vancouver, Washington, United States

Investigational Site Number 840084

Walla Walla, Washington, United States

Investigational Site Number 840658

Charleston, West Virginia, United States

Investigational Site Number 840595

Lewisburg, West Virginia, United States

Investigational Site Number 124002

Barrie, , Canada

Investigational Site Number 124005

Brampton, , Canada

Investigational Site Number 124001

Brampton, , Canada

Investigational Site Number 124030

Burlington, , Canada

Investigational Site Number 124017

Calgary, , Canada

Investigational Site Number 124013

Concord, , Canada

Investigational Site Number 124018

Etobicoke, , Canada

Investigational Site Number 124014

Etobicoke, , Canada

Investigational Site Number 124026

Guelph, , Canada

Investigational Site Number 124008

Hamilton, , Canada

Investigational Site Number 124027

Hamilton, , Canada

Investigational Site Number 124010

London, , Canada

Investigational Site Number 124015

Markham, , Canada

Investigational Site Number 124020

Montreal, , Canada

Investigational Site Number 124016

Newmarket, , Canada

Investigational Site Number 124024

Oakville, , Canada

Investigational Site Number 124029

Saint-Laurent, , Canada

Investigational Site Number 124007

Surrey, , Canada

Investigational Site Number 124003

Toronto, , Canada

Investigational Site Number 124025

Vancouver, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 33509703 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27690710 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1168-0354

Identifier Type: OTHER

Identifier Source: secondary_id

LPS14347

Identifier Type: -

Identifier Source: org_study_id