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Clinical Trial Details

Trial ID: L1953
Source ID: NCT02058160
Associated Drug: Insulin Glargine/Lixisenatide (Hoe901/Ave0010)
Title: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
Acronym: LixiLan-L
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02058160/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin glargine/lixisenatide (HOE901/AVE0010)|DRUG: Insulin glargine (HOE901)|DRUG: Metformin (Background Drug)
Outcome Measures: Primary: Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30, Change in HbA1c was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30 | Secondary: Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30, Week 30|Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30, Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Change in Body Weight From Baseline to Week 30, Change in body weight was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30, Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach., Baseline, Week 30|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30, Week 30|Change in Daily Insulin Glargine Dose From Baseline to Week 30, Baseline, Week 30|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L)., Baseline up to Week 30|Change in FPG From Baseline to Week 30, Change in FPG was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Change in 2-hour PPG From Baseline to Week 30, Change in PPG was calculated by subtracting baseline value from Week 30 value., Baseline, Week 30|Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L)., Baseline up to Week 30|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period, Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8%., Baseline up to Week 30|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L)., First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Percentage of Participants With Documented Symptomatic Hypoglycemia, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L)., First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Percentage of Participants With Severe Symptomatic Hypoglycemia, Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others., First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 736
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-01
Completion Date: 2015-07
Results First Posted: 2017-02-10
Last Update Posted: 2017-05-09
Locations: Investigational Site Number 840607, Birmingham, Alabama, 35205, United States|Investigational Site Number 840570, Sun City, Arizona, 85351, United States|Investigational Site Number 840562, Tempe, Arizona, United States|Investigational Site Number 840577, Tucson, Arizona, 85723, United States|Investigational Site Number 840517, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840537, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840568, Bell Gardens, California, 90201, United States|Investigational Site Number 840550, Chino, California, 91710, United States|Investigational Site Number 840529, Chula Vista, California, 91911, United States|Investigational Site Number 840623, Corona, California, 92879, United States|Investigational Site Number 840566, Fresno, California, 93720, United States|Investigational Site Number 840552, Greenbrae, California, 94904, United States|Investigational Site Number 840578, Lancaster, California, 93534, United States|Investigational Site Number 840626, Los Angeles, California, 90017, United States|Investigational Site Number 840581, Los Angeles, California, 90057, United States|Investigational Site Number 840621, Mission Viejo, California, 92691, United States|Investigational Site Number 840511, Northridge, California, 91325, United States|Investigational Site Number 840573, Palm Springs, California, 92262, United States|Investigational Site Number 840559, Port Hueneme, California, 93041, United States|Investigational Site Number 840536, San Ramon, California, 94583, United States|Investigational Site Number 840567, Santa Ana, California, 92704, United States|Investigational Site Number 840569, Tarzana, California, 91356, United States|Investigational Site Number 840572, West Hills, California, 91345, United States|Investigational Site Number 840582, Aurora, Colorado, 80045, United States|Investigational Site Number 840509, Denver, Colorado, 80246, United States|Investigational Site Number 840549, Wilmington, Delaware, 19713, United States|Investigational Site Number 840510, Miami, Florida, 33156-7563, United States|Investigational Site Number 840521, New Port Richey, Florida, 34652, United States|Investigational Site Number 840602, Ocala, Florida, 34471, United States|Investigational Site Number 840538, Ocoee, Florida, 34761, United States|Investigational Site Number 840534, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840594, Atlanta, Georgia, 30322, United States|Investigational Site Number 840614, Columbus, Georgia, 31904, United States|Investigational Site Number 840501, Lawrenceville, Georgia, 30046, United States|Investigational Site Number 840525, Roswell, Georgia, 30076, United States|Investigational Site Number 840588, Idaho Falls, Idaho, 83404, United States|Investigational Site Number 840580, Arlington Heights, Illinois, 60005, United States|Investigational Site Number 840519, Chicago, Illinois, 60607, United States|Investigational Site Number 840612, Chicago, Illinois, 60616, United States|Investigational Site Number 840556, Springfield, Illinois, 62704, United States|Investigational Site Number 840543, Avon, Indiana, 46123, United States|Investigational Site Number 840565, Evansville, Indiana, 47713, United States|Investigational Site Number 840585, Evansville, Indiana, 47714, United States|Investigational Site Number 840615, Evansville, Indiana, 47714, United States|Investigational Site Number 840563, Indianapolis, Indiana, 46202, United States|Investigational Site Number 840507, Indianapolis, Indiana, 46260, United States|Investigational Site Number 840516, Louisville, Kentucky, 40213, United States|Investigational Site Number 840595, Lewiston, Maine, 04240, United States|Investigational Site Number 840520, Baltimore, Maryland, 21237, United States|Investigational Site Number 840560, Baltimore, Maryland, 21237, United States|Investigational Site Number 840522, Rockville, Maryland, 20852, United States|Investigational Site Number 840505, Dearborn, Michigan, 48124, United States|Investigational Site Number 840575, Flint, Michigan, 48504, United States|Investigational Site Number 840564, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840558, Butte, Montana, 59701, United States|Investigational Site Number 840506, Omaha, Nebraska, 68131, United States|Investigational Site Number 840600, Henderson, Nevada, 89074, United States|Investigational Site Number 840532, Las Vegas, Nevada, 89119, United States|Investigational Site Number 840599, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840539, Nashua, New Hampshire, 03063, United States|Investigational Site Number 840576, Albuquerque, New Mexico, 87131, United States|Investigational Site Number 840583, Jamaica, New York, 11432, United States|Investigational Site Number 840531, New Hyde Park, New York, 11042, United States|Investigational Site Number 840557, Syracuse, New York, 13214-2016, United States|Investigational Site Number 840541, Durham, North Carolina, 27710, United States|Investigational Site Number 840604, Greenville, North Carolina, 27858, United States|Investigational Site Number 840540, Hickory, North Carolina, 28601, United States|Investigational Site Number 840513, Morehead City, North Carolina, 28557, United States|Investigational Site Number 840592, Salisbury, North Carolina, 28144, United States|Investigational Site Number 840535, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840515, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 840579, Columbus, Ohio, 43213, United States|Investigational Site Number 840524, Dayton, Ohio, 45439, United States|Investigational Site Number 840503, Maumee, Ohio, 43537, United States|Investigational Site Number 840618, Eugene, Oregon, 97404, United States|Investigational Site Number 840610, Philadelphia, Pennsylvania, 19107, United States|Investigational Site Number 840551, Smithfield, Pennsylvania, 15478, United States|Investigational Site Number 840584, Tipton, Pennsylvania, 16684, United States|Investigational Site Number 840622, Charleston, South Carolina, 29407, United States|Investigational Site Number 840611, Rapid City, South Dakota, 57701, United States|Investigational Site Number 840605, Amarillo, Texas, 79106, United States|Investigational Site Number 840553, Austin, Texas, 78731, United States|Investigational Site Number 840598, Austin, Texas, 78731, United States|Investigational Site Number 840502, Corpus Christi, Texas, 78404, United States|Investigational Site Number 840601, Dallas, Texas, 75208, United States|Investigational Site Number 840586, Dallas, Texas, 75216, United States|Investigational Site Number 840547, Dallas, Texas, 75230, United States|Investigational Site Number 840530, Dallas, Texas, 75231, United States|Investigational Site Number 840545, Dallas, Texas, 75246, United States|Investigational Site Number 840554, Edinburg, Texas, 78539, United States|Investigational Site Number 840544, Houston, Texas, 77030, United States|Investigational Site Number 840514, Hurst, Texas, 76054, United States|Investigational Site Number 840617, N Richland Hill, Texas, 76180, United States|Investigational Site Number 840512, Draper, Utah, 84020, United States|Investigational Site Number 840591, Murray, Utah, 84123, United States|Investigational Site Number 840526, Ogden, Utah, 84405, United States|Investigational Site Number 840597, Orem, Utah, 84058, United States|Investigational Site Number 840590, Salt Lake City, Utah, 84102, United States|Investigational Site Number 840613, Burlington, Vermont, 05401, United States|Investigational Site Number 840504, Chesapeake, Virginia, 23321, United States|Investigational Site Number 840561, Norfolk, Virginia, 23510, United States|Investigational Site Number 840625, Norfolk, Virginia, 23510, United States|Investigational Site Number 840606, Richmond, Virginia, 23227, United States|Investigational Site Number 840608, Salem, Virginia, 24153, United States|Investigational Site Number 840571, Federal Way, Washington, 98003, United States|Investigational Site Number 840593, Spokane, Washington, 99220, United States|Investigational Site Number 840609, Tacoma, Washington, 98415-0299, United States|Investigational Site Number 840546, Milwaukee, Wisconsin, 53209-0996, United States|Investigational Site Number 036505, Box Hill, 3128, Australia|Investigational Site Number 036501, Heidelberg, 3081, Australia|Investigational Site Number 036504, Parkville, 3050, Australia|Investigational Site Number 124504, Beamsville, L0R 1B0, Canada|Investigational Site Number 124512, Brampton, L6R 3J5, Canada|Investigational Site Number 124502, Guelph, N1H 1B1, Canada|Investigational Site Number 124507, Kelowna, V1Y 1Z9, Canada|Investigational Site Number 124505, Montreal, H1W 2R7, Canada|Investigational Site Number 124511, Oakville, L6H 3P1, Canada|Investigational Site Number 124509, St-Romuald, G6W 5M6, Canada|Investigational Site Number 124503, Toronto, M9V 4B4, Canada|Investigational Site Number 124510, Toronto, M9W 4L9, Canada|Investigational Site Number 124501, Vancouver, V5Y 3W2, Canada|Investigational Site Number 124508, Victoria, V8V 4A1, Canada|Investigational Site Number 152511, Puerto Varas, 5480000, Chile|Investigational Site Number 152502, Santiago, 7500347, Chile|Investigational Site Number 152501, Santiago, 7500710, Chile|Investigational Site Number 152514, Santiago, 7500739, Chile|Investigational Site Number 152503, Santiago, 8053095, Chile|Investigational Site Number 152507, Santiago, Chile|Investigational Site Number 152509, Talagante, Chile|Investigational Site Number 152513, Temuco, 4780000, Chile|Investigational Site Number 152504, Vina Del Mar, Chile|Investigational Site Number 203502, Cheb, 35002, Czech Republic|Investigational Site Number 203504, Hranice, 75301, Czech Republic|Investigational Site Number 203507, Krnov, 79401, Czech Republic|Investigational Site Number 203506, Liberec, 460 01, Czech Republic|Investigational Site Number 203503, Olomouc, 77900, Czech Republic|Investigational Site Number 203514, Plzen, 301 66, Czech Republic|Investigational Site Number 203515, Plzen, 301 66, Czech Republic|Investigational Site Number 203511, Praha 4, 14900, Czech Republic|Investigational Site Number 203508, Praha 5, 15030, Czech Republic|Investigational Site Number 203509, Praha 8, 18100, Czech Republic|Investigational Site Number 203505, Prostejov, 79601, Czech Republic|Investigational Site Number 208503, Aarhus C, 8000, Denmark|Investigational Site Number 208509, Horsens, 8700, Denmark|Investigational Site Number 208502, Kolding, 6000, Denmark|Investigational Site Number 208501, København Nv, 2400, Denmark|Investigational Site Number 208505, København S, 2300, Denmark|Investigational Site Number 208504, Viborg, 8800, Denmark|Investigational Site Number 233502, Pärnu, 80018, Estonia|Investigational Site Number 233503, Tallinn, 10138, Estonia|Investigational Site Number 233501, Tartu, 50406, Estonia|Investigational Site Number 348503, Budapest, 1134, Hungary|Investigational Site Number 348501, Budapest, 1138, Hungary|Investigational Site Number 348505, Budapest, 1212, Hungary|Investigational Site Number 348502, Debrecen, 4031, Hungary|Investigational Site Number 348506, Kaposvár, 7400, Hungary|Investigational Site Number 348504, Pápa, 8500, Hungary|Investigational Site Number 440501, Kaunas, 48259, Lithuania|Investigational Site Number 440503, Kaunas, 49449, Lithuania|Investigational Site Number 440505, Kedainiai, LT-57164, Lithuania|Investigational Site Number 440504, Klaipeda, LT-92253, Lithuania|Investigational Site Number 440502, Vilnius, LT-10323, Lithuania|Investigational Site Number 484508, Celaya, 38000, Mexico|Investigational Site Number 484501, Cuernavaca, 62250, Mexico|Investigational Site Number 484503, Guadalajara, 44130, Mexico|Investigational Site Number 484504, Guadalajara, 44210, Mexico|Investigational Site Number 484506, Guadalajara, 44600, Mexico|Investigational Site Number 484509, México, 06700, Mexico|Investigational Site Number 484507, Pachuca, 42084, Mexico|Investigational Site Number 484505, Puebla, 72190, Mexico|Investigational Site Number 528505, Almere, 1311 RL, Netherlands|Investigational Site Number 616502, Bialystok, 15-435, Poland|Investigational Site Number 616505, Krakow, 31-261, Poland|Investigational Site Number 616506, Krakow, 31-548, Poland|Investigational Site Number 616507, Plock, 09-400, Poland|Investigational Site Number 616504, Szczecin, 70-506, Poland|Investigational Site Number 616503, Warszawa, 01-518, Poland|Investigational Site Number 616501, Warszawa, 02-507, Poland|Investigational Site Number 642507, Brasov, 500365, Romania|Investigational Site Number 642510, Bucharest, 010825, Romania|Investigational Site Number 642508, Bucuresti, 020042, Romania|Investigational Site Number 642509, Bucuresti, 020475, Romania|Investigational Site Number 642506, Hunedoara, 331057, Romania|Investigational Site Number 642505, Iasi, 700547, Romania|Investigational Site Number 642502, Oradea, 410169, Romania|Investigational Site Number 642511, Sibiu, 550371, Romania|Investigational Site Number 642501, Targu Mures, 540142, Romania|Investigational Site Number 642504, Timisoara, 300125, Romania|Investigational Site Number 642503, Timisoara, 300456, Romania|Investigational Site Number 643511, Arkhangelsk, 163045, Russian Federation|Investigational Site Number 643512, Moscow, 119435, Russian Federation|Investigational Site Number 643508, Penza, 440026, Russian Federation|Investigational Site Number 643501, Saint-Petersburg, 190013, Russian Federation|Investigational Site Number 643513, Samara, 443041, Russian Federation|Investigational Site Number 643507, Saratov, 410030, Russian Federation|Investigational Site Number 643514, Saratov, 410053, Russian Federation|Investigational Site Number 643506, St-Petersburg, 194291, Russian Federation|Investigational Site Number 643503, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643504, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643502, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643505, St. Petersburg, 194358, Russian Federation|Investigational Site Number 643509, Voronezh, 394018, Russian Federation|Investigational Site Number 703505, Bratislava, 85101, Slovakia|Investigational Site Number 703507, Bytca, 01401, Slovakia|Investigational Site Number 703502, Kosice, 04001, Slovakia|Investigational Site Number 703512, Kosice, 04001, Slovakia|Investigational Site Number 703510, Kosice, 04013, Slovakia|Investigational Site Number 703511, Lubochna, 3491, Slovakia|Investigational Site Number 703508, Moldava Nad Bodvou, 04525, Slovakia|Investigational Site Number 703504, Nove Mesto Nad Vahom, 91501, Slovakia|Investigational Site Number 703509, Nove Zamky, 94001, Slovakia|Investigational Site Number 703513, Trnava, 91701, Slovakia|Investigational Site Number 703501, Zilina, 01001, Slovakia|Investigational Site Number 724509, Alicante, 03010, Spain|Investigational Site Number 724506, Alzira, 46600, Spain|Investigational Site Number 724504, Barcelona, 08035, Spain|Investigational Site Number 724510, Barcelona, 08036, Spain|Investigational Site Number 724505, Cáceres, 10003, Spain|Investigational Site Number 724503, El Ferrol, 15405, Spain|Investigational Site Number 724508, La Coruña, 15006, Spain|Investigational Site Number 724501, Sabadell, 08208, Spain|Investigational Site Number 724507, Segovia, 40002, Spain|Investigational Site Number 724502, Valencia, 46014, Spain|Investigational Site Number 752501, Ljungby, 341 82, Sweden|Investigational Site Number 752503, Malmö, 211 52, Sweden|Investigational Site Number 752504, Rättvik, 79530, Sweden|Investigational Site Number 752506, Stenungssund, 44431, Sweden|Investigational Site Number 752505, Stockholm, 11526, Sweden|Investigational Site Number 752502, Vällingby, 16268, Sweden|Investigational Site Number 804501, Chernivtsi, 58022, Ukraine|Investigational Site Number 804510, Kyiv, 03049, Ukraine|Investigational Site Number 804507, Kyiv, 04050, Ukraine|Investigational Site Number 804511, Kyiv, Ukraine|Investigational Site Number 804513, Lviv, 79010, Ukraine|Investigational Site Number 804502, Vinnytsya, 21001, Ukraine|Investigational Site Number 804508, Vinnytsya, 21010, Ukraine
URL: https://clinicaltrials.gov/show/NCT02058160

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details