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Clinical Trial Details

Trial ID: L3855
Source ID: NCT01499095
Associated Drug: Lantus (Insulin Glargine)
Title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Acronym: EDITION II
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01499095/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Lantus (Insulin glargine)|DRUG: HOE901-U300 (new formulation of insulin glargine)
Outcome Measures: Primary: Change in HbA1c From Baseline to Month 6 Endpoint, Only measurements performed before initiation of rescue therapy were considered in the analysis., 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 mmol/L (70 milligram per deciliter \[mg/dL\]). Only measurements performed before initiation of rescue therapy were considered in the analysis., 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., 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., 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., 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., 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., 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., 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., 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., 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)., 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. Only measurements performed before initiation of rescue therapy were considered in the analysis., Month 6 up to Month 9
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 811
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12
Completion Date: 2013-11
Results First Posted: 2015-04-23
Last Update Posted: 2022-03-23
Locations: Investigational Site Number 840517, Birmingham, Alabama, 35213, United States|Investigational Site Number 840149, Chandler, Arizona, 85224, United States|Investigational Site Number 840093, Glendale, Arizona, 85306, United States|Investigational Site Number 840069, Phoenix, Arizona, 85028, United States|Investigational Site Number 840110, Sun City, Arizona, 85351, United States|Investigational Site Number 840068, Tempe, Arizona, 85282, United States|Investigational Site Number 840015, Hot Springs, Arkansas, 71913, United States|Investigational Site Number 840014, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840114, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840018, Mountain Home, Arkansas, 72653, United States|Investigational Site Number 840027, Searcy, Arkansas, 72143, United States|Investigational Site Number 840074, Anaheim, California, 92801, United States|Investigational Site Number 840509, Bell Gardens, California, 90201, United States|Investigational Site Number 840060, Greenbrae, California, 94904, United States|Investigational Site Number 840057, La Jolla, California, 92037, United States|Investigational Site Number 840003, La Mesa, California, 91942, United States|Investigational Site Number 840026, Los Angeles, California, 90073, United States|Investigational Site Number 840090, Mission Hills, California, 91345, United States|Investigational Site Number 840099, Palm Springs, California, 92262, United States|Investigational Site Number 840004, San Diego, California, 92161, United States|Investigational Site Number 840124, Santa Barbara, California, 93110, United States|Investigational Site Number 840012, Tustin, California, 92780, United States|Investigational Site Number 840104, Colorado Springs, Colorado, 80906, United States|Investigational Site Number 840128, Colorado Springs, Colorado, 80909, United States|Investigational Site Number 840098, Denver, Colorado, 80206, United States|Investigational Site Number 840518, Brandon, Florida, 33511, United States|Investigational Site Number 840049, Daytona Beach, Florida, 32117, United States|Investigational Site Number 840008, Jacksonville, Florida, 32258, United States|Investigational Site Number 840520, Miami, Florida, 33015, United States|Investigational Site Number 840025, New Port Richey, Florida, 34652, United States|Investigational Site Number 840011, Ocoee, Florida, 34761, United States|Investigational Site Number 840141, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840513, Pembroke Pines, Florida, 33029, United States|Investigational Site Number 840528, Columbus, Georgia, 31901, United States|Investigational Site Number 840050, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840107, Nampa, Idaho, 83686, United States|Investigational Site Number 840199, Chicago, Illinois, 60612, United States|Investigational Site Number 840021, McHenry, Illinois, 60050, United States|Investigational Site Number 840020, Springfield, Illinois, 62704, United States|Investigational Site Number 840045, Avon, Indiana, 46123, United States|Investigational Site Number 840077, Avon, Indiana, 46123, United States|Investigational Site Number 840088, Avon, Indiana, 46123, United States|Investigational Site Number 840089, Avon, Indiana, 46123, United States|Investigational Site Number 840091, Avon, Indiana, 46123, United States|Investigational Site Number 840130, Evansville, Indiana, 47714, United States|Investigational Site Number 840142, Lafayette, Indiana, 47904, United States|Investigational Site Number 840041, Paducah, Kentucky, 42003, United States|Investigational Site Number 840034, Baltimore, Maryland, 21237, United States|Investigational Site Number 840150, Baltimore, Maryland, 21237, United States|Investigational Site Number 840031, Rockville, Maryland, 20852, United States|Investigational Site Number 840063, Ann Arbor, Michigan, 48106, United States|Investigational Site Number 840064, Dearborn, Michigan, 48124, United States|Investigational Site Number 840094, Flint, Michigan, 48504, United States|Investigational Site Number 840023, Southfield, Michigan, 48034, United States|Investigational Site Number 840066, Eagan, Minnesota, 55122, United States|Investigational Site Number 840081, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840158, Biloxi, Mississippi, 39531, United States|Investigational Site Number 840526, Chesterfield, Missouri, 63017, United States|Investigational Site Number 840502, Butte, Montana, 59701, United States|Investigational Site Number 840084, Fremont, Nebraska, 68025, United States|Investigational Site Number 840085, Omaha, Nebraska, 68130, United States|Investigational Site Number 840162, Las Vegas, Nevada, 89102, United States|Investigational Site Number 840527, Las Vegas, Nevada, 89117, United States|Investigational Site Number 840056, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840135, Summit, New Jersey, 07901, United States|Investigational Site Number 840145, Toms River, New Jersey, 08721, United States|Investigational Site Number 840087, Toms River, New Jersey, 08753, United States|Investigational Site Number 840140, Calabash, North Carolina, 28467, United States|Investigational Site Number 840139, Hickory, North Carolina, 28601, United States|Investigational Site Number 840153, Hickory, North Carolina, 28601, United States|Investigational Site Number 840047, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840024, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 840065, Fargo, North Dakota, 58103, United States|Investigational Site Number 840007, Cincinnati, Ohio, 45236, United States|Investigational Site Number 840097, Columbus, Ohio, 43213, United States|Investigational Site Number 840113, Dayton, Ohio, 45439, United States|Investigational Site Number 840108, Maumee, Ohio, 43537, United States|Investigational Site Number 840504, Eugene, Oregon, United States|Investigational Site Number 840080, Medford, Oregon, 97504, United States|Investigational Site Number 840148, Tipton, Pennsylvania, 16684, United States|Investigational Site Number 840005, Uniontown, Pennsylvania, 15401, United States|Investigational Site Number 840076, Greer, South Carolina, 29651, United States|Investigational Site Number 840503, Simpsonville, South Carolina, 29681, United States|Investigational Site Number 840048, Rapid City, South Dakota, 57701, United States|Investigational Site Number 840028, Bristol, Tennessee, 37620, United States|Investigational Site Number 840038, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840042, Knoxville, Tennessee, 37912, United States|Investigational Site Number 840160, Memphis, Tennessee, 38119, United States|Investigational Site Number 840033, Memphis, Tennessee, 38125, United States|Investigational Site Number 840022, Austin, Texas, 78731, United States|Investigational Site Number 840078, Austin, Texas, 78758, United States|Investigational Site Number 840519, Corpus Christi, Texas, 78404, United States|Investigational Site Number 840001, Dallas, Texas, 75230, United States|Investigational Site Number 840159, Dallas, Texas, 75231, United States|Investigational Site Number 840115, Dallas, Texas, 75246, United States|Investigational Site Number 840079, Houston, Texas, 77030, United States|Investigational Site Number 840514, Houston, Texas, 77074, United States|Investigational Site Number 840525, San Antonio, Texas, 78229, United States|Investigational Site Number 840161, San Antonio, Texas, 78258, United States|Investigational Site Number 840009, Draper, Utah, 84020, United States|Investigational Site Number 840037, Orem, Utah, 84058, United States|Investigational Site Number 840510, Salt Lake City, Utah, 84107, United States|Investigational Site Number 840032, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840040, Norfolk, Virginia, 23510, United States|Investigational Site Number 840095, Richmond, Virginia, 23235, United States|Investigational Site Number 840072, Williamsburg, Virginia, 23185, United States|Investigational Site Number 840134, Winchester, Virginia, 22601, United States|Investigational Site Number 840523, Olympia, Washington, 98502, United States|Investigational Site Number 840122, Walla Walla, Washington, 99362, United States|Investigational Site Number 840019, 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 124020, Calgary, T2N 4L7, Canada|Investigational Site Number 124019, Chilliwack, V2P 4M9, Canada|Investigational Site Number 124018, Coquitlam, V3K 3P4, Canada|Investigational Site Number 124016, Edmonton, T5C 0A3, Canada|Investigational Site Number 124014, Hamilton, L8N 3Z5, Canada|Investigational Site Number 124004, Mirabel, J7J 2K8, Canada|Investigational Site Number 124026, Mississauga, L5M 2V8, Canada|Investigational Site Number 124002, Red Deer, T4N 6V7, Canada|Investigational Site Number 124013, Sherbrooke, J1H 5N4, Canada|Investigational Site Number 124011, Toronto, M5C 2T2, Canada|Investigational Site Number 124010, Victoria, V8V 4A1, Canada|Investigational Site Number 124022, Winnipeg, R3E 3P4, Canada|Investigational Site Number 152014, Osorno, 5311092, Chile|Investigational Site Number 152012, Rancagua, 2841959, Chile|Investigational Site Number 152005, Santiago, 7500010, Chile|Investigational Site Number 152004, Santiago, 7500710, Chile|Investigational Site Number 152003, Santiago, 751-0009, Chile|Investigational Site Number 152001, Santiago, 7980378, Chile|Investigational Site Number 152013, Santiago, 7980378, Chile|Investigational Site Number 152002, Santiago, 80004005, Chile|Investigational Site Number 152007, Santiago, 8053095, Chile|Investigational Site Number 152010, Santiago, Chile|Investigational Site Number 152006, Temuco, 4813299, Chile|Investigational Site Number 152009, Valdivia, 56 63, Chile|Investigational Site Number 246001, Helsinki, 00290, Finland|Investigational Site Number 250001, La Rochelle Cedex, 17019, France|Investigational Site Number 250004, Le Creusot, 71200, France|Investigational Site Number 250005, Mantes La Jolie, 78200, France|Investigational Site Number 250002, Nantes, 44093, France|Investigational Site Number 250009, Strasbourg, 67000, France|Investigational Site Number 250003, Venissieux, 69200, France|Investigational Site Number 276004, Künzing, 94550, Germany|Investigational Site Number 276003, Neumünster, 24534, Germany|Investigational Site Number 276008, Oberhausen, 46045, Germany|Investigational Site Number 276009, Pirna, 01796, Germany|Investigational Site Number 276007, Rehlingen-Siersburg, 66780, Germany|Investigational Site Number 276005, Wangen, 88239, Germany|Investigational Site Number 348006, Baja, 6500, Hungary|Investigational Site Number 348005, Budapest, 1032, Hungary|Investigational Site Number 348003, Budapest, 1139, Hungary|Investigational Site Number 348010, Budapest, 1145, Hungary|Investigational Site Number 348009, Budapest, 1204, Hungary|Investigational Site Number 348002, Eger, 3300, Hungary|Investigational Site Number 348001, Makó, 6900, Hungary|Investigational Site Number 348008, Mosonmagyaróvár, 9200, Hungary|Investigational Site Number 348004, Pápa, 8500, Hungary|Investigational Site Number 348007, Sátorlaljaújhely, 3980, Hungary|Investigational Site Number 484009, Acapulco, 39670, Mexico|Investigational Site Number 484007, Guadalajara, 44210, Mexico|Investigational Site Number 484008, Guadalajara, 44656, Mexico|Investigational Site Number 484010, Guadalajara, Guadalajara, Mexico|Investigational Site Number 484006, Mexico City, 11550, Mexico|Investigational Site Number 484001, Monterrey, 64020, Mexico|Investigational Site Number 484003, Monterrey, 64240, Mexico|Investigational Site Number 484004, Pachuca, 42060, Mexico|Investigational Site Number 620007, Matosinhos, Portugal|Investigational Site Number 620004, Porto, 4200, Portugal|Investigational Site Number 642008, Bacau, 600164, Romania|Investigational Site Number 642009, Brasov, 500365, Romania|Investigational Site Number 642003, Bucuresti, 020475, Romania|Investigational Site Number 642001, Bucuresti, 20475, Romania|Investigational Site Number 642002, Bucuresti, 20475, Romania|Investigational Site Number 642014, Cluj Napoca, 400006, Romania|Investigational Site Number 642006, Deva, 330084, Romania|Investigational Site Number 642011, Hunedoara, 331057, Romania|Investigational Site Number 642015, Iasi, 700547, Romania|Investigational Site Number 642013, Oradea, 410169, Romania|Investigational Site Number 642010, Ploiesti, 100097, Romania|Investigational Site Number 642004, Resita, 320076, Romania|Investigational Site Number 642007, Targu Mures, 540142, Romania|Investigational Site Number 642012, Timisoara, 300133, Romania|Investigational Site Number 642005, Timisoara, 300456, Romania|Investigational Site Number 643010, Moscow, 123423, Russian Federation|Investigational Site Number 643007, Moscow, 129110, Russian Federation|Investigational Site Number 643011, Samara, 443095, Russian Federation|Investigational Site Number 643002, Saratov, 410030, Russian Federation|Investigational Site Number 643009, St-Petersburg, 194291, Russian Federation|Investigational Site Number 643006, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643014, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643013, St-Petersburg, 195112, Russian Federation|Investigational Site Number 643004, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643001, St-Petersburg, 198013, Russian Federation|Investigational Site Number 643008, St. Petersburg, 194358, Russian Federation|Investigational Site Number 643016, Ufa, 450000, Russian Federation|Investigational Site Number 643005, Voronezh, 394018, Russian Federation|Investigational Site Number 710007, Benoni, 1501, South Africa|Investigational Site Number 710006, Bloemfontein, 9301, South Africa|Investigational Site Number 710014, Bloemfontein, 9301, South Africa|Investigational Site Number 710002, Boksburg, 1459, South Africa|Investigational Site Number 710003, Cape Town, 7130, South Africa|Investigational Site Number 710010, Cape Town, 7500, South Africa|Investigational Site Number 710001, Johannesburg, 2013, South Africa|Investigational Site Number 710005, Pretoria, 0001, South Africa|Investigational Site Number 710012, Somerset West, 7130, South Africa|Investigational Site Number 710008, Umkomaas, 4170, South Africa|Investigational Site Number 724005, Barcelona, 08022, Spain|Investigational Site Number 724003, Malaga, 29010, Spain|Investigational Site Number 724006, Palma De Mallorca, 07198, Spain|Investigational Site Number 724001, Sabadell, 08208, Spain|Investigational Site Number 724002, Sevilla, 41010, Spain|Investigational Site Number 724004, Valancia, 46014, Spain
URL: https://clinicaltrials.gov/show/NCT01499095

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress