Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
NCT ID: NCT01499095
Last Updated: 2022-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
811 participants
INTERVENTIONAL
2011-12-31
2013-11-30
Brief Summary
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* 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
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HOE901-U300
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.
Lantus
Lantus (Insulin glargine)
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).
Interventions
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Lantus (Insulin glargine)
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)
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.
Other Intervention Names
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Eligibility Criteria
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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)
Exclusion Criteria
* 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
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840517
Birmingham, Alabama, United States
Investigational Site Number 840149
Chandler, Arizona, United States
Investigational Site Number 840093
Glendale, Arizona, United States
Investigational Site Number 840069
Phoenix, Arizona, United States
Investigational Site Number 840110
Sun City, Arizona, United States
Investigational Site Number 840068
Tempe, Arizona, United States
Investigational Site Number 840015
Hot Springs, Arkansas, United States
Investigational Site Number 840014
Little Rock, Arkansas, United States
Investigational Site Number 840114
Little Rock, Arkansas, United States
Investigational Site Number 840018
Mountain Home, Arkansas, United States
Investigational Site Number 840027
Searcy, Arkansas, United States
Investigational Site Number 840074
Anaheim, California, United States
Investigational Site Number 840509
Bell Gardens, California, United States
Investigational Site Number 840060
Greenbrae, California, United States
Investigational Site Number 840057
La Jolla, California, United States
Investigational Site Number 840003
La Mesa, California, United States
Investigational Site Number 840026
Los Angeles, California, United States
Investigational Site Number 840090
Mission Hills, California, United States
Investigational Site Number 840099
Palm Springs, California, United States
Investigational Site Number 840004
San Diego, California, United States
Investigational Site Number 840124
Santa Barbara, California, United States
Investigational Site Number 840012
Tustin, California, United States
Investigational Site Number 840104
Colorado Springs, Colorado, United States
Investigational Site Number 840128
Colorado Springs, Colorado, United States
Investigational Site Number 840098
Denver, Colorado, United States
Investigational Site Number 840518
Brandon, Florida, United States
Investigational Site Number 840049
Daytona Beach, Florida, United States
Investigational Site Number 840008
Jacksonville, Florida, United States
Investigational Site Number 840520
Miami, Florida, United States
Investigational Site Number 840025
New Port Richey, Florida, United States
Investigational Site Number 840011
Ocoee, Florida, United States
Investigational Site Number 840141
Palm Harbor, Florida, United States
Investigational Site Number 840513
Pembroke Pines, Florida, United States
Investigational Site Number 840528
Columbus, Georgia, United States
Investigational Site Number 840050
Idaho Falls, Idaho, United States
Investigational Site Number 840107
Nampa, Idaho, United States
Investigational Site Number 840199
Chicago, Illinois, United States
Investigational Site Number 840021
McHenry, Illinois, United States
Investigational Site Number 840020
Springfield, Illinois, United States
Investigational Site Number 840045
Avon, Indiana, United States
Investigational Site Number 840077
Avon, Indiana, United States
Investigational Site Number 840088
Avon, Indiana, United States
Investigational Site Number 840089
Avon, Indiana, United States
Investigational Site Number 840091
Avon, Indiana, United States
Investigational Site Number 840130
Evansville, Indiana, United States
Investigational Site Number 840142
Lafayette, Indiana, United States
Investigational Site Number 840041
Paducah, Kentucky, United States
Investigational Site Number 840034
Baltimore, Maryland, United States
Investigational Site Number 840150
Baltimore, Maryland, United States
Investigational Site Number 840031
Rockville, Maryland, United States
Investigational Site Number 840063
Ann Arbor, Michigan, United States
Investigational Site Number 840064
Dearborn, Michigan, United States
Investigational Site Number 840094
Flint, Michigan, United States
Investigational Site Number 840023
Southfield, Michigan, United States
Investigational Site Number 840066
Eagan, Minnesota, United States
Investigational Site Number 840081
Minneapolis, Minnesota, United States
Investigational Site Number 840158
Biloxi, Mississippi, United States
Investigational Site Number 840526
Chesterfield, Missouri, United States
Investigational Site Number 840502
Butte, Montana, United States
Investigational Site Number 840084
Fremont, Nebraska, United States
Investigational Site Number 840085
Omaha, Nebraska, United States
Investigational Site Number 840162
Las Vegas, Nevada, United States
Investigational Site Number 840527
Las Vegas, Nevada, United States
Investigational Site Number 840056
Las Vegas, Nevada, United States
Investigational Site Number 840135
Summit, New Jersey, United States
Investigational Site Number 840145
Toms River, New Jersey, United States
Investigational Site Number 840087
Toms River, New Jersey, United States
Investigational Site Number 840140
Calabash, North Carolina, United States
Investigational Site Number 840139
Hickory, North Carolina, United States
Investigational Site Number 840153
Hickory, North Carolina, United States
Investigational Site Number 840047
Wilmington, North Carolina, United States
Investigational Site Number 840024
Winston-Salem, North Carolina, United States
Investigational Site Number 840065
Fargo, North Dakota, United States
Investigational Site Number 840007
Cincinnati, Ohio, United States
Investigational Site Number 840097
Columbus, Ohio, United States
Investigational Site Number 840113
Dayton, Ohio, United States
Investigational Site Number 840108
Maumee, Ohio, United States
Investigational Site Number 840504
Eugene, Oregon, United States
Investigational Site Number 840080
Medford, Oregon, United States
Investigational Site Number 840148
Tipton, Pennsylvania, United States
Investigational Site Number 840005
Uniontown, Pennsylvania, United States
Investigational Site Number 840076
Greer, South Carolina, United States
Investigational Site Number 840503
Simpsonville, South Carolina, United States
Investigational Site Number 840048
Rapid City, South Dakota, United States
Investigational Site Number 840028
Bristol, Tennessee, United States
Investigational Site Number 840038
Chattanooga, Tennessee, United States
Investigational Site Number 840042
Knoxville, Tennessee, United States
Investigational Site Number 840160
Memphis, Tennessee, United States
Investigational Site Number 840033
Memphis, Tennessee, United States
Investigational Site Number 840022
Austin, Texas, United States
Investigational Site Number 840078
Austin, Texas, United States
Investigational Site Number 840519
Corpus Christi, Texas, United States
Investigational Site Number 840001
Dallas, Texas, United States
Investigational Site Number 840159
Dallas, Texas, United States
Investigational Site Number 840115
Dallas, Texas, United States
Investigational Site Number 840079
Houston, Texas, United States
Investigational Site Number 840514
Houston, Texas, United States
Investigational Site Number 840525
San Antonio, Texas, United States
Investigational Site Number 840161
San Antonio, Texas, United States
Investigational Site Number 840009
Draper, Utah, United States
Investigational Site Number 840037
Orem, Utah, United States
Investigational Site Number 840510
Salt Lake City, Utah, United States
Investigational Site Number 840032
Chesapeake, Virginia, United States
Investigational Site Number 840040
Norfolk, Virginia, United States
Investigational Site Number 840095
Richmond, Virginia, United States
Investigational Site Number 840072
Williamsburg, Virginia, United States
Investigational Site Number 840134
Winchester, Virginia, United States
Investigational Site Number 840523
Olympia, Washington, United States
Investigational Site Number 840122
Walla Walla, Washington, United States
Investigational Site Number 840019
Milwaukee, Wisconsin, United States
Investigational Site Number 124024
Beamsville, , Canada
Investigational Site Number 124025
Burlington, , Canada
Investigational Site Number 124020
Calgary, , Canada
Investigational Site Number 124019
Chilliwack, , Canada
Investigational Site Number 124018
Coquitlam, , Canada
Investigational Site Number 124016
Edmonton, , Canada
Investigational Site Number 124014
Hamilton, , Canada
Investigational Site Number 124004
Mirabel, , Canada
Investigational Site Number 124026
Mississauga, , Canada
Investigational Site Number 124002
Red Deer, , Canada
Investigational Site Number 124013
Sherbrooke, , Canada
Investigational Site Number 124011
Toronto, , Canada
Investigational Site Number 124010
Victoria, , Canada
Investigational Site Number 124022
Winnipeg, , Canada
Investigational Site Number 152014
Osorno, , Chile
Investigational Site Number 152012
Rancagua, , Chile
Investigational Site Number 152005
Santiago, , Chile
Investigational Site Number 152004
Santiago, , Chile
Investigational Site Number 152003
Santiago, , Chile
Investigational Site Number 152001
Santiago, , Chile
Investigational Site Number 152013
Santiago, , Chile
Investigational Site Number 152002
Santiago, , Chile
Investigational Site Number 152007
Santiago, , Chile
Investigational Site Number 152010
Santiago, , Chile
Investigational Site Number 152006
Temuco, , Chile
Investigational Site Number 152009
Valdivia, , Chile
Investigational Site Number 246001
Helsinki, , Finland
Investigational Site Number 250001
La Rochelle, , France
Investigational Site Number 250004
Le Creusot, , France
Investigational Site Number 250005
Mantes-la-Jolie, , France
Investigational Site Number 250002
Nantes, , France
Investigational Site Number 250009
Strasbourg, , France
Investigational Site Number 250003
Vénissieux, , France
Investigational Site Number 276004
Künzing, , Germany
Investigational Site Number 276003
Neumünster, , Germany
Investigational Site Number 276008
Oberhausen, , Germany
Investigational Site Number 276009
Pirna, , Germany
Investigational Site Number 276007
Rehlingen-Siersburg, , Germany
Investigational Site Number 276005
Wangen, , Germany
Investigational Site Number 348006
Baja, , Hungary
Investigational Site Number 348005
Budapest, , Hungary
Investigational Site Number 348003
Budapest, , Hungary
Investigational Site Number 348010
Budapest, , Hungary
Investigational Site Number 348009
Budapest, , Hungary
Investigational Site Number 348002
Eger, , Hungary
Investigational Site Number 348001
Makó, , Hungary
Investigational Site Number 348008
Mosonmagyaróvár, , Hungary
Investigational Site Number 348004
Pápa, , Hungary
Investigational Site Number 348007
Sátorlaljaújhely, , Hungary
Investigational Site Number 484009
Acapulco, , Mexico
Investigational Site Number 484007
Guadalajara, , Mexico
Investigational Site Number 484008
Guadalajara, , Mexico
Investigational Site Number 484010
Guadalajara, , Mexico
Investigational Site Number 484006
Mexico City, , Mexico
Investigational Site Number 484001
Monterrey, , Mexico
Investigational Site Number 484003
Monterrey, , Mexico
Investigational Site Number 484004
Pachuca, , Mexico
Investigational Site Number 620007
Matosinhos Municipality, , Portugal
Investigational Site Number 620004
Porto, , Portugal
Investigational Site Number 642008
Bacau, , Romania
Investigational Site Number 642009
Brasov, , Romania
Investigational Site Number 642003
Bucharest, , Romania
Investigational Site Number 642001
Bucharest, , Romania
Investigational Site Number 642002
Bucharest, , Romania
Investigational Site Number 642014
Cluj-Napoca, , Romania
Investigational Site Number 642006
Deva, , Romania
Investigational Site Number 642011
Hunedoara, , Romania
Investigational Site Number 642015
Iași, , Romania
Investigational Site Number 642013
Oradea, , Romania
Investigational Site Number 642010
Ploieşti, , Romania
Investigational Site Number 642004
Reşiţa, , Romania
Investigational Site Number 642007
Târgu Mureş, , Romania
Investigational Site Number 642012
Timișoara, , Romania
Investigational Site Number 642005
Timișoara, , Romania
Investigational Site Number 643010
Moscow, , Russia
Investigational Site Number 643007
Moscow, , Russia
Investigational Site Number 643009
Saint Petersburg, , Russia
Investigational Site Number 643006
Saint Petersburg, , Russia
Investigational Site Number 643014
Saint Petersburg, , Russia
Investigational Site Number 643008
Saint Petersburg, , Russia
Investigational Site Number 643013
Saint Petersburg, , Russia
Investigational Site Number 643004
Saint Petersburg, , Russia
Investigational Site Number 643001
Saint Petersburg, , Russia
Investigational Site Number 643011
Samara, , Russia
Investigational Site Number 643002
Saratov, , Russia
Investigational Site Number 643016
Ufa, , Russia
Investigational Site Number 643005
Voronezh, , Russia
Investigational Site Number 710007
Benoni, , South Africa
Investigational Site Number 710006
Bloemfontein, , South Africa
Investigational Site Number 710014
Bloemfontein, , South Africa
Investigational Site Number 710002
Boksburg, , South Africa
Investigational Site Number 710003
Cape Town, , South Africa
Investigational Site Number 710010
Cape Town, , South Africa
Investigational Site Number 710008
eMkhomazi, , South Africa
Investigational Site Number 710001
Johannesburg, , South Africa
Investigational Site Number 710005
Pretoria, , South Africa
Investigational Site Number 710012
Somerset West, , South Africa
Investigational Site Number 724005
Barcelona, , Spain
Investigational Site Number 724003
Málaga, , Spain
Investigational Site Number 724006
Palma de Mallorca, , Spain
Investigational Site Number 724001
Sabadell, , Spain
Investigational Site Number 724002
Seville, , Spain
Investigational Site Number 724004
Valancia, , Spain
Countries
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References
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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.
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.
Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.
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.
Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.
Yki-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.
Other Identifiers
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2010-023770-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-6943
Identifier Type: OTHER
Identifier Source: secondary_id
EFC11629
Identifier Type: -
Identifier Source: org_study_id
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