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Clinical Trial Details

Trial ID: L3114
Source ID: NCT01683266
Associated Drug: Hoe901-U300 (Insulin Glargine New Formulation)
Title: Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Acronym: EDITION IV
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01683266/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: HOE901-U300 (Insulin glargine new formulation)|DRUG: Lantus (Insulin glargine)
Outcome Measures: Primary: Change In HbA1c From Baseline to Month 6 Endpoint, Baseline, Month 6 | Secondary: Percentage of Participants With HbA1c <7% at Month 6 Endpoint, Month 6|Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint, Month 6|Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline 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 Pre-injection 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|Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint, Baseline, Month 6|Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6, Month 6|Percentage of Participants With FPG <7.2 mmol/L (130 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 Average Total Insulin Dose From Baseline to Month 6 Endpoint, Baseline, Month 6|Change in Total 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 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
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 549
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-09
Completion Date: 2014-03
Results First Posted: 2015-04-23
Last Update Posted: 2015-06-24
Locations: Investigational Site Number 840156, Chandler, Arizona, 85224, United States|Investigational Site Number 840177, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840430, Bell Gardens, California, 90201, United States|Investigational Site Number 840131, Escondido, California, 92025, United States|Investigational Site Number 840140, Fresno, California, 93720, United States|Investigational Site Number 840107, Greenbrae, California, 94904, United States|Investigational Site Number 840149, Huntington Beach, California, 92648, United States|Investigational Site Number 840120, La Jolla, California, 92037, United States|Investigational Site Number 840123, La Mesa, California, 91942, United States|Investigational Site Number 840159, La Mesa, California, 91942, United States|Investigational Site Number 840114, Long Beach, California, 90806, United States|Investigational Site Number 840189, Mission Hills, California, 91345, United States|Investigational Site Number 840105, Temecula, California, 92591, United States|Investigational Site Number 840155, Tustin, California, 92780, United States|Investigational Site Number 840115, Walnut Creek, California, 94598, United States|Investigational Site Number 840160, Denver, Colorado, 80239, United States|Investigational Site Number 840188, Denver, Colorado, 80262, United States|Investigational Site Number 840196, New Haven, Connecticut, 06520, United States|Investigational Site Number 840113, Bradenton, Florida, 34208, United States|Investigational Site Number 840102, Hialeah, Florida, 33012, United States|Investigational Site Number 840134, Hollywood, Florida, 33021, United States|Investigational Site Number 840185, Jacksonville, Florida, 32216, United States|Investigational Site Number 840116, Jacksonville, Florida, 32258, United States|Investigational Site Number 840126, Miami, Florida, 33144, United States|Investigational Site Number 840179, Miami, Florida, 33176, United States|Investigational Site Number 840117, New Port Richey, Florida, 34652, United States|Investigational Site Number 840174, Orlando, Florida, 32806, United States|Investigational Site Number 840110, Oviedo, Florida, 32765, United States|Investigational Site Number 840178, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840181, Tampa, Florida, 33613, United States|Investigational Site Number 840420, West Palm Beach, Florida, 33401, United States|Investigational Site Number 840195, Atlanta, Georgia, 30318, United States|Investigational Site Number 840124, Honolulu, Hawaii, 96814, United States|Investigational Site Number 840167, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840163, Nampa, Idaho, 83686, United States|Investigational Site Number 840162, Springfield, Illinois, 62704, United States|Investigational Site Number 840172, Avon, Indiana, 46123, United States|Investigational Site Number 840197, Indianapolis, Indiana, 46202, United States|Investigational Site Number 840108, Des Moines, Iowa, 50314, United States|Investigational Site Number 840407, Iowa City, Iowa, United States|Investigational Site Number 840170, Topeka, Kansas, 66606, United States|Investigational Site Number 840421, Lexington, Kentucky, 40503, United States|Investigational Site Number 840426, Metairie, Louisiana, 70006, United States|Investigational Site Number 840104, Baltimore, Maryland, 21237, United States|Investigational Site Number 840180, Rockville, Maryland, 20852, United States|Investigational Site Number 840137, Haverhill, Massachusetts, 1830, United States|Investigational Site Number 840408, Detroit, Michigan, 48202, United States|Investigational Site Number 840153, Madison Heights, Michigan, 48071, United States|Investigational Site Number 840171, St Louis Park, Minnesota, 55416, United States|Investigational Site Number 840184, St Louis, Missouri, 63110, United States|Investigational Site Number 840106, Omaha, Nebraska, 68131, United States|Investigational Site Number 840145, Omaha, Nebraska, 68131, United States|Investigational Site Number 840139, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840151, Albuquerque, New Mexico, 87106, United States|Investigational Site Number 840191, New Hyde Park, New York, 11042, United States|Investigational Site Number 840173, Syracuse, New York, 13210, United States|Investigational Site Number 840133, Asheville, North Carolina, 