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Clinical Trial Details

Trial ID: L5928
Source ID: NCT01499082
Associated Drug: Hoe901-U300 (New Formulation Of Insulin Glargine)
Title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Acronym: EDITION I
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01499082/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: HOE901-U300 (new formulation of insulin glargine)|DRUG: Lantus (insulin glargine)
Outcome Measures: Primary: Change in HbA1c From Baseline to Month 6 Endpoint, Baseline, Month 6 | Secondary: Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint, Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (\<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\])., Week 9 Up to Month 6|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint, Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit., Baseline, Month 6|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint, Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit., Baseline, Month 6|Percentage of Participants With HbA1c <7% at Month 6 Endpoint, Month 6|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint, Baseline, Month 6|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint, 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., Baseline, Month 6|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint, 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., Baseline, Month 6|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12, Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L)., Up to Month 12 | Other: Change in HbA1c From Month 6 to Month 9, Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months., Month 6 Up to Month 9
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 807
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date: 2013-09
Results First Posted: 2015-04-23
Last Update Posted: 2022-03-25
Locations: Investigational Site Number 840156, Chandler, Arizona, 85224, United States|Investigational Site Number 840102, Glendale, Arizona, 85306, United States|Investigational Site Number 840071, Phoenix, Arizona, 85028, United States|Investigational Site Number 840121, Sun City, Arizona, 85351, United States|Investigational Site Number 840070, Tempe, Arizona, 85282, United States|Investigational Site Number 840016, Hot Springs, Arkansas, 71913, United States|Investigational Site Number 840015, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840124, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840032, Searcy, Arkansas, 72143, United States|Investigational Site Number 840076, Anaheim, California, 92801, United States|Investigational Site Number 840133, Encino, California, 91436, United States|Investigational Site Number 840062, Greenbrae, California, 94904, United States|Investigational Site Number 840057, Huntington Beach, California, 92648, United States|Investigational Site Number 840059, La Jolla, California, 92037, United States|Investigational Site Number 840004, La Mesa, California, 91942, United States|Investigational Site Number 840099, Mission Hills, California, 91345, United States|Investigational Site Number 840107, Palm Springs, California, 92262, United States|Investigational Site Number 840005, San Diego, California, 92161, United States|Investigational Site Number 840013, Tustin, California, 92780, United States|Investigational Site Number 840002, Walnut Creek, California, 94598, United States|Investigational Site Number 840114, Colorado Springs, Colorado, 80906, United States|Investigational Site Number 840136, Colorado Springs, Colorado, 80910, United States|Investigational Site Number 840092, Longmont, Colorado, 80501, United States|Investigational Site Number 840049, Daytona Beach, Florida, 32117, United States|Investigational Site Number 840050, Hollywood, Florida, 33021, United States|Investigational Site Number 840086, Jacksonville, Florida, 32204, United States|Investigational Site Number 840011, Jacksonville, Florida, 32216, United States|Investigational Site Number 840009, Jacksonville, Florida, 32258, United States|Investigational Site Number 840023, New Port Richey, Florida, 34652, United States|Investigational Site Number 840012, Ocoee, Florida, 34761, United States|Investigational Site Number 840148, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840055, Lawrenceville, Georgia, 30045, United States|Investigational Site Number 840052, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840117, Nampa, Idaho, 83686, United States|Investigational Site Number 840020, McHenry, Illinois, 60050, United States|Investigational Site Number 840019, Springfield, Illinois, 62704, United States|Investigational Site Number 840078, Avon, Indiana, 46123, United States|Investigational Site Number 840089, Avon, Indiana, 46123, United States|Investigational Site Number 840097, Avon, Indiana, 46123, United States|Investigational Site Number 840098, Avon, Indiana, 46123, United States|Investigational Site Number 840100, Avon, Indiana, 46123, United States|Investigational Site Number 840127, Vincennes, Indiana, 47591, United States|Investigational Site Number 840116, Des Moines, Iowa, 50314, United States|Investigational Site Number 840003, Wichita, Kansas, 67211, United States|Investigational Site Number 840080, Lexington, Kentucky, 40504, United States|Investigational Site Number 840042, Paducah, Kentucky, 42003, United States|Investigational Site Number 840036, Baltimore, Maryland, 21237, United States|Investigational Site Number 840155, Baltimore, Maryland, 21237, United States|Investigational Site Number 840034, Rockville, Maryland, 20852, United States|Investigational Site Number 840065, Ann Arbor, Michigan, 48106, United States|Investigational Site Number 840066, Dearborn, Michigan, 48124, United States|Investigational Site Number 840103, Flint, Michigan, 48504, United States|Investigational Site Number 840126, Kalamazoo, Michigan, 49048, United States|Investigational Site Number 840022, Southfield, Michigan, 48034, United States|Investigational Site Number 840143, Chaska, Minnesota, 55318, United States|Investigational Site Number 840068, Eagan, Minnesota, 55122, United States|Investigational Site Number 840085, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840053, Kalispell, Montana, 59901, United States|Investigational Site Number 840090, Fremont, Nebraska, 68025, United States|Investigational Site Number 840091, Omaha, Nebraska, 68130, United States|Investigational Site Number 840058, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840043, Brick, New Jersey, 08274, United States|Investigational Site Number 840152, Toms River, New Jersey, 08721, United States|Investigational Site Number 840146, Asheville, North Carolina, 28801, United States|Investigational Site Number 840145, Hickory, North Carolina, 28601, United States|Investigational Site Number 840045, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840067, Fargo, North Dakota, 58103, United States|Investigational Site Number 840008, Cincinnati, Ohio, 45236, United States|Investigational Site Number 840106, Columbus, Ohio, 43213, United States|Investigational Site Number 840123, Dayton, Ohio, 45439, United States|Investigational Site Number 840119, Maumee, Ohio, 43537, United States|Investigational Site Number 840122, Mentor, Ohio, 44060, United States|Investigational Site Number 840083, Medford, Oregon, 97504, United States|Investigational Site Number 840084, Portland, Oregon, 97239-3098, United States|Investigational Site Number 840007, Uniontown, Pennsylvania, 15401, United States|Investigational Site Number 840079, Greer, South Carolina, 29651, United States|Investigational Site Number 840048, Rapid City, South Dakota, 57701, United States|Investigational Site Number 840039, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840159, Knoxville, Tennessee, 37912, United States|Investigational Site Number 840021, Austin, Texas, 78731, United States|Investigational Site Number 840129, Austin, Texas, 78731, United States|Investigational Site Number 840081, Austin, Texas, 78758, United States|Investigational Site Number 840001, Dallas, Texas, 75230, United States|Investigational Site Number 840047, Dallas, Texas, 75246, United States|Investigational Site Number 840082, Houston, Texas, 77096, United States|Investigational Site Number 840120, Hurst, Texas, 76054, United States|Investigational Site Number 840010, Draper, Utah, 84020, United States|Investigational Site Number 840060, Ogden, Utah, 84403, United States|Investigational Site Number 840035, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840074, Norfolk, Virginia, 23502, United States|Investigational Site Number 840112, Norfolk, Virginia, 23507, United States|Investigational Site Number 840041, Norfolk, Virginia, 23510, United States|Investigational Site Number 840104, Richmond, Virginia, 23235, United States|Investigational Site Number 840075, Williamsburg, Virginia, 23185, United States|Investigational Site Number 840018, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 124024, Beamsville, L0R 1B0, Canada|Investigational Site Number 124025, Burlington, L7M 4Y1, Canada|Investigational Site Number 124023, Calgary, T2H 2G4, Canada|Investigational Site Number 124020, Calgary, T2N 4L7, Canada|Investigational Site Number 124019, Chatham, N7L 1C1, Canada|Investigational Site Number 124018, Coquitlam, V3K 3P4, Canada|Investigational Site Number 124021, Hamilton, L8L 5G8, Canada|Investigational Site Number 124014, Hamilton, L8N 3Z5, Canada|Investigational Site Number 124006, Laval, H7T 2P5, Canada|Investigational Site Number 124009, London, N6A 4V2, Canada|Investigational Site Number 124008, Mississauga, L5M 2V8, Canada|Investigational Site Number 124015, Montreal, H2W 1R7, Canada|Investigational Site Number 124004, Montreal, H2W 1T8, Canada|Investigational Site Number 124005, Oshawa, L1H 7K4, Canada|Investigational Site Number 124026, Quebec, G1V 4G5, Canada|Investigational Site Number 124002, Red Deer, T4N 6V7, Canada|Investigational Site Number 124007, Thornhill, L4J 8L7, Canada|Investigational Site Number 124001, Toronto, M4G 3E8, Canada|Investigational Site Number 124011, Toronto, M5C 2T2, Canada|Investigational Site Number 124010, Victoria, V8V 4A1, Canada|Investigational Site Number 124017, Ville St-Laurent, H4T 1Z9, Canada|Investigational Site Number 124022, Winnipeg, R3E 3P4, Canada|Investigational Site Number 203006, Beroun, 26601, Czechia|Investigational Site Number 203001, Breclav, 690 02, Czechia|Investigational Site Number 203002, Hodonin, 69501, Czechia|Investigational Site Number 203009, Holesov, 76901, Czechia|Investigational Site Number 203003, Hradec Kralove, 50005, Czechia|Investigational Site Number 203007, Hranice, 75301, Czechia|Investigational Site Number 203004, Krnov, 79401, Czechia|Investigational Site Number 203010, Olomouc, 77900, Czechia|Investigational Site Number 203008, Praha 2, 12808, Czechia|Investigational Site Number 203005, Prostejov, 79601, Czechia|Investigational Site Number 233002, Pärnu, 80018, Estonia|Investigational Site Number 233004, Tallinn, 11313, Estonia|Investigational Site Number 233006, Tallinn, 11913, Estonia|Investigational Site Number 233003, Tallinn, 13415, Estonia|Investigational Site Number 233001, Tallinn, 13419, Estonia|Investigational Site Number 233005, Tartu, 50410, Estonia|Investigational Site Number 246001, Helsinki, 00260, Finland|Investigational Site Number 246005, Kuopio, 70210, Finland|Investigational Site Number 246002, Oulu, 90100, Finland|Investigational Site Number 250004, La Rochelle Cedex, 17019, France|Investigational Site Number 250002, Strasbourg, 67091, France|Investigational Site Number 276006, Heidelberg, 69115, Germany|Investigational Site Number 276002, Riesa, 01587, Germany|Investigational Site Number 276003, Schwabenheim, 55270, Germany|Investigational Site Number 348010, Baja, 6500, Hungary|Investigational Site Number 348004, Balatonfüred, 8230, Hungary|Investigational Site Number 348015, Budapest, 1083, Hungary|Investigational Site Number 348013, Budapest, 1088, Hungary|Investigational Site Number 348017, Budapest, 1134, Hungary|Investigational Site Number 348009, Budapest, 1139, Hungary|Investigational Site Number 348002, Budapest, Hungary|Investigational Site Number 348005, Debrecen, 4043, Hungary|Investigational Site Number 348008, Eger, 3300, Hungary|Investigational Site Number 348018, Gyula, 5700, Hungary|Investigational Site Number 348014, Makó, 6900, Hungary|Investigational Site Number 348012, Mosonmagyaróvár, 9200, Hungary|Investigational Site Number 348007, Nyiregyháza, 4400, Hungary|Investigational Site Number 348003, Szeged, 6722, Hungary|Investigational Site Number 348006, Szombathely, 9700, Hungary|Investigational Site Number 348011, Sátorlaljaújhely, 3980, Hungary|Investigational Site Number 348001, Zalaegerszeg, 8900, Hungary|Investigational Site Number 428006, Jekabpils, LV-5201, Latvia|Investigational Site Number 428005, Ogre, LV-5001, Latvia|Investigational Site Number 428002, Riga, LV-1002, Latvia|Investigational Site Number 428001, Riga, LV-1038, Latvia|Investigational Site Number 428004, Riga, LV-1050, Latvia|Investigational Site Number 428003, Sigulda, LV-2150, Latvia|Investigational Site Number 484007, Chihuahua, 31000, Mexico|Investigational Site Number 484001, Cuernavaca, 62250, Mexico|Investigational Site Number 484006, Guadalajara, 44670, Mexico|Investigational Site Number 484003, Monterrey, 64460, Mexico|Investigational Site Number 484004, Pachuca, 42060, Mexico|Investigational Site Number 528009, Almelo, 7609 PP, Netherlands|Investigational Site Number 528004, Eindhoven, 5631 BM, Netherlands|Investigational Site Number 528007, Groningen, 9728 NT, Netherlands|Investigational Site Number 528005, Hoogeveen, 7909 AA, Netherlands|Investigational Site Number 528001, Hoorn, 1064NP, Netherlands|Investigational Site Number 528008, Leeuwarden, 8934 AD, Netherlands|Investigational Site Number 528006, Utrecht, 3563 AZ, Netherlands|Investigational Site Number 528002, Venlo, 5912 BL, Netherlands|Investigational Site Number 642001, Bacau, 600114, Romania|Investigational Site Number 642005, Bucuresti, 020475, Romania|Investigational Site Number 642006, Bucuresti, 700164, Romania|Investigational Site Number 642002, Cluj Napoca, 400006, Romania|Investigational Site Number 642004, Iasi, 700547, Romania|Investigational Site Number 642008, Iasi, 700613, Romania|Investigational Site Number 642003, Oradea, 410169, Romania|Investigational Site Number 642009, Targu Mures, 540142, Romania|Investigational Site Number 642007, Timisoara, 300133, Romania|Investigational Site Number 710005, Alberton, 1450, South Africa|Investigational Site Number 710003, Johannesburg, 2198, South Africa|Investigational Site Number 710006, Lenasia, 1820, South Africa|Investigational Site Number 710002, Observatory, 7925, South Africa|Investigational Site Number 710001, Paarl, 7500, South Africa|Investigational Site Number 710008, Pretoria, 0167, South Africa|Investigational Site Number 710004, Somerset West, 7130, South Africa
URL: https://clinicaltrials.gov/show/NCT01499082

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress