AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3EDITION IIINCT01676220

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

A Phase 3 study testing HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) in people with Type 2 Diabetes Mellitus, run by Sanofi at 217 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
878 participants
Where
217 sitesin 16 countries
Study dates
Aug 2012to Mar 2014
Phase
Phase 3
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

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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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.

Trial locations and contacts

217 sites in 16 countries.

217 sites in 16 countries

United States117 sites

  • Investigational Site Number 840269

    Albuquerque, New Mexico, 87106

  • Investigational Site Number 840247

    Asheville, North Carolina, 28803

  • Investigational Site Number 840245

    Atlanta, Georgia, 30308

  • Investigational Site Number 840314

    Avon, Indiana, 46123

  • Investigational Site Number 840317

    Avon, Indiana, 46123

  • Investigational Site Number 840208

    Baltimore, Maryland, 21237

  • Investigational Site Number 840347

    Bell Gardens, California, 90201

  • Investigational Site Number 840219

    Bend, Oregon, 97701

  • Investigational Site Number 840299

    Boca Raton, Florida, 33432

  • Investigational Site Number 840285

    Boynton Beach, Florida, 33472

  • Investigational Site Number 840221

    Bradenton, Florida, 34208

  • Investigational Site Number 840260

    Bristol, Tennessee, 37620

  • Investigational Site Number 840239

    Burke, Virginia, 22015

  • Investigational Site Number 840273

    Chandler, Arizona, 85224

  • Investigational Site Number 840262

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840278

    Chicago, Illinois, 60607

  • Investigational Site Number 840320

    Chicago, Illinois, 60612

  • Investigational Site Number 840233

    Clearwater, Florida, 33765

  • Investigational Site Number 840330

    Cleveland, Ohio, 44122

  • Investigational Site Number 840249

    Colorado Springs, Colorado, 80907

  • Investigational Site Number 840307

    Columbus, Ohio, 43213

  • Investigational Site Number 840212

    Coral Gables, Florida, 33134

  • Investigational Site Number 840266

    Coral Gables, Florida, 33134

  • Investigational Site Number 840342

    Corpus Christi, Texas, 78404

  • Investigational Site Number 840294

    Dakota Dunes, South Dakota, 57049

  • Investigational Site Number 840268

    Dallas, Texas, 75230

  • Investigational Site Number 840292

    Dallas, Texas, 75230

  • Investigational Site Number 840315

    Dallas, Texas, 75231

  • Investigational Site Number 840242

    Dallas, Texas, 75246

  • Investigational Site Number 840331

    Denver, Colorado, 80212

  • Investigational Site Number 840214

    Des Moines, Iowa, 50314

  • Investigational Site Number 840326

    Edinburg, Texas, 78539

  • Investigational Site Number 840244

    Escondido, California, 92025

  • Investigational Site Number 840289

    Fall River, Massachusetts, 02720

  • Investigational Site Number 840257

    Fresno, California, 93720

  • Investigational Site Number 840213

    Greenbrae, California, 94904

  • Investigational Site Number 840296

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840252

    Greer, South Carolina, 29651

  • Investigational Site Number 840306

    Hamilton, New Jersey, 08619

  • Investigational Site Number 840253

    Haverhill, Massachusetts, 1830

  • Investigational Site Number 840204

    Hialeah, Florida, 33012

  • Investigational Site Number 840248

    Hollywood, Florida, 33021

  • Investigational Site Number 840236

    Honolulu, Hawaii, 96814

  • Investigational Site Number 840338

    Houston, Texas, 77002

  • Investigational Site Number 840218

    Houston, Texas, 77004

  • Investigational Site Number 840328

    Houston, Texas, 77074

  • Investigational Site Number 840259

    Houston, Texas, 77095

  • Investigational Site Number 840267

    Huntington Beach, California, 92648

  • Investigational Site Number 840283

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840226

    Jacksonville, Florida, 32205

  • Investigational Site Number 840318

    Jacksonville, Florida, 32216

  • Investigational Site Number 840224

    Jacksonville, Florida, 32258

  • Investigational Site Number 840230

    La Jolla, California, 92037

  • Investigational Site Number 840235

    La Mesa, California, 91942

  • Investigational Site Number 840274

    La Mesa, California, 91942

  • Investigational Site Number 840349

    Las Vegas, Nevada, 89117

  • Investigational Site Number 840201

    Las Vegas, Nevada, 89119

  • Investigational Site Number 840256

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840344

    Lexington, Kentucky, 40503

  • Investigational Site Number 840304

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840222

    Long Beach, California, 90806

  • Investigational Site Number 840270

    Madison Heights, Michigan, 48071

  • Investigational Site Number 840206

    Manassas, Virginia, 20110

  • Investigational Site Number 840217

    Mesa, Arizona, 85206

  • Investigational Site Number 840348

    Metairie, Louisiana, 70006

  • Investigational Site Number 840228

    Miami, Florida, 33144

  • Investigational Site Number 840238

    Miami, Florida, 33144

  • Investigational Site Number 840302

    Miami, Florida, 33176

  • Investigational Site Number 840337

    Miami Beach, Florida, 33141

  • Investigational Site Number 840311

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840324

    Montgomery, Alabama, 36109

  • Investigational Site Number 840275

    Morganton, North Carolina, 28655

  • Investigational Site Number 840231

    Murray, Kentucky, 42003

  • Investigational Site Number 840202

    Murray, Utah, 84123

  • Investigational Site Number 840310

    New Hyde Park, New York, 11042

  • Investigational Site Number 840290

    New Orleans, Louisiana, 70119

  • Investigational Site Number 840227

    New Port Richey, Florida, 34652

  • Investigational Site Number 840229

    Norman, Oklahoma, 73069

  • Investigational Site Number 840303

    North Miami Beach, Florida, 33162

  • Investigational Site Number 840225

    Ocala, Florida, 34471

  • Investigational Site Number 840300

    Omaha, Nebraska, 68105

  • Investigational Site Number 840210

    Omaha, Nebraska, 68131

  • Investigational Site Number 840263

    Omaha, Nebraska, 68131

  • Investigational Site Number 840291

    Orlando, Florida, 32804

  • Investigational Site Number 840316

    Orlando, Florida, 32806

  • Investigational Site Number 840232

    Overland Park, Kansas, 66210

  • Investigational Site Number 840216

    Oviedo, Florida, 32765

  • Investigational Site Number 840332

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840243

    Palm Springs, California, 92262

  • Investigational Site Number 840327

    Pearland, Texas, 77584

  • Investigational Site Number 840288

    Pembroke Pines, Florida, 33028

  • Investigational Site Number 840220

    Peoria, Arizona, 85050

  • Investigational Site Number 840240

    Philadelphia, Pennsylvania, 19139

  • Investigational Site Number 840211

    Phoenix, Arizona, 85028

  • Investigational Site Number 840207

    Phoenix, Arizona, 85050

  • Investigational Site Number 840325

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840246

    Renton, Washington, 98055

  • Investigational Site Number 840301

    Rockville, Maryland, 20852

  • Investigational Site Number 840343

    Salt Lake City, Utah, 84107

  • Investigational Site Number 840282

    San Antonio, Texas, 78229

  • Investigational Site Number 840203

    Sea Girt, New Jersey, 08750

  • Investigational Site Number 840295

    Sicklerville, New Jersey, 08081

  • Investigational Site Number 840237

    Spartanburg, South Carolina, 29303

  • Investigational Site Number 840250

    Spring Valley, California, 91978

  • Investigational Site Number 840276

    Springfield, Illinois, 62704

  • Investigational Site Number 840309

    St. Petersburg, Florida, 33716

  • Investigational Site Number 840323

    Stockbridge, Georgia, 30281

  • Investigational Site Number 840251

    Tampa, Florida, 33603

  • Investigational Site Number 840209

    Temecula, California, 92591

  • Investigational Site Number 840264

    Tempe, Arizona, 85282

  • Investigational Site Number 840234

    Tempe, Arizona

  • Investigational Site Number 840308

    Tipton, Pennsylvania, 16684

  • Investigational Site Number 840287

    Topeka, Kansas, 66606

  • Investigational Site Number 840297

    Torrance, California, 90502

  • Investigational Site Number 840272

    Tustin, California, 92780

  • Investigational Site Number 840223

    Walnut Creek, California, 94598

  • Investigational Site Number 840339

    West Palm Beach, Florida, 33401

Other trials in United States

Canada12 sites

  • Investigational Site Number 124204

    Brampton, L6R 3J5

  • Investigational Site Number 124211

    Etobicoke, M9R 4E1

  • Investigational Site Number 124208

    Laval, H7T 2P5

  • Investigational Site Number 124214

    London, N6A 5G6

  • Investigational Site Number 124210

    Montreal, H1Y 3L1

  • Investigational Site Number 124218

    Montreal, H4N 3C5

  • Investigational Site Number 124206

    Pointe-Claire, H9R 4S3

  • Investigational Site Number 124216

    Saint-Laurent, H4T 1Z9

  • Investigational Site Number 124219

    Sherbrooke, J1H 1Z1

  • Investigational Site Number 124201

    Thornhill, L4J 8L7

  • Investigational Site Number 124209

    Thornhill, L4J 8L7

  • Investigational Site Number 124212

    Toronto, M9W 4L9

Other trials in Canada

Japan12 sites

  • Investigational Site Number 392214

    Fujimi

  • Investigational Site Number 392215

    Fujimi

  • Investigational Site Number 392206

    Ise-Shi

  • Investigational Site Number 392217

    Kitaazumi-Gun

  • Investigational Site Number 392208

    Matsumoto

  • Investigational Site Number 392210

    Matsumoto-Shi

  • Investigational Site Number 392205

    Midori

  • Investigational Site Number 392203

    Mito

  • Investigational Site Number 392216

    Sakai

  • Investigational Site Number 392213

    Shimotsuke

  • Investigational Site Number 392218

    Shunan-Shi

  • Investigational Site Number 392204

    Yamagata

Other trials in Japan

Romania11 sites

  • Investigational Site Number 642208

    Bacau, 600164

  • Investigational Site Number 642212

    Bucharest, 020359

  • Investigational Site Number 642201

    Bucharest, 20475

  • Investigational Site Number 642202

    Cluj-Napoca, 400006

  • Investigational Site Number 642213

    Oradea, 410169

  • Investigational Site Number 642207

    Reşiţa, 320076

  • Investigational Site Number 642205

    Sibiu, 550371

  • Investigational Site Number 642203

    Târgu Mureş, 540142

  • Investigational Site Number 642204

    Târgu Mureş, 540142

  • Investigational Site Number 642206

    Timișoara, 300133

  • Investigational Site Number 642209

    Timișoara, 300456

Other trials in Romania

Denmark9 sites

  • Investigational Site Number 208205

    Aalborg, 9100

  • Investigational Site Number 208203

    Esbjerg, 6700

  • Investigational Site Number 208209

    Hellerup, 2900

  • Investigational Site Number 208202

    Herlev, 2730

  • Investigational Site Number 208206

    Hvidovre, 2650

  • Investigational Site Number 208207

    København NV, 2400

  • Investigational Site Number 208210

    Kolding, 6000

  • Investigational Site Number 208201

    Odense C, 5000

  • Investigational Site Number 208204

    Viborg, 8800

Other trials in Denmark

Hungary6 sites

  • Investigational Site Number 348205

    Balassagyarmat, 2660

  • Investigational Site Number 348201

    Budapest, 1036

  • Investigational Site Number 348207

    Budapest, 1036

  • Investigational Site Number 348212

    Budapest, 1083

  • Investigational Site Number 348210

    Budapest, 1134

  • Investigational Site Number 348202

    Úrhida, 8142

Other trials in Hungary

Netherlands6 sites

  • Investigational Site Number 528204

    Almere Stad, 1311 RL

  • Investigational Site Number 528209

    Beek, 6191 JW

  • Investigational Site Number 528205

    Breda, 4811 SW

  • Investigational Site Number 528207

    Leiderdorp, 2352 RA

  • Investigational Site Number 528203

    Rotterdam, 3021 HC

  • Investigational Site Number 528202

    Velp, 6883 ES

Other trials in Netherlands

Puerto Rico6 sites

  • Investigational Site Number 840709

    Cagua, 725

  • Investigational Site Number 840706

    Carolina, 987

  • Investigational Site Number 840704

    San Juan, 00917

  • Investigational Site Number 840710

    San Juan, 00917

  • Investigational Site Number 840703

    San Juan, 917

  • Investigational Site Number 840708

    San Juan, 926

Other trials in Puerto Rico

Slovakia6 sites

  • Investigational Site Number 703205

    Banská Bystrica, 97517

  • Investigational Site Number 703202

    Bardejov, 085 01

  • Investigational Site Number 703203

    Bratislava, 85101

  • Investigational Site Number 703201

    Levice, 93405

  • Investigational Site Number 703206

    Levice, 95401

  • Investigational Site Number 703207

    Lučenec, 98401

Other trials in Slovakia

Bulgaria5 sites

  • Investigational Site Number 100205

    Blagoevgrad, 2700

  • Investigational Site Number 100203

    Byala, 7100

  • Investigational Site Number 100201

    Plovdiv, 4002

  • Investigational Site Number 100204

    Plovdiv, 4002

  • Investigational Site Number 100206

    Sofia, 1431

Other trials in Bulgaria

Czechia5 sites

  • Investigational Site Number 203201

    Brno, 62500

  • Investigational Site Number 203205

    Brno, 65691

  • Investigational Site Number 203204

    Havířov, 73601

  • Investigational Site Number 203203

    Prague, 10034

  • Investigational Site Number 203202

    Prague, 18100

Other trials in Czechia

Finland5 sites

  • Investigational Site Number 246208

    Helsinki, 260

  • Investigational Site Number 246202

    Kokkola, 67100

  • Investigational Site Number 246207

    Oulu, 90100

  • Investigational Site Number 246206

    Tampere, 33100

  • Investigational Site Number 246205

    Turku, 20100

Other trials in Finland

Latvia5 sites

  • Investigational Site Number 428206

    Riga, 1024

  • Investigational Site Number 428203

    Riga, LV-1002

  • Investigational Site Number 428205

    Riga, LV-1050

  • Investigational Site Number 428202

    Sigulda, LV-2150

  • Investigational Site Number 428201

    Ventspils, LV-3601

Other trials in Latvia

Lithuania5 sites

  • Investigational Site Number 440203

    Kaunas, 48259

  • Investigational Site Number 440204

    Kaunas, LT-49456

  • Investigational Site Number 440201

    Klaipėda, LT-92253

  • Investigational Site Number 440202

    Klaipėda, LT-92304

  • Investigational Site Number 440205

    Vilnius, LT-08661

Other trials in Lithuania

Sweden4 sites

  • Investigational Site Number 752205

    Kristianstad, 29185

  • Investigational Site Number 752206

    Malmö, 211 52

  • Investigational Site Number 752201

    Stockholm, 11526

  • Investigational Site Number 752204

    Vällingby, 16268

Other trials in Sweden

Estonia3 sites

  • Investigational Site Number 233204

    Tallinn, 13419

  • Investigational Site Number 233203

    Tartu, 50406

  • Investigational Site Number 233205

    Tartu, 50410

Other trials in Estonia

About this study

Official title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period

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
Read the detailed description

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
Being tested
HOE901-U300 (new formulation of insulin glargine), Lantus (insulin glargine)
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.

  • HOE901-U300 (new formulation of insulin glargine)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 (insulin glargine)Drug

    Also called Lantus

    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).

Study groups in NCT01676220
Study groupRoleWhat they receive
HOE901-U300ExperimentalNot described
Receives: Drug: HOE901-U300 (new formulation of insulin glargine)
LantusActive comparatorNot described
Receives: Drug: Lantus (insulin glargine)

What is being measured

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

  1. Change in HbA1c From Baseline to Month 6 Endpoint

    Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

Secondary outcomes (12)

  1. Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6

    Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.

    Measured: Week 9 Up to Month 6

  2. Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint

    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

  3. Variability of Preinjection SMPG at Month 6 Endpoint

    Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Month 6

  4. Percentage of Participants With HbA1c <7% at Month 6

    Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

    Measured: Month 6

  5. Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint

    Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

  6. Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6

    Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

    Measured: Month 6

  7. Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6

    Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

    Measured: Baseline, Month 6

  8. Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint

    Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

  9. Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint

    Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

  10. Change in Daily Basal Insulin Dose From Baseline to Month 6

    Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.

    Measured: Baseline, Month 6

  11. Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint

    DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.

    Measured: Baseline, Month 6

  12. Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12

    Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).

    Measured: Up to 12 months

Timeline

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

  1. First posted30 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionSep 2013
  4. Study completionMar 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01676220
Sponsor's protocol ID
EFC12347
Other IDs
2012-000146-35, U1111-1124-5261
Acronym
EDITION III
Status last verified
May 2015
First submitted
28 Aug 2012
Last updated
24 Jun 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 25641260

  • 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.

    PubMed 30366067

  • 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.

    PubMed 30160030

  • 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.

    PubMed 29370218

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) in people with Type 2 Diabetes Mellitus, run by Sanofi at 217 sites in 16 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 9 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, Canada, Japan, Romania, Denmark and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Apr 2015). 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?

Change in HbA1c From Baseline to Month 6 Endpoint (time frame: Baseline, 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 NCT01676220, which also lists 4 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 24 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in