28803, United States|Investigational Site Number 840175, Chapel Hill, North Carolina, 27599-7295, United States|Investigational Site Number 840161, Morganton, North Carolina, 28655, United States|Investigational Site Number 840169, Mentor, Ohio, 44060, United States|Investigational Site Number 840119, Norman, Oklahoma, 73069, United States|Investigational Site Number 840112, Bend, Oregon, 97701, United States|Investigational Site Number 840136, Greer, South Carolina, 29651, United States|Investigational Site Number 840122, Dakota Dunes, South Dakota, 57049, United States|Investigational Site Number 840144, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840187, Nashville, Tennessee, 37232, United States|Investigational Site Number 840109, Austin, Texas, 78731, United States|Investigational Site Number 840157, Austin, Texas, 78731, United States|Investigational Site Number 840150, Dallas, Texas, 75230, United States|Investigational Site Number 840412, Dallas, Texas, 75231, United States|Investigational Site Number 840130, Houston, Texas, 77030, United States|Investigational Site Number 840141, Houston, Texas, 77095, United States|Investigational Site Number 840166, San Antonio, Texas, 78229, United States|Investigational Site Number 840101, Murray, Utah, 84123, United States|Investigational Site Number 840125, Burke, Virginia, 22015, United States|Investigational Site Number 840427, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840103, Manassas, Virginia, 20110, United States|Investigational Site Number 840132, Renton, Washington, 98055, United States|Investigational Site Number 840403, Seattle, Washington, 98195, United States|Investigational Site Number 840402, Spokane, Washington, 99220, United States|Investigational Site Number 840127, Tacoma, Washington, 98415-0299, United States|Investigational Site Number 840411, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 124110, Coquitlam, V3K 3P4, Canada|Investigational Site Number 124104, Laval, H7T 2P5, Canada|Investigational Site Number 124108, Mirabel, J7J 2K8, Canada|Investigational Site Number 124109, Montreal, H1Y 3L1, Canada|Investigational Site Number 124105, Thornhill, L4J 8L7, Canada|Investigational Site Number 124101, Toronto, M4R 2G4, Canada|Investigational Site Number 203102, Brno, 62500, Czech Republic|Investigational Site Number 203104, Praha 10, 10034, Czech Republic|Investigational Site Number 203103, Praha 8, 18100, Czech Republic|Investigational Site Number 208103, Esbjerg, 6700, Denmark|Investigational Site Number 208105, Gentofte, 2900, Denmark|Investigational Site Number 208104, København Nv, 2400, Denmark|Investigational Site Number 208107, Køge, 4600, Denmark|Investigational Site Number 208102, Ålborg, 9100, Denmark|Investigational Site Number 233104, Pärnu, 80018, Estonia|Investigational Site Number 233105, Tallinn, 13419, Estonia|Investigational Site Number 233106, Tartu, 50406, Estonia|Investigational Site Number 233101, Tartu, 50410, Estonia|Investigational Site Number 233103, Viljandimaa, 71024, Estonia|Investigational Site Number 246102, Kokkola, 67100, Finland|Investigational Site Number 246101, Kuopio, 70210, Finland|Investigational Site Number 246106, Loimaa, 32200, Finland|Investigational Site Number 246105, Oulu, 90100, Finland|Investigational Site Number 246103, Tampere, 33100, Finland|Investigational Site Number 348103, Budapest, 1036, Hungary|Investigational Site Number 348108, Budapest, 1083, Hungary|Investigational Site Number 348107, Budapest, 1088, Hungary|Investigational Site Number 348106, Debrecen, 4031, Hungary|Investigational Site Number 348102, Gyula, 5700, Hungary|Investigational Site Number 348101, Urhida, 8142, Hungary|Investigational Site Number 392110, Aisai-Shi, Japan|Investigational Site Number 392105, Ise-Shi, Japan|Investigational Site Number 392104, Karatsu-Shi, Japan|Investigational Site Number 392111, Kitakyushu-Shi, Japan|Investigational Site Number 392112, Matsumoto-Shi, Japan|Investigational Site Number 392108, Matumoto, Japan|Investigational Site Number 392103, Midori-Shi, Japan|Investigational Site Number 392107, Mito-Shi, Japan|Investigational Site Number 392101, Sakai-Shi, Japan|Investigational Site Number 392102, Tomishiro, Japan|Investigational Site Number 392106, Yamagata-Shi, Japan|Investigational Site Number 428106, Limbazi, LV-4001, Latvia|Investigational Site Number 428103, Riga, LV-1002, Latvia|Investigational Site Number 428105, Riga, LV-1050, Latvia|Investigational Site Number 428102, Sigulda, LV-2150, Latvia|Investigational Site Number 428101, Ventspils, LV-3601, Latvia|Investigational Site Number 528101, Almere, 1311 RL, Netherlands|Investigational Site Number 528103, Beek, 6191 JW, Netherlands|Investigational Site Number 528105, Nijmegen, 6525 GA, Netherlands|Investigational Site Number 528104, Venlo, 5912 BL, Netherlands|Investigational Site Number 528102, Zwijndrecht, 3331 LZ, Netherlands|Investigational Site Number 840602, Ponce, 00717, Puerto Rico|Investigational Site Number 642107, Bacau, 600164, Romania|Investigational Site Number 642103, Brasov, 500365, Romania|Investigational Site Number 642109, Oradea, 410169, Romania|Investigational Site Number 642106, Resita, 320076, Romania|Investigational Site Number 642104, Sibiu, 550371, Romania|Investigational Site Number 642101, Targu Mures, 540142, Romania|Investigational Site Number 642102, Targu Mures, 540142, Romania|Investigational Site Number 642105, Timisoara, 300133, Romania|Investigational Site Number 642108, Timisoara, 300456, Romania|Investigational Site Number 752103, Goteborg, 41345, Sweden|Investigational Site Number 752105, Kristianstad, 29185, Sweden|Investigational Site Number 752101, Stockholm, 11526, Sweden|Investigational Site Number 752104, Vällingby, 16268, Sweden
URL: https://clinicaltrials.gov/show/NCT01683266

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress