Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
NCT ID: NCT01499082
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
807 participants
INTERVENTIONAL
2011-12-31
2013-09-30
Brief Summary
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* 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
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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 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
Lantus (insulin glargine)
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).
Interventions
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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 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)
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).
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 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
* 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
* 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 840156
Chandler, Arizona, United States
Investigational Site Number 840102
Glendale, Arizona, United States
Investigational Site Number 840071
Phoenix, Arizona, United States
Investigational Site Number 840121
Sun City, Arizona, United States
Investigational Site Number 840070
Tempe, Arizona, United States
Investigational Site Number 840016
Hot Springs, Arkansas, United States
Investigational Site Number 840015
Little Rock, Arkansas, United States
Investigational Site Number 840124
Little Rock, Arkansas, United States
Investigational Site Number 840032
Searcy, Arkansas, United States
Investigational Site Number 840076
Anaheim, California, United States
Investigational Site Number 840133
Encino, California, United States
Investigational Site Number 840062
Greenbrae, California, United States
Investigational Site Number 840057
Huntington Beach, California, United States
Investigational Site Number 840059
La Jolla, California, United States
Investigational Site Number 840004
La Mesa, California, United States
Investigational Site Number 840099
Mission Hills, California, United States
Investigational Site Number 840107
Palm Springs, California, United States
Investigational Site Number 840005
San Diego, California, United States
Investigational Site Number 840013
Tustin, California, United States
Investigational Site Number 840002
Walnut Creek, California, United States
Investigational Site Number 840114
Colorado Springs, Colorado, United States
Investigational Site Number 840136
Colorado Springs, Colorado, United States
Investigational Site Number 840092
Longmont, Colorado, United States
Investigational Site Number 840049
Daytona Beach, Florida, United States
Investigational Site Number 840050
Hollywood, Florida, United States
Investigational Site Number 840086
Jacksonville, Florida, United States
Investigational Site Number 840011
Jacksonville, Florida, United States
Investigational Site Number 840009
Jacksonville, Florida, United States
Investigational Site Number 840023
New Port Richey, Florida, United States
Investigational Site Number 840012
Ocoee, Florida, United States
Investigational Site Number 840148
Palm Harbor, Florida, United States
Investigational Site Number 840055
Lawrenceville, Georgia, United States
Investigational Site Number 840052
Idaho Falls, Idaho, United States
Investigational Site Number 840117
Nampa, Idaho, United States
Investigational Site Number 840020
McHenry, Illinois, United States
Investigational Site Number 840019
Springfield, Illinois, United States
Investigational Site Number 840078
Avon, Indiana, United States
Investigational Site Number 840089
Avon, Indiana, United States
Investigational Site Number 840097
Avon, Indiana, United States
Investigational Site Number 840098
Avon, Indiana, United States
Investigational Site Number 840100
Avon, Indiana, United States
Investigational Site Number 840127
Vincennes, Indiana, United States
Investigational Site Number 840116
Des Moines, Iowa, United States
Investigational Site Number 840003
Wichita, Kansas, United States
Investigational Site Number 840080
Lexington, Kentucky, United States
Investigational Site Number 840042
Paducah, Kentucky, United States
Investigational Site Number 840036
Baltimore, Maryland, United States
Investigational Site Number 840155
Baltimore, Maryland, United States
Investigational Site Number 840034
Rockville, Maryland, United States
Investigational Site Number 840065
Ann Arbor, Michigan, United States
Investigational Site Number 840066
Dearborn, Michigan, United States
Investigational Site Number 840103
Flint, Michigan, United States
Investigational Site Number 840126
Kalamazoo, Michigan, United States
Investigational Site Number 840022
Southfield, Michigan, United States
Investigational Site Number 840143
Chaska, Minnesota, United States
Investigational Site Number 840068
Eagan, Minnesota, United States
Investigational Site Number 840085
Minneapolis, Minnesota, United States
Investigational Site Number 840053
Kalispell, Montana, United States
Investigational Site Number 840090
Fremont, Nebraska, United States
Investigational Site Number 840091
Omaha, Nebraska, United States
Investigational Site Number 840058
Las Vegas, Nevada, United States
Investigational Site Number 840043
Brick, New Jersey, United States
Investigational Site Number 840152
Toms River, New Jersey, United States
Investigational Site Number 840146
Asheville, North Carolina, United States
Investigational Site Number 840145
Hickory, North Carolina, United States
Investigational Site Number 840045
Wilmington, North Carolina, United States
Investigational Site Number 840067
Fargo, North Dakota, United States
Investigational Site Number 840008
Cincinnati, Ohio, United States
Investigational Site Number 840106
Columbus, Ohio, United States
Investigational Site Number 840123
Dayton, Ohio, United States
Investigational Site Number 840119
Maumee, Ohio, United States
Investigational Site Number 840122
Mentor, Ohio, United States
Investigational Site Number 840083
Medford, Oregon, United States
Investigational Site Number 840084
Portland, Oregon, United States
Investigational Site Number 840007
Uniontown, Pennsylvania, United States
Investigational Site Number 840079
Greer, South Carolina, United States
Investigational Site Number 840048
Rapid City, South Dakota, United States
Investigational Site Number 840039
Chattanooga, Tennessee, United States
Investigational Site Number 840159
Knoxville, Tennessee, United States
Investigational Site Number 840021
Austin, Texas, United States
Investigational Site Number 840129
Austin, Texas, United States
Investigational Site Number 840081
Austin, Texas, United States
Investigational Site Number 840001
Dallas, Texas, United States
Investigational Site Number 840047
Dallas, Texas, United States
Investigational Site Number 840082
Houston, Texas, United States
Investigational Site Number 840120
Hurst, Texas, United States
Investigational Site Number 840010
Draper, Utah, United States
Investigational Site Number 840060
Ogden, Utah, United States
Investigational Site Number 840035
Chesapeake, Virginia, United States
Investigational Site Number 840074
Norfolk, Virginia, United States
Investigational Site Number 840112
Norfolk, Virginia, United States
Investigational Site Number 840041
Norfolk, Virginia, United States
Investigational Site Number 840104
Richmond, Virginia, United States
Investigational Site Number 840075
Williamsburg, Virginia, United States
Investigational Site Number 840018
Milwaukee, Wisconsin, United States
Investigational Site Number 124024
Beamsville, , Canada
Investigational Site Number 124025
Burlington, , Canada
Investigational Site Number 124023
Calgary, , Canada
Investigational Site Number 124020
Calgary, , Canada
Investigational Site Number 124019
Chatham, , Canada
Investigational Site Number 124018
Coquitlam, , Canada
Investigational Site Number 124021
Hamilton, , Canada
Investigational Site Number 124014
Hamilton, , Canada
Investigational Site Number 124006
Laval, , Canada
Investigational Site Number 124009
London, , Canada
Investigational Site Number 124008
Mississauga, , Canada
Investigational Site Number 124015
Montreal, , Canada
Investigational Site Number 124004
Montreal, , Canada
Investigational Site Number 124005
Oshawa, , Canada
Investigational Site Number 124026
Québec, , Canada
Investigational Site Number 124002
Red Deer, , Canada
Investigational Site Number 124017
Saint-Laurent, , Canada
Investigational Site Number 124007
Thornhill, , Canada
Investigational Site Number 124001
Toronto, , Canada
Investigational Site Number 124011
Toronto, , Canada
Investigational Site Number 124010
Victoria, , Canada
Investigational Site Number 124022
Winnipeg, , Canada
Investigational Site Number 203006
Beroun, , Czechia
Investigational Site Number 203001
Břeclav, , Czechia
Investigational Site Number 203002
Hodonín, , Czechia
Investigational Site Number 203009
Holešov, , Czechia
Investigational Site Number 203003
Hradec Králové, , Czechia
Investigational Site Number 203007
Hranice, , Czechia
Investigational Site Number 203004
Krnov, , Czechia
Investigational Site Number 203010
Olomouc, , Czechia
Investigational Site Number 203008
Prague, , Czechia
Investigational Site Number 203005
Prostějov, , Czechia
Investigational Site Number 233002
Pärnu, , Estonia
Investigational Site Number 233004
Tallinn, , Estonia
Investigational Site Number 233006
Tallinn, , Estonia
Investigational Site Number 233003
Tallinn, , Estonia
Investigational Site Number 233001
Tallinn, , Estonia
Investigational Site Number 233005
Tartu, , Estonia
Investigational Site Number 246001
Helsinki, , Finland
Investigational Site Number 246005
Kuopio, , Finland
Investigational Site Number 246002
Oulu, , Finland
Investigational Site Number 250004
La Rochelle, , France
Investigational Site Number 250002
Strasbourg, , France
Investigational Site Number 276006
Heidelberg, , Germany
Investigational Site Number 276002
Riesa, , Germany
Investigational Site Number 276003
Schwabenheim, , Germany
Investigational Site Number 348010
Baja, , Hungary
Investigational Site Number 348004
Balatonfüred, , Hungary
Investigational Site Number 348015
Budapest, , Hungary
Investigational Site Number 348013
Budapest, , Hungary
Investigational Site Number 348017
Budapest, , Hungary
Investigational Site Number 348009
Budapest, , Hungary
Investigational Site Number 348002
Budapest, , Hungary
Investigational Site Number 348005
Debrecen, , Hungary
Investigational Site Number 348008
Eger, , Hungary
Investigational Site Number 348018
Gyula, , Hungary
Investigational Site Number 348014
Makó, , Hungary
Investigational Site Number 348012
Mosonmagyaróvár, , Hungary
Investigational Site Number 348007
Nyiregyháza, , Hungary
Investigational Site Number 348011
Sátorlaljaújhely, , Hungary
Investigational Site Number 348003
Szeged, , Hungary
Investigational Site Number 348006
Szombathely, , Hungary
Investigational Site Number 348001
Zalaegerszeg, , Hungary
Investigational Site Number 428006
Jēkabpils, , Latvia
Investigational Site Number 428005
Ogre, , Latvia
Investigational Site Number 428002
Riga, , Latvia
Investigational Site Number 428001
Riga, , Latvia
Investigational Site Number 428004
Riga, , Latvia
Investigational Site Number 428003
Sigulda, , Latvia
Investigational Site Number 484007
Chihuahua City, , Mexico
Investigational Site Number 484001
Cuernavaca, , Mexico
Investigational Site Number 484006
Guadalajara, , Mexico
Investigational Site Number 484003
Monterrey, , Mexico
Investigational Site Number 484004
Pachuca, , Mexico
Investigational Site Number 528009
Almelo, , Netherlands
Investigational Site Number 528004
Eindhoven, , Netherlands
Investigational Site Number 528007
Groningen, , Netherlands
Investigational Site Number 528005
Hoogeveen, , Netherlands
Investigational Site Number 528001
Hoorn, , Netherlands
Investigational Site Number 528008
Leeuwarden, , Netherlands
Investigational Site Number 528006
Utrecht, , Netherlands
Investigational Site Number 528002
Venlo, , Netherlands
Investigational Site Number 642001
Bacau, , Romania
Investigational Site Number 642005
Bucharest, , Romania
Investigational Site Number 642006
Bucharest, , Romania
Investigational Site Number 642002
Cluj-Napoca, , Romania
Investigational Site Number 642004
Iași, , Romania
Investigational Site Number 642008
Iași, , Romania
Investigational Site Number 642003
Oradea, , Romania
Investigational Site Number 642009
Târgu Mureş, , Romania
Investigational Site Number 642007
Timișoara, , Romania
Investigational Site Number 710005
Alberton, , South Africa
Investigational Site Number 710003
Johannesburg, , South Africa
Investigational Site Number 710006
Lenasia, , South Africa
Investigational Site Number 710002
Observatory, , South Africa
Investigational Site Number 710001
Paarl, , South Africa
Investigational Site Number 710008
Pretoria, , South Africa
Investigational Site Number 710004
Somerset West, , South Africa
Countries
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References
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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.
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.
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.
Other Identifiers
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2010-023769-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC11628
Identifier Type: -
Identifier Source: org_study_id
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