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Type 1 Diabetes MellitusPhase 3EDITION IVNCT01683266

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

A Phase 3 study testing HOE901-U300 (Insulin glargine new formulation) and Lantus (Insulin glargine) in people with Type 1 Diabetes Mellitus, run by Sanofi at 147 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 a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus Secondary Objective: To compare HOE901-U300 and Lantus when… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
HOE901-U300 (Insulin glargine new formulation) and Lantus (Insulin glargine)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
147 sitesin 13 countries
Study dates
Sep 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 1 diabetes mellitus

Who cannot join

  • HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at screening
  • Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
  • Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
  • Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
  • Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
  • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
Show all 9Show fewer
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (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

147 sites in 13 countries.

147 sites in 13 countries

United States82 sites

  • Investigational Site Number 840151

    Albuquerque, New Mexico, 87106

  • Investigational Site Number 840133

    Asheville, North Carolina, 28803

  • Investigational Site Number 840195

    Atlanta, Georgia, 30318

  • Investigational Site Number 840109

    Austin, Texas, 78731

  • Investigational Site Number 840157

    Austin, Texas, 78731

  • Investigational Site Number 840172

    Avon, Indiana, 46123

  • Investigational Site Number 840104

    Baltimore, Maryland, 21237

  • Investigational Site Number 840430

    Bell Gardens, California, 90201

  • Investigational Site Number 840112

    Bend, Oregon, 97701

  • Investigational Site Number 840113

    Bradenton, Florida, 34208

  • Investigational Site Number 840125

    Burke, Virginia, 22015

  • Investigational Site Number 840156

    Chandler, Arizona, 85224

  • Investigational Site Number 840175

    Chapel Hill, North Carolina, 27599-7295

  • Investigational Site Number 840144

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840427

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840122

    Dakota Dunes, South Dakota, 57049

  • Investigational Site Number 840150

    Dallas, Texas, 75230

  • Investigational Site Number 840412

    Dallas, Texas, 75231

  • Investigational Site Number 840160

    Denver, Colorado, 80239

  • Investigational Site Number 840188

    Denver, Colorado, 80262

  • Investigational Site Number 840108

    Des Moines, Iowa, 50314

  • Investigational Site Number 840408

    Detroit, Michigan, 48202

  • Investigational Site Number 840131

    Escondido, California, 92025

  • Investigational Site Number 840140

    Fresno, California, 93720

  • Investigational Site Number 840107

    Greenbrae, California, 94904

  • Investigational Site Number 840136

    Greer, South Carolina, 29651

  • Investigational Site Number 840137

    Haverhill, Massachusetts, 1830

  • Investigational Site Number 840102

    Hialeah, Florida, 33012

  • Investigational Site Number 840134

    Hollywood, Florida, 33021

  • Investigational Site Number 840124

    Honolulu, Hawaii, 96814

  • Investigational Site Number 840130

    Houston, Texas, 77030

  • Investigational Site Number 840141

    Houston, Texas, 77095

  • Investigational Site Number 840149

    Huntington Beach, California, 92648

  • Investigational Site Number 840167

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840197

    Indianapolis, Indiana, 46202

  • Investigational Site Number 840407

    Iowa City, Iowa

  • Investigational Site Number 840185

    Jacksonville, Florida, 32216

  • Investigational Site Number 840116

    Jacksonville, Florida, 32258

  • Investigational Site Number 840120

    La Jolla, California, 92037

  • Investigational Site Number 840123

    La Mesa, California, 91942

  • Investigational Site Number 840159

    La Mesa, California, 91942

  • Investigational Site Number 840139

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840421

    Lexington, Kentucky, 40503

  • Investigational Site Number 840177

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840114

    Long Beach, California, 90806

  • Investigational Site Number 840153

    Madison Heights, Michigan, 48071

  • Investigational Site Number 840103

    Manassas, Virginia, 20110

  • Investigational Site Number 840169

    Mentor, Ohio, 44060

  • Investigational Site Number 840426

    Metairie, Louisiana, 70006

  • Investigational Site Number 840126

    Miami, Florida, 33144

  • Investigational Site Number 840179

    Miami, Florida, 33176

  • Investigational Site Number 840411

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840189

    Mission Hills, California, 91345

  • Investigational Site Number 840161

    Morganton, North Carolina, 28655

  • Investigational Site Number 840101

    Murray, Utah, 84123

  • Investigational Site Number 840163

    Nampa, Idaho, 83686

  • Investigational Site Number 840187

    Nashville, Tennessee, 37232

  • Investigational Site Number 840196

    New Haven, Connecticut, 06520

  • Investigational Site Number 840191

    New Hyde Park, New York, 11042

  • Investigational Site Number 840117

    New Port Richey, Florida, 34652

  • Investigational Site Number 840119

    Norman, Oklahoma, 73069

  • Investigational Site Number 840106

    Omaha, Nebraska, 68131

  • Investigational Site Number 840145

    Omaha, Nebraska, 68131

  • Investigational Site Number 840174

    Orlando, Florida, 32806

  • Investigational Site Number 840110

    Oviedo, Florida, 32765

  • Investigational Site Number 840178

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840132

    Renton, Washington, 98055

  • Investigational Site Number 840180

    Rockville, Maryland, 20852

  • Investigational Site Number 840171

    Saint Louis Park, Minnesota, 55416

  • Investigational Site Number 840166

    San Antonio, Texas, 78229

  • Investigational Site Number 840403

    Seattle, Washington, 98195

  • Investigational Site Number 840402

    Spokane, Washington, 99220

  • Investigational Site Number 840162

    Springfield, Illinois, 62704

  • Investigational Site Number 840184

    St Louis, Missouri, 63110

  • Investigational Site Number 840173

    Syracuse, New York, 13210

  • Investigational Site Number 840127

    Tacoma, Washington, 98415-0299

  • Investigational Site Number 840181

    Tampa, Florida, 33613

  • Investigational Site Number 840105

    Temecula, California, 92591

  • Investigational Site Number 840170

    Topeka, Kansas, 66606

  • Investigational Site Number 840155

    Tustin, California, 92780

  • Investigational Site Number 840115

    Walnut Creek, California, 94598

  • Investigational Site Number 840420

    West Palm Beach, Florida, 33401

Other trials in United States

Japan11 sites

  • Investigational Site Number 392110

    Aisai

  • Investigational Site Number 392105

    Ise-Shi

  • Investigational Site Number 392104

    Karatsu-Shi

  • Investigational Site Number 392111

    Kitakyushu-Shi

  • Investigational Site Number 392108

    Matsumoto

  • Investigational Site Number 392112

    Matsumoto-Shi

  • Investigational Site Number 392103

    Midori

  • Investigational Site Number 392107

    Mito

  • Investigational Site Number 392101

    Sakaishi

  • Investigational Site Number 392102

    Tomishiro

  • Investigational Site Number 392106

    Yamagata

Other trials in Japan

Romania9 sites

  • Investigational Site Number 642107

    Bacau, 600164

  • Investigational Site Number 642103

    Brasov, 500365

  • Investigational Site Number 642109

    Oradea, 410169

  • Investigational Site Number 642106

    Reşiţa, 320076

  • Investigational Site Number 642104

    Sibiu, 550371

  • Investigational Site Number 642101

    Târgu Mureş, 540142

  • Investigational Site Number 642102

    Târgu Mureş, 540142

  • Investigational Site Number 642105

    Timișoara, 300133

  • Investigational Site Number 642108

    Timișoara, 300456

Other trials in Romania

Canada6 sites

  • Investigational Site Number 124110

    Coquitlam, V3K 3P4

  • Investigational Site Number 124104

    Laval, H7T 2P5

  • Investigational Site Number 124108

    Mirabel, J7J 2K8

  • Investigational Site Number 124109

    Montreal, H1Y 3L1

  • Investigational Site Number 124105

    Thornhill, L4J 8L7

  • Investigational Site Number 124101

    Toronto, M4R 2G4

Other trials in Canada

Hungary6 sites

  • Investigational Site Number 348103

    Budapest, 1036

  • Investigational Site Number 348108

    Budapest, 1083

  • Investigational Site Number 348107

    Budapest, 1088

  • Investigational Site Number 348106

    Debrecen, 4031

  • Investigational Site Number 348102

    Gyula, 5700

  • Investigational Site Number 348101

    Úrhida, 8142

Other trials in Hungary

Denmark5 sites

  • Investigational Site Number 208102

    Aalborg, 9100

  • Investigational Site Number 208103

    Esbjerg, 6700

  • Investigational Site Number 208105

    Gentofte Municipality, 2900

  • Investigational Site Number 208104

    København NV, 2400

  • Investigational Site Number 208107

    Køge, 4600

Other trials in Denmark

Estonia5 sites

  • Investigational Site Number 233104

    Pärnu, 80018

  • Investigational Site Number 233105

    Tallinn, 13419

  • Investigational Site Number 233106

    Tartu, 50406

  • Investigational Site Number 233101

    Tartu, 50410

  • Investigational Site Number 233103

    Viljandimaa, 71024

Other trials in Estonia

Finland5 sites

  • Investigational Site Number 246102

    Kokkola, 67100

  • Investigational Site Number 246101

    Kuopio, 70210

  • Investigational Site Number 246106

    Loimaa, 32200

  • Investigational Site Number 246105

    Oulu, 90100

  • Investigational Site Number 246103

    Tampere, 33100

Other trials in Finland

Latvia5 sites

  • Investigational Site Number 428106

    Limbaži, LV-4001

  • Investigational Site Number 428103

    Riga, LV-1002

  • Investigational Site Number 428105

    Riga, LV-1050

  • Investigational Site Number 428102

    Sigulda, LV-2150

  • Investigational Site Number 428101

    Ventspils, LV-3601

Other trials in Latvia

Netherlands5 sites

  • Investigational Site Number 528101

    Almere Stad, 1311 RL

  • Investigational Site Number 528103

    Beek, 6191 JW

  • Investigational Site Number 528105

    Nijmegen, 6525 GA

  • Investigational Site Number 528104

    Venlo, 5912 BL

  • Investigational Site Number 528102

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Sweden4 sites

  • Investigational Site Number 752103

    Gothenburg, 41345

  • Investigational Site Number 752105

    Kristianstad, 29185

  • Investigational Site Number 752101

    Stockholm, 11526

  • Investigational Site Number 752104

    Vällingby, 16268

Other trials in Sweden

Czechia3 sites

  • Investigational Site Number 203102

    Brno, 62500

  • Investigational Site Number 203104

    Prague, 10034

  • Investigational Site Number 203103

    Prague, 18100

Other trials in Czechia

Puerto Rico1 site

  • Investigational Site Number 840602

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Primary Objective:

  • To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus
Read more

Secondary Objective:

  • To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
  • Change of HbA1c from baseline to endpoint (scheduled Month 6)
  • Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
  • Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
  • Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
  • Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
Read the detailed description

The maximum study duration was up to approximately 54 weeks per participants:

  • Up to 2-week screening period
  • 6-month open-label comparative efficacy and safety treatment period
  • 6-month open-label comparative safety extension period
  • 48-hour post-treatment safety follow-up period
Being tested
HOE901-U300 (Insulin glargine new formulation), Lantus (Insulin glargine)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • HOE901-U300 (Insulin glargine new formulation)Drug

  • Lantus (Insulin glargine)Drug

Study groups in NCT01683266
Study groupRoleWhat they receive
HOE901-U300ExperimentalHOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or 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]).
Receives: Drug: HOE901-U300 (Insulin glargine new formulation)
LantusActive comparatorLantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or 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).
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 (11)

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

    Measured: Month 6

  2. Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint

    Measured: Month 6

  3. Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline 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

  4. Change in Variability of Pre-injection 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

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

    Measured: Baseline, Month 6

  6. Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6

    Measured: Month 6

  7. Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint

    Measured: Month 6

  8. 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

  9. Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint

    Measured: Baseline, Month 6

  10. 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.

    Measured: Baseline, Month 6

  11. Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline 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 posted11 Sep 2012 (estimated)
  2. Study startSep 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
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683266
Sponsor's protocol ID
EFC12456
Other IDs
2012-001524-35, U1111-1128-5517
Acronym
EDITION IV
Status last verified
May 2015
First submitted
7 Sep 2012
Last updated
24 Jun 2015
Data monitoring committee
No

Publications

  • Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, Riddle MC. Glycaemic control and hypoglycaemia during 12 months of randomized treatment with insulin glargine 300 U/mL versus glargine 100 U/mL in people with type 1 diabetes (EDITION 4). Diabetes Obes Metab. 2018 Jan;20(1):121-128. doi: 10.1111/dom.13048. Epub 2017 Aug 8.

    PubMed 28661585

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HOE901-U300 (Insulin glargine new formulation) and Lantus (Insulin glargine) in people with Type 1 Diabetes Mellitus, run by Sanofi at 147 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 1 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 147 sites in United States, Japan, Romania, Canada, Hungary 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 NCT01683266, which also lists 1 linked publication.

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.

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