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Type 2 Diabetes MellitusPhase 3EDITION INCT01499082

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

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 193 sites in 13 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 insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus Secondary Objectives: To compare the efficacy of insulin glargine new formulation 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
807 participants
Where
193 sitesin 13 countries
Study dates
Dec 2011to Sep 2013
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

  • Participants with type 2 diabetes mellitus
  • Substudy inclusion criteria:
  • Completion of the 6-month study period in main study (Visit 10)
  • Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Who cannot join

  • Age less than (<) 18 years
  • HbA1c <7.0% or greater than (>) 10% at screening
  • Diabetes other than type 2 diabetes mellitus
  • Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
  • Any contraindication to use of insulin glargine as defined in the national product label
  • Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
Show all 13Show fewer
  • Use of an insulin pump in the last 6 months before screening visit
  • Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit
  • History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study period
  • Substudy exclusion criteria:
  • Participant not willing to use the adaptable injection intervals on at least two days per week
  • 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

193 sites in 13 countries.

193 sites in 13 countries

United States95 sites

  • Investigational Site Number 840076

    Anaheim, California, 92801

  • Investigational Site Number 840065

    Ann Arbor, Michigan, 48106

  • Investigational Site Number 840146

    Asheville, North Carolina, 28801

  • Investigational Site Number 840021

    Austin, Texas, 78731

  • Investigational Site Number 840129

    Austin, Texas, 78731

  • Investigational Site Number 840081

    Austin, Texas, 78758

  • Investigational Site Number 840078

    Avon, Indiana, 46123

  • Investigational Site Number 840089

    Avon, Indiana, 46123

  • Investigational Site Number 840097

    Avon, Indiana, 46123

  • Investigational Site Number 840098

    Avon, Indiana, 46123

  • Investigational Site Number 840100

    Avon, Indiana, 46123

  • Investigational Site Number 840036

    Baltimore, Maryland, 21237

  • Investigational Site Number 840155

    Baltimore, Maryland, 21237

  • Investigational Site Number 840043

    Brick, New Jersey, 08274

  • Investigational Site Number 840156

    Chandler, Arizona, 85224

  • Investigational Site Number 840143

    Chaska, Minnesota, 55318

  • Investigational Site Number 840039

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840035

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840008

    Cincinnati, Ohio, 45236

  • Investigational Site Number 840114

    Colorado Springs, Colorado, 80906

  • Investigational Site Number 840136

    Colorado Springs, Colorado, 80910

  • Investigational Site Number 840106

    Columbus, Ohio, 43213

  • Investigational Site Number 840001

    Dallas, Texas, 75230

  • Investigational Site Number 840047

    Dallas, Texas, 75246

  • Investigational Site Number 840123

    Dayton, Ohio, 45439

  • Investigational Site Number 840049

    Daytona Beach, Florida, 32117

  • Investigational Site Number 840066

    Dearborn, Michigan, 48124

  • Investigational Site Number 840116

    Des Moines, Iowa, 50314

  • Investigational Site Number 840010

    Draper, Utah, 84020

  • Investigational Site Number 840068

    Eagan, Minnesota, 55122

  • Investigational Site Number 840133

    Encino, California, 91436

  • Investigational Site Number 840067

    Fargo, North Dakota, 58103

  • Investigational Site Number 840103

    Flint, Michigan, 48504

  • Investigational Site Number 840090

    Fremont, Nebraska, 68025

  • Investigational Site Number 840102

    Glendale, Arizona, 85306

  • Investigational Site Number 840062

    Greenbrae, California, 94904

  • Investigational Site Number 840079

    Greer, South Carolina, 29651

  • Investigational Site Number 840145

    Hickory, North Carolina, 28601

  • Investigational Site Number 840050

    Hollywood, Florida, 33021

  • Investigational Site Number 840016

    Hot Springs, Arkansas, 71913

  • Investigational Site Number 840082

    Houston, Texas, 77096

  • Investigational Site Number 840057

    Huntington Beach, California, 92648

  • Investigational Site Number 840120

    Hurst, Texas, 76054

  • Investigational Site Number 840052

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840086

    Jacksonville, Florida, 32204

  • Investigational Site Number 840011

    Jacksonville, Florida, 32216

  • Investigational Site Number 840009

    Jacksonville, Florida, 32258

  • Investigational Site Number 840126

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 840053

    Kalispell, Montana, 59901

  • Investigational Site Number 840159

    Knoxville, Tennessee, 37912

  • Investigational Site Number 840059

    La Jolla, California, 92037

  • Investigational Site Number 840004

    La Mesa, California, 91942

  • Investigational Site Number 840058

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840055

    Lawrenceville, Georgia, 30045

  • Investigational Site Number 840080

    Lexington, Kentucky, 40504

  • Investigational Site Number 840015

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840124

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840092

    Longmont, Colorado, 80501

  • Investigational Site Number 840119

    Maumee, Ohio, 43537

  • Investigational Site Number 840020

    McHenry, Illinois, 60050

  • Investigational Site Number 840083

    Medford, Oregon, 97504

  • Investigational Site Number 840122

    Mentor, Ohio, 44060

  • Investigational Site Number 840018

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840085

    Minneapolis, Minnesota, 55416

  • Investigational Site Number 840099

    Mission Hills, California, 91345

  • Investigational Site Number 840117

    Nampa, Idaho, 83686

  • Investigational Site Number 840023

    New Port Richey, Florida, 34652

  • Investigational Site Number 840074

    Norfolk, Virginia, 23502

  • Investigational Site Number 840112

    Norfolk, Virginia, 23507

  • Investigational Site Number 840041

    Norfolk, Virginia, 23510

  • Investigational Site Number 840012

    Ocoee, Florida, 34761

  • Investigational Site Number 840060

    Ogden, Utah, 84403

  • Investigational Site Number 840091

    Omaha, Nebraska, 68130

  • Investigational Site Number 840042

    Paducah, Kentucky, 42003

  • Investigational Site Number 840148

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840107

    Palm Springs, California, 92262

  • Investigational Site Number 840071

    Phoenix, Arizona, 85028

  • Investigational Site Number 840084

    Portland, Oregon, 97239-3098

  • Investigational Site Number 840048

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840104

    Richmond, Virginia, 23235

  • Investigational Site Number 840034

    Rockville, Maryland, 20852

  • Investigational Site Number 840005

    San Diego, California, 92161

  • Investigational Site Number 840032

    Searcy, Arkansas, 72143

  • Investigational Site Number 840022

    Southfield, Michigan, 48034

  • Investigational Site Number 840019

    Springfield, Illinois, 62704

  • Investigational Site Number 840121

    Sun City, Arizona, 85351

  • Investigational Site Number 840070

    Tempe, Arizona, 85282

  • Investigational Site Number 840152

    Toms River, New Jersey, 08721

  • Investigational Site Number 840013

    Tustin, California, 92780

  • Investigational Site Number 840007

    Uniontown, Pennsylvania, 15401

  • Investigational Site Number 840127

    Vincennes, Indiana, 47591

  • Investigational Site Number 840002

    Walnut Creek, California, 94598

  • Investigational Site Number 840003

    Wichita, Kansas, 67211

  • Investigational Site Number 840075

    Williamsburg, Virginia, 23185

  • Investigational Site Number 840045

    Wilmington, North Carolina, 28401

Other trials in United States

Canada22 sites

  • Investigational Site Number 124024

    Beamsville, L0R 1B0

  • Investigational Site Number 124025

    Burlington, L7M 4Y1

  • Investigational Site Number 124023

    Calgary, T2H 2G4

  • Investigational Site Number 124020

    Calgary, T2N 4L7

  • Investigational Site Number 124019

    Chatham, N7L 1C1

  • Investigational Site Number 124018

    Coquitlam, V3K 3P4

  • Investigational Site Number 124021

    Hamilton, L8L 5G8

  • Investigational Site Number 124014

    Hamilton, L8N 3Z5

  • Investigational Site Number 124006

    Laval, H7T 2P5

  • Investigational Site Number 124009

    London, N6A 4V2

  • Investigational Site Number 124008

    Mississauga, L5M 2V8

  • Investigational Site Number 124015

    Montreal, H2W 1R7

  • Investigational Site Number 124004

    Montreal, H2W 1T8

  • Investigational Site Number 124005

    Oshawa, L1H 7K4

  • Investigational Site Number 124026

    Québec, G1V 4G5

  • Investigational Site Number 124002

    Red Deer, T4N 6V7

  • Investigational Site Number 124017

    Saint-Laurent, H4T 1Z9

  • Investigational Site Number 124007

    Thornhill, L4J 8L7

  • Investigational Site Number 124001

    Toronto, M4G 3E8

  • Investigational Site Number 124011

    Toronto, M5C 2T2

  • Investigational Site Number 124010

    Victoria, V8V 4A1

  • Investigational Site Number 124022

    Winnipeg, R3E 3P4

Other trials in Canada

Hungary17 sites

  • Investigational Site Number 348010

    Baja, 6500

  • Investigational Site Number 348004

    Balatonfüred, 8230

  • Investigational Site Number 348015

    Budapest, 1083

  • Investigational Site Number 348013

    Budapest, 1088

  • Investigational Site Number 348017

    Budapest, 1134

  • Investigational Site Number 348009

    Budapest, 1139

  • Investigational Site Number 348002

    Budapest

  • Investigational Site Number 348005

    Debrecen, 4043

  • Investigational Site Number 348008

    Eger, 3300

  • Investigational Site Number 348018

    Gyula, 5700

  • Investigational Site Number 348014

    Makó, 6900

  • Investigational Site Number 348012

    Mosonmagyaróvár, 9200

  • Investigational Site Number 348007

    Nyiregyháza, 4400

  • Investigational Site Number 348011

    Sátorlaljaújhely, 3980

  • Investigational Site Number 348003

    Szeged, 6722

  • Investigational Site Number 348006

    Szombathely, 9700

  • Investigational Site Number 348001

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia10 sites

  • Investigational Site Number 203006

    Beroun, 26601

  • Investigational Site Number 203001

    Břeclav, 690 02

  • Investigational Site Number 203002

    Hodonín, 69501

  • Investigational Site Number 203009

    Holešov, 76901

  • Investigational Site Number 203003

    Hradec Králové, 50005

  • Investigational Site Number 203007

    Hranice, 75301

  • Investigational Site Number 203004

    Krnov, 79401

  • Investigational Site Number 203010

    Olomouc, 77900

  • Investigational Site Number 203008

    Prague, 12808

  • Investigational Site Number 203005

    Prostějov, 79601

Other trials in Czechia

Romania9 sites

  • Investigational Site Number 642001

    Bacau, 600114

  • Investigational Site Number 642005

    Bucharest, 020475

  • Investigational Site Number 642006

    Bucharest, 700164

  • Investigational Site Number 642002

    Cluj-Napoca, 400006

  • Investigational Site Number 642004

    Iași, 700547

  • Investigational Site Number 642008

    Iași, 700613

  • Investigational Site Number 642003

    Oradea, 410169

  • Investigational Site Number 642009

    Târgu Mureş, 540142

  • Investigational Site Number 642007

    Timișoara, 300133

Other trials in Romania

Netherlands8 sites

  • Investigational Site Number 528009

    Almelo, 7609 PP

  • Investigational Site Number 528004

    Eindhoven, 5631 BM

  • Investigational Site Number 528007

    Groningen, 9728 NT

  • Investigational Site Number 528005

    Hoogeveen, 7909 AA

  • Investigational Site Number 528001

    Hoorn, 1064NP

  • Investigational Site Number 528008

    Leeuwarden, 8934 AD

  • Investigational Site Number 528006

    Utrecht, 3563 AZ

  • Investigational Site Number 528002

    Venlo, 5912 BL

Other trials in Netherlands

South Africa7 sites

  • Investigational Site Number 710005

    Alberton, 1450

  • Investigational Site Number 710003

    Johannesburg, 2198

  • Investigational Site Number 710006

    Lenasia, 1820

  • Investigational Site Number 710002

    Observatory, 7925

  • Investigational Site Number 710001

    Paarl, 7500

  • Investigational Site Number 710008

    Pretoria, 0167

  • Investigational Site Number 710004

    Somerset West, 7130

Other trials in South Africa

Estonia6 sites

  • Investigational Site Number 233002

    Pärnu, 80018

  • Investigational Site Number 233004

    Tallinn, 11313

  • Investigational Site Number 233006

    Tallinn, 11913

  • Investigational Site Number 233003

    Tallinn, 13415

  • Investigational Site Number 233001

    Tallinn, 13419

  • Investigational Site Number 233005

    Tartu, 50410

Other trials in Estonia

Latvia6 sites

  • Investigational Site Number 428006

    Jēkabpils, LV-5201

  • Investigational Site Number 428005

    Ogre, LV-5001

  • Investigational Site Number 428002

    Riga, LV-1002

  • Investigational Site Number 428001

    Riga, LV-1038

  • Investigational Site Number 428004

    Riga, LV-1050

  • Investigational Site Number 428003

    Sigulda, LV-2150

Other trials in Latvia

Mexico5 sites

  • Investigational Site Number 484007

    Chihuahua City, 31000

  • Investigational Site Number 484001

    Cuernavaca, 62250

  • Investigational Site Number 484006

    Guadalajara, 44670

  • Investigational Site Number 484003

    Monterrey, 64460

  • Investigational Site Number 484004

    Pachuca, 42060

Other trials in Mexico

Finland3 sites

  • Investigational Site Number 246001

    Helsinki, 00260

  • Investigational Site Number 246005

    Kuopio, 70210

  • Investigational Site Number 246002

    Oulu, 90100

Other trials in Finland

Germany3 sites

  • Investigational Site Number 276006

    Heidelberg, 69115

  • Investigational Site Number 276002

    Riesa, 01587

  • Investigational Site Number 276003

    Schwabenheim, 55270

Other trials in Germany

France2 sites

  • Investigational Site Number 250004

    La Rochelle, 17019

  • Investigational Site Number 250002

    Strasbourg, 67091

Other trials in France

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® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Primary Objective:

  • To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

  • To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia
Read the detailed description

The maximum study duration was up to approximately 58 weeks per participant, consisting of:

  • up to 2 week screening period
  • 6-month comparative efficacy and safety treatment period
  • 6-month comparative safety extension period
  • 4-week safety follow-up period in a subset of participants
  • a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
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 mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.

  • 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 mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Study groups in NCT01499082
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

    Measured: Baseline, Month 6

Secondary outcomes (10)

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

    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]).

    Measured: Week 9 Up to Month 6

  2. Change in Average 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. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.

    Measured: Baseline, Month 6

  3. Change in Variability of Preinjection SMPG From Baseline to 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.

    Measured: Baseline, Month 6

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

    Measured: Month 6

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

    Measured: Baseline, Month 6

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

    Measured: Month 6

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

    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.

    Measured: Baseline, Month 6

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

    Measured: Baseline, Month 6

  9. Change in 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.

    Measured: Baseline, Month 6

  10. 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 Month 12

Timeline

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

  1. First posted26 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJan 2013
  4. Study completionSep 2013

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
807 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01499082
Sponsor's protocol ID
EFC11628
Other IDs
2010-023769-23
Acronym
EDITION I
Status last verified
Mar 2022
First submitted
16 Dec 2011
Last updated
25 Mar 2022
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.

    PubMed 25078900

  • 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

  • Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.

    PubMed 29649539

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 193 sites in 13 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 4 inclusion and 13 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Canada, Hungary, Czechia, Romania and 8 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 NCT01499082, which also lists 3 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 25 Mar 2022.

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