Type 2 Diabetes MellitusPhase 3EDITION IINCT01499095
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
A Phase 3 study testing Lantus (Insulin glargine) and HOE901-U300 (new formulation of insulin glargine) in people with Type 2 Diabetes Mellitus, run by Sanofi at 213 sites in 13 countries.
Trial summary
Primary Objective: To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: To compare the efficacy of insulin glargine new… 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?
- Lantus (Insulin glargine) and HOE901-U300 (new formulation of insulin glargine)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811 participants
- Where
- 213 sitesin 13 countries
- Study dates
- Dec 2011to Nov 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 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
- Participants using sulfonylurea in the last 2 months before screening visit
- Any contraindication to use of insulin glargine as defined in the national product label
Show all 13Show fewer
- Use of insulin pump in the last 6 months before screening
- Initiation of new glucose-lowering medications 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
213 sites in 13 countries.
213 sites in 13 countries
United States110 sites
Investigational Site Number 840074
Anaheim, California, 92801
Investigational Site Number 840063
Ann Arbor, Michigan, 48106
Investigational Site Number 840022
Austin, Texas, 78731
Investigational Site Number 840078
Austin, Texas, 78758
Investigational Site Number 840045
Avon, Indiana, 46123
Investigational Site Number 840077
Avon, Indiana, 46123
Investigational Site Number 840088
Avon, Indiana, 46123
Investigational Site Number 840089
Avon, Indiana, 46123
Investigational Site Number 840091
Avon, Indiana, 46123
Investigational Site Number 840034
Baltimore, Maryland, 21237
Investigational Site Number 840150
Baltimore, Maryland, 21237
Investigational Site Number 840509
Bell Gardens, California, 90201
Investigational Site Number 840158
Biloxi, Mississippi, 39531
Investigational Site Number 840517
Birmingham, Alabama, 35213
Investigational Site Number 840518
Brandon, Florida, 33511
Investigational Site Number 840028
Bristol, Tennessee, 37620
Investigational Site Number 840502
Butte, Montana, 59701
Investigational Site Number 840140
Calabash, North Carolina, 28467
Investigational Site Number 840149
Chandler, Arizona, 85224
Investigational Site Number 840038
Chattanooga, Tennessee, 37404
Investigational Site Number 840032
Chesapeake, Virginia, 23321
Investigational Site Number 840526
Chesterfield, Missouri, 63017
Investigational Site Number 840199
Chicago, Illinois, 60612
Investigational Site Number 840007
Cincinnati, Ohio, 45236
Investigational Site Number 840104
Colorado Springs, Colorado, 80906
Investigational Site Number 840128
Colorado Springs, Colorado, 80909
Investigational Site Number 840528
Columbus, Georgia, 31901
Investigational Site Number 840097
Columbus, Ohio, 43213
Investigational Site Number 840519
Corpus Christi, Texas, 78404
Investigational Site Number 840001
Dallas, Texas, 75230
Investigational Site Number 840159
Dallas, Texas, 75231
Investigational Site Number 840115
Dallas, Texas, 75246
Investigational Site Number 840113
Dayton, Ohio, 45439
Investigational Site Number 840049
Daytona Beach, Florida, 32117
Investigational Site Number 840064
Dearborn, Michigan, 48124
Investigational Site Number 840098
Denver, Colorado, 80206
Investigational Site Number 840009
Draper, Utah, 84020
Investigational Site Number 840066
Eagan, Minnesota, 55122
Investigational Site Number 840504
Eugene, Oregon
Investigational Site Number 840130
Evansville, Indiana, 47714
Investigational Site Number 840065
Fargo, North Dakota, 58103
Investigational Site Number 840094
Flint, Michigan, 48504
Investigational Site Number 840084
Fremont, Nebraska, 68025
Investigational Site Number 840093
Glendale, Arizona, 85306
Investigational Site Number 840060
Greenbrae, California, 94904
Investigational Site Number 840076
Greer, South Carolina, 29651
Investigational Site Number 840139
Hickory, North Carolina, 28601
Investigational Site Number 840153
Hickory, North Carolina, 28601
Investigational Site Number 840015
Hot Springs, Arkansas, 71913
Investigational Site Number 840079
Houston, Texas, 77030
Investigational Site Number 840514
Houston, Texas, 77074
Investigational Site Number 840050
Idaho Falls, Idaho, 83404
Investigational Site Number 840008
Jacksonville, Florida, 32258
Investigational Site Number 840042
Knoxville, Tennessee, 37912
Investigational Site Number 840057
La Jolla, California, 92037
Investigational Site Number 840003
La Mesa, California, 91942
Investigational Site Number 840142
Lafayette, Indiana, 47904
Investigational Site Number 840162
Las Vegas, Nevada, 89102
Investigational Site Number 840527
Las Vegas, Nevada, 89117
Investigational Site Number 840056
Las Vegas, Nevada, 89148
Investigational Site Number 840014
Little Rock, Arkansas, 72205
Investigational Site Number 840114
Little Rock, Arkansas, 72205
Investigational Site Number 840026
Los Angeles, California, 90073
Investigational Site Number 840108
Maumee, Ohio, 43537
Investigational Site Number 840021
McHenry, Illinois, 60050
Investigational Site Number 840080
Medford, Oregon, 97504
Investigational Site Number 840160
Memphis, Tennessee, 38119
Investigational Site Number 840033
Memphis, Tennessee, 38125
Investigational Site Number 840520
Miami, Florida, 33015
Investigational Site Number 840019
Milwaukee, Wisconsin, 53209-0996
Investigational Site Number 840081
Minneapolis, Minnesota, 55416
Investigational Site Number 840090
Mission Hills, California, 91345
Investigational Site Number 840018
Mountain Home, Arkansas, 72653
Investigational Site Number 840107
Nampa, Idaho, 83686
Investigational Site Number 840025
New Port Richey, Florida, 34652
Investigational Site Number 840040
Norfolk, Virginia, 23510
Investigational Site Number 840011
Ocoee, Florida, 34761
Investigational Site Number 840523
Olympia, Washington, 98502
Investigational Site Number 840085
Omaha, Nebraska, 68130
Investigational Site Number 840037
Orem, Utah, 84058
Investigational Site Number 840041
Paducah, Kentucky, 42003
Investigational Site Number 840141
Palm Harbor, Florida, 34684
Investigational Site Number 840099
Palm Springs, California, 92262
Investigational Site Number 840513
Pembroke Pines, Florida, 33029
Investigational Site Number 840069
Phoenix, Arizona, 85028
Investigational Site Number 840048
Rapid City, South Dakota, 57701
Investigational Site Number 840095
Richmond, Virginia, 23235
Investigational Site Number 840031
Rockville, Maryland, 20852
Investigational Site Number 840510
Salt Lake City, Utah, 84107
Investigational Site Number 840525
San Antonio, Texas, 78229
Investigational Site Number 840161
San Antonio, Texas, 78258
Investigational Site Number 840004
San Diego, California, 92161
Investigational Site Number 840124
Santa Barbara, California, 93110
Investigational Site Number 840027
Searcy, Arkansas, 72143
Investigational Site Number 840503
Simpsonville, South Carolina, 29681
Investigational Site Number 840023
Southfield, Michigan, 48034
Investigational Site Number 840020
Springfield, Illinois, 62704
Investigational Site Number 840135
Summit, New Jersey, 07901
Investigational Site Number 840110
Sun City, Arizona, 85351
Investigational Site Number 840068
Tempe, Arizona, 85282
Investigational Site Number 840148
Tipton, Pennsylvania, 16684
Investigational Site Number 840145
Toms River, New Jersey, 08721
Investigational Site Number 840087
Toms River, New Jersey, 08753
Investigational Site Number 840012
Tustin, California, 92780
Investigational Site Number 840005
Uniontown, Pennsylvania, 15401
Investigational Site Number 840122
Walla Walla, Washington, 99362
Investigational Site Number 840072
Williamsburg, Virginia, 23185
Investigational Site Number 840047
Wilmington, North Carolina, 28401
Investigational Site Number 840134
Winchester, Virginia, 22601
Investigational Site Number 840024
Winston-Salem, North Carolina, 27103
Romania15 sites
Investigational Site Number 642008
Bacau, 600164
Investigational Site Number 642009
Brasov, 500365
Investigational Site Number 642003
Bucharest, 020475
Investigational Site Number 642001
Bucharest, 20475
Investigational Site Number 642002
Bucharest, 20475
Investigational Site Number 642014
Cluj-Napoca, 400006
Investigational Site Number 642006
Deva, 330084
Investigational Site Number 642011
Hunedoara, 331057
Investigational Site Number 642015
Iași, 700547
Investigational Site Number 642013
Oradea, 410169
Investigational Site Number 642010
Ploieşti, 100097
Investigational Site Number 642004
Reşiţa, 320076
Investigational Site Number 642007
Târgu Mureş, 540142
Investigational Site Number 642012
Timișoara, 300133
Investigational Site Number 642005
Timișoara, 300456
Canada14 sites
Investigational Site Number 124024
Beamsville, L0R 1B0
Investigational Site Number 124025
Burlington, L7M 4Y1
Investigational Site Number 124020
Calgary, T2N 4L7
Investigational Site Number 124019
Chilliwack, V2P 4M9
Investigational Site Number 124018
Coquitlam, V3K 3P4
Investigational Site Number 124016
Edmonton, T5C 0A3
Investigational Site Number 124014
Hamilton, L8N 3Z5
Investigational Site Number 124004
Mirabel, J7J 2K8
Investigational Site Number 124026
Mississauga, L5M 2V8
Investigational Site Number 124002
Red Deer, T4N 6V7
Investigational Site Number 124013
Sherbrooke, J1H 5N4
Investigational Site Number 124011
Toronto, M5C 2T2
Investigational Site Number 124010
Victoria, V8V 4A1
Investigational Site Number 124022
Winnipeg, R3E 3P4
Russia13 sites
Investigational Site Number 643010
Moscow, 123423
Investigational Site Number 643007
Moscow, 129110
Investigational Site Number 643009
Saint Petersburg, 194291
Investigational Site Number 643006
Saint Petersburg, 194354
Investigational Site Number 643014
Saint Petersburg, 194354
Investigational Site Number 643008
Saint Petersburg, 194358
Investigational Site Number 643013
Saint Petersburg, 195112
Investigational Site Number 643004
Saint Petersburg, 195257
Investigational Site Number 643001
Saint Petersburg, 198013
Investigational Site Number 643011
Samara, 443095
Investigational Site Number 643002
Saratov, 410030
Investigational Site Number 643016
Ufa, 450000
Investigational Site Number 643005
Voronezh, 394018
Chile12 sites
Investigational Site Number 152014
Osorno, 5311092
Investigational Site Number 152012
Rancagua, 2841959
Investigational Site Number 152005
Santiago, 7500010
Investigational Site Number 152004
Santiago, 7500710
Investigational Site Number 152003
Santiago, 751-0009
Investigational Site Number 152001
Santiago, 7980378
Investigational Site Number 152013
Santiago, 7980378
Investigational Site Number 152002
Santiago, 80004005
Investigational Site Number 152007
Santiago, 8053095
Investigational Site Number 152010
Santiago
Investigational Site Number 152006
Temuco, 4813299
Investigational Site Number 152009
Valdivia, 56 63
Hungary10 sites
Investigational Site Number 348006
Baja, 6500
Investigational Site Number 348005
Budapest, 1032
Investigational Site Number 348003
Budapest, 1139
Investigational Site Number 348010
Budapest, 1145
Investigational Site Number 348009
Budapest, 1204
Investigational Site Number 348002
Eger, 3300
Investigational Site Number 348001
Makó, 6900
Investigational Site Number 348008
Mosonmagyaróvár, 9200
Investigational Site Number 348004
Pápa, 8500
Investigational Site Number 348007
Sátorlaljaújhely, 3980
South Africa10 sites
Investigational Site Number 710007
Benoni, 1501
Investigational Site Number 710006
Bloemfontein, 9301
Investigational Site Number 710014
Bloemfontein, 9301
Investigational Site Number 710002
Boksburg, 1459
Investigational Site Number 710003
Cape Town, 7130
Investigational Site Number 710010
Cape Town, 7500
Investigational Site Number 710008
eMkhomazi, 4170
Investigational Site Number 710001
Johannesburg, 2013
Investigational Site Number 710005
Pretoria, 0001
Investigational Site Number 710012
Somerset West, 7130
Mexico8 sites
Investigational Site Number 484009
Acapulco, 39670
Investigational Site Number 484007
Guadalajara, 44210
Investigational Site Number 484008
Guadalajara, 44656
Investigational Site Number 484010
Guadalajara, Guadalajara
Investigational Site Number 484006
Mexico City, 11550
Investigational Site Number 484001
Monterrey, 64020
Investigational Site Number 484003
Monterrey, 64240
Investigational Site Number 484004
Pachuca, 42060
France6 sites
Investigational Site Number 250001
La Rochelle, 17019
Investigational Site Number 250004
Le Creusot, 71200
Investigational Site Number 250005
Mantes-la-Jolie, 78200
Investigational Site Number 250002
Nantes, 44093
Investigational Site Number 250009
Strasbourg, 67000
Investigational Site Number 250003
Vénissieux, 69200
Germany6 sites
Investigational Site Number 276004
Künzing, 94550
Investigational Site Number 276003
Neumünster, 24534
Investigational Site Number 276008
Oberhausen, 46045
Investigational Site Number 276009
Pirna, 01796
Investigational Site Number 276007
Rehlingen-Siersburg, 66780
Investigational Site Number 276005
Wangen, 88239
Spain6 sites
Investigational Site Number 724005
Barcelona, 08022
Investigational Site Number 724003
Málaga, 29010
Investigational Site Number 724006
Palma de Mallorca, 07198
Investigational Site Number 724001
Sabadell, 08208
Investigational Site Number 724002
Seville, 41010
Investigational Site Number 724004
Valancia, 46014
Portugal2 sites
Investigational Site Number 620007
Matosinhos Municipality
Investigational Site Number 620004
Porto, 4200
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 in Combination With Oral Antihyperglycemic Drug(s) 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 Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus
Secondary Objective:
- 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 participants, 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
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Lantus (Insulin glargine), HOE901-U300 (new formulation of 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.
Lantus (Insulin glargine)Drug
Also called Lantus
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
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 in combination with oral antidiabetic drug(s). 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.
| Study group | Role | What they receive |
|---|---|---|
| HOE901-U300 | Experimental | Not described Receives: Drug: HOE901-U300 (new formulation of insulin glargine) |
| Lantus | Active comparator | Not described Receives: Drug: Lantus (Insulin glargine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
Secondary outcomes (10)
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 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Week 9 Up to Month 6
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Preinjection 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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient 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 measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Month 6
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Month 6
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
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. Only measurements performed before initiation of rescue therapy were considered in the analysis.
Measured: Baseline, Month 6
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.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499095
- Sponsor's protocol ID
- EFC11629
- Other IDs
- 2010-023770-39, U1111-1118-6943
- Acronym
- EDITION II
- Status last verified
- Mar 2022
- First submitted
- 16 Dec 2011
- Last updated
- 23 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Yki-Jarvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, Riddle MC; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.
PubMed 25193531Yale 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 30366067Bolli 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 30160030Bonadonna 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 29649539Yale 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 29370218Yki-Jarvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, Maroccia M, Riddle MC. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015 Dec;17(12):1142-9. doi: 10.1111/dom.12532. Epub 2015 Sep 14.
PubMed 26172084
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period
- ClinicalTrials.gov ID
- NCT01499095
- Acronym / sponsor ID
- EDITION II / EFC11629
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 23 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus
Secondary Objective:
- To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia
Detailed description
The maximum study duration was up to approximately 58 weeks per participants, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOE901-U300 | Experimental | Drug: HOE901-U300 (new formulation of insulin glargine) |
| Lantus | Active comparator | Drug: Lantus (Insulin glargine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with type 2 diabetes mellitus
- Substudy inclusion criteria:
Key exclusion criteria (13 listed)
- Age less than (<) 18 years
- HbA1c <7.0% or greater than (>) 10% at screening
- Diabetes other than type 2 diabetes mellitus
- Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
- Participants using sulfonylurea in the last 2 months before screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lantus (Insulin glargine)Also: LantusLantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL). | Drug | Lantus |
| 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 in combination with oral antidiabetic drug(s). 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. | Drug | HOE901-U300 |
Primary outcome
Change in HbA1c From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Only measurements performed before initiation of rescue therapy were considered in the analysis.
10 secondary outcomes
Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Time frame: Week 9 Up to Month 6
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Percentage of Participants With HbA1c <7% at Month 6 Endpoint
Time frame: Month 6
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint
Time frame: Month 6
Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint
Time frame: Baseline, Month 6
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12
Time frame: Up to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25193531Yki-Jarvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, Riddle MC; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.
- Derived from this study: PubMed 30366067Yale 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.
- Derived from this study: PubMed 30160030Bolli 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.
- Derived from this study: PubMed 29649539Bonadonna 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.
- Derived from this study: PubMed 29370218Yale 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.
- Derived from this study: PubMed 26172084Yki-Jarvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, Maroccia M, Riddle MC. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015 Dec;17(12):1142-9. doi: 10.1111/dom.12532. Epub 2015 Sep 14.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
213 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lantus (Insulin glargine) and HOE901-U300 (new formulation of insulin glargine) in people with Type 2 Diabetes Mellitus, run by Sanofi at 213 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 23 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 213 sites in United States, Romania, Canada, Russia, Chile 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 NCT01499095, which also lists 6 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 23 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.