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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

NCT ID: NCT01676220

Last Updated: 2015-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

\- occurrence of nocturnal hypoglycemia

Related Clinical Trials

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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

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Type 2 Diabetes Mellitus
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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

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Type 2 Diabetes Mellitus
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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

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Type 1 Diabetes Mellitus
COMPLETED PHASE3

Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

NCT02855684

Type 2 Diabetes Mellitus
COMPLETED PHASE3

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

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COMPLETED PHASE2

Detailed Description

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The maximum study duration was up to approximately 54 weeks per participant, consisting of:

* Up to 2 week screening period; it can be exceptionally extended of up to one additional week
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 2-day post-treatment safety follow-up period

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HOE901-U300

Group Type EXPERIMENTAL

HOE901-U300 (new formulation of insulin glargine)

Intervention Type DRUG

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

Lantus

Group Type ACTIVE_COMPARATOR

Lantus (insulin glargine)

Intervention Type DRUG

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Interventions

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HOE901-U300 (new formulation of insulin glargine)

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

Intervention Type DRUG

Lantus (insulin glargine)

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Intervention Type DRUG

Other Intervention Names

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Lantus

Eligibility Criteria

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Inclusion Criteria

* Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
* Signed written informed consent.

Exclusion Criteria

* HbA1c less than (\<) 7.0% (\< 53 millimole per mole \[mmol/mol\]) or greater than (\>) 11% (\> 97 mmol/mol)
* History of type 2 diabetes mellitus for less than 1 year before screening
* Less than 6 months before screening with non-insulin antihyperglycemic treatment
* Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening
* Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
* Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
* Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840324

Montgomery, Alabama, United States

Site Status

Investigational Site Number 840273

Chandler, Arizona, United States

Site Status

Investigational Site Number 840217

Mesa, Arizona, United States

Site Status

Investigational Site Number 840220

Peoria, Arizona, United States

Site Status

Investigational Site Number 840211

Phoenix, Arizona, United States

Site Status

Investigational Site Number 840207

Phoenix, Arizona, United States

Site Status

Investigational Site Number 840264

Tempe, Arizona, United States

Site Status

Investigational Site Number 840234

Tempe, Arizona, United States

Site Status

Investigational Site Number 840304

Little Rock, Arkansas, United States

Site Status

Investigational Site Number 840347

Bell Gardens, California, United States

Site Status

Investigational Site Number 840244

Escondido, California, United States

Site Status

Investigational Site Number 840257

Fresno, California, United States

Site Status

Investigational Site Number 840213

Greenbrae, California, United States

Site Status

Investigational Site Number 840267

Huntington Beach, California, United States

Site Status

Investigational Site Number 840230

La Jolla, California, United States

Site Status

Investigational Site Number 840235

La Mesa, California, United States

Site Status

Investigational Site Number 840274

La Mesa, California, United States

Site Status

Investigational Site Number 840222

Long Beach, California, United States

Site Status

Investigational Site Number 840243

Palm Springs, California, United States

Site Status

Investigational Site Number 840250

Spring Valley, California, United States

Site Status

Investigational Site Number 840209

Temecula, California, United States

Site Status

Investigational Site Number 840297

Torrance, California, United States

Site Status

Investigational Site Number 840272

Tustin, California, United States

Site Status

Investigational Site Number 840223

Walnut Creek, California, United States

Site Status

Investigational Site Number 840249

Colorado Springs, Colorado, United States

Site Status

Investigational Site Number 840331

Denver, Colorado, United States

Site Status

Investigational Site Number 840299

Boca Raton, Florida, United States

Site Status

Investigational Site Number 840285

Boynton Beach, Florida, United States

Site Status

Investigational Site Number 840221

Bradenton, Florida, United States

Site Status

Investigational Site Number 840233

Clearwater, Florida, United States

Site Status

Investigational Site Number 840212

Coral Gables, Florida, United States

Site Status

Investigational Site Number 840266

Coral Gables, Florida, United States

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Investigational Site Number 840204

Hialeah, Florida, United States

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Investigational Site Number 840248

Hollywood, Florida, United States

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Investigational Site Number 840226

Jacksonville, Florida, United States

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Investigational Site Number 840318

Jacksonville, Florida, United States

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Investigational Site Number 840224

Jacksonville, Florida, United States

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Investigational Site Number 840228

Miami, Florida, United States

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Investigational Site Number 840238

Miami, Florida, United States

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Investigational Site Number 840302

Miami, Florida, United States

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Investigational Site Number 840337

Miami Beach, Florida, United States

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Investigational Site Number 840227

New Port Richey, Florida, United States

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Investigational Site Number 840303

North Miami Beach, Florida, United States

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Investigational Site Number 840225

Ocala, Florida, United States

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Investigational Site Number 840291

Orlando, Florida, United States

Site Status

Investigational Site Number 840316

Orlando, Florida, United States

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Investigational Site Number 840216

Oviedo, Florida, United States

Site Status

Investigational Site Number 840332

Palm Harbor, Florida, United States

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Investigational Site Number 840288

Pembroke Pines, Florida, United States

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Investigational Site Number 840325

Port Charlotte, Florida, United States

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Investigational Site Number 840309

St. Petersburg, Florida, United States

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Investigational Site Number 840251

Tampa, Florida, United States

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Investigational Site Number 840339

West Palm Beach, Florida, United States

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Investigational Site Number 840245

Atlanta, Georgia, United States

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Investigational Site Number 840323

Stockbridge, Georgia, United States

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Investigational Site Number 840236

Honolulu, Hawaii, United States

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Investigational Site Number 840283

Idaho Falls, Idaho, United States

Site Status

Investigational Site Number 840278

Chicago, Illinois, United States

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Investigational Site Number 840320

Chicago, Illinois, United States

Site Status

Investigational Site Number 840276

Springfield, Illinois, United States

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Investigational Site Number 840314

Avon, Indiana, United States

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Investigational Site Number 840317

Avon, Indiana, United States

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Investigational Site Number 840214

Des Moines, Iowa, United States

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Investigational Site Number 840232

Overland Park, Kansas, United States

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Investigational Site Number 840287

Topeka, Kansas, United States

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Investigational Site Number 840344

Lexington, Kentucky, United States

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Investigational Site Number 840231

Murray, Kentucky, United States

Site Status

Investigational Site Number 840348

Metairie, Louisiana, United States

Site Status

Investigational Site Number 840290

New Orleans, Louisiana, United States

Site Status

Investigational Site Number 840208

Baltimore, Maryland, United States

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Investigational Site Number 840301

Rockville, Maryland, United States

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Investigational Site Number 840289

Fall River, Massachusetts, United States

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Investigational Site Number 840253

Haverhill, Massachusetts, United States

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Investigational Site Number 840270

Madison Heights, Michigan, United States

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Investigational Site Number 840300

Omaha, Nebraska, United States

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Investigational Site Number 840210

Omaha, Nebraska, United States

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Investigational Site Number 840263

Omaha, Nebraska, United States

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Investigational Site Number 840349

Las Vegas, Nevada, United States

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Investigational Site Number 840201

Las Vegas, Nevada, United States

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Investigational Site Number 840256

Las Vegas, Nevada, United States

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Investigational Site Number 840306

Hamilton, New Jersey, United States

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Investigational Site Number 840203

Sea Girt, New Jersey, United States

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Investigational Site Number 840295

Sicklerville, New Jersey, United States

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Investigational Site Number 840269

Albuquerque, New Mexico, United States

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Investigational Site Number 840310

New Hyde Park, New York, United States

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Investigational Site Number 840247

Asheville, North Carolina, United States

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Investigational Site Number 840296

Greensboro, North Carolina, United States

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Investigational Site Number 840275

Morganton, North Carolina, United States

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Investigational Site Number 840330

Cleveland, Ohio, United States

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Investigational Site Number 840307

Columbus, Ohio, United States

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Investigational Site Number 840229

Norman, Oklahoma, United States

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Investigational Site Number 840219

Bend, Oregon, United States

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Investigational Site Number 840240

Philadelphia, Pennsylvania, United States

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Investigational Site Number 840308

Tipton, Pennsylvania, United States

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Investigational Site Number 840252

Greer, South Carolina, United States

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Investigational Site Number 840237

Spartanburg, South Carolina, United States

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Investigational Site Number 840294

Dakota Dunes, South Dakota, United States

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Investigational Site Number 840260

Bristol, Tennessee, United States

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Investigational Site Number 840262

Chattanooga, Tennessee, United States

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Investigational Site Number 840342

Corpus Christi, Texas, United States

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Investigational Site Number 840268

Dallas, Texas, United States

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Investigational Site Number 840292

Dallas, Texas, United States

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Investigational Site Number 840315

Dallas, Texas, United States

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Investigational Site Number 840242

Dallas, Texas, United States

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Investigational Site Number 840326

Edinburg, Texas, United States

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Investigational Site Number 840338

Houston, Texas, United States

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Investigational Site Number 840218

Houston, Texas, United States

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Investigational Site Number 840328

Houston, Texas, United States

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Investigational Site Number 840259

Houston, Texas, United States

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Investigational Site Number 840327

Pearland, Texas, United States

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Investigational Site Number 840282

San Antonio, Texas, United States

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Investigational Site Number 840202

Murray, Utah, United States

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Investigational Site Number 840343

Salt Lake City, Utah, United States

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Investigational Site Number 840239

Burke, Virginia, United States

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Investigational Site Number 840206

Manassas, Virginia, United States

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Investigational Site Number 840246

Renton, Washington, United States

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Investigational Site Number 840311

Milwaukee, Wisconsin, United States

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Investigational Site Number 100205

Blagoevgrad, , Bulgaria

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Investigational Site Number 100203

Byala, , Bulgaria

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Investigational Site Number 100201

Plovdiv, , Bulgaria

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Investigational Site Number 100204

Plovdiv, , Bulgaria

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Investigational Site Number 100206

Sofia, , Bulgaria

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Investigational Site Number 124204

Brampton, , Canada

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Investigational Site Number 124211

Etobicoke, , Canada

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Investigational Site Number 124208

Laval, , Canada

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Investigational Site Number 124214

London, , Canada

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Investigational Site Number 124210

Montreal, , Canada

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Investigational Site Number 124218

Montreal, , Canada

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Investigational Site Number 124206

Pointe-Claire, , Canada

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Investigational Site Number 124216

Saint-Laurent, , Canada

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Investigational Site Number 124219

Sherbrooke, , Canada

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Investigational Site Number 124201

Thornhill, , Canada

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Investigational Site Number 124209

Thornhill, , Canada

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Investigational Site Number 124212

Toronto, , Canada

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Investigational Site Number 203201

Brno, , Czechia

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Investigational Site Number 203205

Brno, , Czechia

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Investigational Site Number 203204

Havířov, , Czechia

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Investigational Site Number 203203

Prague, , Czechia

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Investigational Site Number 203202

Prague, , Czechia

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Investigational Site Number 208205

Aalborg, , Denmark

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Investigational Site Number 208203

Esbjerg, , Denmark

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Investigational Site Number 208209

Hellerup, , Denmark

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Investigational Site Number 208202

Herlev, , Denmark

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Investigational Site Number 208206

Hvidovre, , Denmark

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Investigational Site Number 208210

Kolding, , Denmark

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Investigational Site Number 208207

København NV, , Denmark

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Investigational Site Number 208201

Odense C, , Denmark

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Investigational Site Number 208204

Viborg, , Denmark

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Investigational Site Number 233204

Tallinn, , Estonia

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Investigational Site Number 233203

Tartu, , Estonia

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Investigational Site Number 233205

Tartu, , Estonia

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Investigational Site Number 246208

Helsinki, , Finland

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Investigational Site Number 246202

Kokkola, , Finland

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Investigational Site Number 246207

Oulu, , Finland

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Investigational Site Number 246206

Tampere, , Finland

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Investigational Site Number 246205

Turku, , Finland

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Investigational Site Number 348205

Balassagyarmat, , Hungary

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Investigational Site Number 348201

Budapest, , Hungary

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Investigational Site Number 348207

Budapest, , Hungary

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Investigational Site Number 348212

Budapest, , Hungary

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Investigational Site Number 348210

Budapest, , Hungary

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Investigational Site Number 348202

Úrhida, , Hungary

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Investigational Site Number 392214

Fujimi, , Japan

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Investigational Site Number 392215

Fujimi, , Japan

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Investigational Site Number 392206

Ise-Shi, , Japan

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Investigational Site Number 392217

Kitaazumi-Gun, , Japan

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Investigational Site Number 392208

Matsumoto, , Japan

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Investigational Site Number 392210

Matsumoto-Shi, , Japan

Site Status

Investigational Site Number 392205

Midori, , Japan

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Investigational Site Number 392203

Mito, , Japan

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Investigational Site Number 392216

Sakai, , Japan

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Investigational Site Number 392213

Shimotsuke, , Japan

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Investigational Site Number 392218

Shunan-Shi, , Japan

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Investigational Site Number 392204

Yamagata, , Japan

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Investigational Site Number 428206

Riga, , Latvia

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Investigational Site Number 428203

Riga, , Latvia

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Investigational Site Number 428205

Riga, , Latvia

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Investigational Site Number 428202

Sigulda, , Latvia

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Investigational Site Number 428201

Ventspils, , Latvia

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Investigational Site Number 440203

Kaunas, , Lithuania

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Investigational Site Number 440204

Kaunas, , Lithuania

Site Status

Investigational Site Number 440201

Klaipėda, , Lithuania

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Investigational Site Number 440202

Klaipėda, , Lithuania

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Investigational Site Number 440205

Vilnius, , Lithuania

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Investigational Site Number 528204

Almere Stad, , Netherlands

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Investigational Site Number 528209

Beek, , Netherlands

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Investigational Site Number 528205

Breda, , Netherlands

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Investigational Site Number 528207

Leiderdorp, , Netherlands

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Investigational Site Number 528203

Rotterdam, , Netherlands

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Investigational Site Number 528202

Velp, , Netherlands

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Investigational Site Number 840709

Cagua, , Puerto Rico

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Investigational Site Number 840706

Carolina, , Puerto Rico

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Investigational Site Number 840704

San Juan, , Puerto Rico

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Investigational Site Number 840710

San Juan, , Puerto Rico

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Investigational Site Number 840703

San Juan, , Puerto Rico

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Investigational Site Number 840708

San Juan, , Puerto Rico

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Investigational Site Number 642208

Bacau, , Romania

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Investigational Site Number 642212

Bucharest, , Romania

Site Status

Investigational Site Number 642201

Bucharest, , Romania

Site Status

Investigational Site Number 642202

Cluj-Napoca, , Romania

Site Status

Investigational Site Number 642213

Oradea, , Romania

Site Status

Investigational Site Number 642207

Reşiţa, , Romania

Site Status

Investigational Site Number 642205

Sibiu, , Romania

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Investigational Site Number 642203

Târgu Mureş, , Romania

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Investigational Site Number 642204

Târgu Mureş, , Romania

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Investigational Site Number 642206

Timișoara, , Romania

Site Status

Investigational Site Number 642209

Timișoara, , Romania

Site Status

Investigational Site Number 703205

Banská Bystrica, , Slovakia

Site Status

Investigational Site Number 703202

Bardejov, , Slovakia

Site Status

Investigational Site Number 703203

Bratislava, , Slovakia

Site Status

Investigational Site Number 703201

Levice, , Slovakia

Site Status

Investigational Site Number 703206

Levice, , Slovakia

Site Status

Investigational Site Number 703207

Lučenec, , Slovakia

Site Status

Investigational Site Number 752205

Kristianstad, , Sweden

Site Status

Investigational Site Number 752206

Malmo, , Sweden

Site Status

Investigational Site Number 752201

Stockholm, , Sweden

Site Status

Investigational Site Number 752204

Vällingby, , Sweden

Site Status

Countries

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United States Bulgaria Canada Czechia Denmark Estonia Finland Hungary Japan Latvia Lithuania Netherlands Puerto Rico Romania Slovakia Sweden

References

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Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.

Reference Type RESULT
PMID: 25641260 (View on PubMed)

Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

Reference Type DERIVED
PMID: 30366067 (View on PubMed)

Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.

Reference Type DERIVED
PMID: 30160030 (View on PubMed)

Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.

Reference Type DERIVED
PMID: 29370218 (View on PubMed)

Other Identifiers

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2012-000146-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1124-5261

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12347

Identifier Type: -

Identifier Source: org_study_id

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Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)
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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
NCT02058160 COMPLETED PHASE3
Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus
NCT02201199 COMPLETED PHASE1
A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
NCT00399724 COMPLETED PHASE4
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
NCT02735044 COMPLETED PHASE3
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
NCT00467376 COMPLETED PHASE3
Insulin Glargine in Type 1 Diabetes Mellitus
NCT00272090 COMPLETED PHASE3
Glycemic Optimization Treatment Study
NCT00552370 COMPLETED PHASE4
Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus
NCT00565162 COMPLETED PHASE4
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
NCT00046462 COMPLETED PHASE3
Insulin Glargine Versus Twice-Daily NPH
NCT00687453 TERMINATED PHASE4
Insulin Glargine at Bedtime or in AM Versus NPH
NCT00686712 COMPLETED PHASE4
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
NCT03798054 COMPLETED PHASE3
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
NCT03359837 COMPLETED PHASE4
A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
NCT04575181 COMPLETED PHASE1
Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
NCT00965549 COMPLETED PHASE4
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
NCT00653302 COMPLETED PHASE4