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Clinical Trial Details

Trial ID: L7360
Source ID: NCT02787551
Associated Drug: Insulin Glargine/Lixisenatide Fixed Ratio Combination
Title: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period
Acronym: LixiLan-G
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02787551/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine/lixisenatide fixed ratio combination|DRUG: liraglutide|DRUG: exenatide|DRUG: exenatide extended-release|DRUG: albiglutide|DRUG: dulaglutide|DRUG: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Outcome Measures: Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period, Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period., Baseline, Week 26|Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period, Change in HbA1c was calculated by subtracting baseline value from Week 52 value., Baseline, Week 52 | Secondary: Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period, Participants without any available HbA1c assessment at Week 26 were considered as non-responders., Week 26|Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period, Participants without any available HbA1c assessment at Week 52 were considered as non-responders., Week 52|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period, Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period., Baseline, Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period, Change in FPG was calculated by subtracting baseline value from Week 52 value., Baseline, Week 52|Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period, The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period., Baseline, Week 26|Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period, The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal., Baseline, Week 52|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period, The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF)., Baseline, Week 26|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period, The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF., Baseline, Week 52|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period, 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF., Baseline, Week 26|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period, 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF., Baseline, Week 52|Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period, Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%., From Baseline to Week 26|Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period, Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c \>8%., From Week 26 to Week 52|Change From Baseline in Body Weight at Week 26: Core Period, Change in body weight was calculated by subtracting baseline value from Week 26 value., Baseline, Week 26|Change From Baseline in Body Weight to Week 52: Single Arm Extension Period, Change in body weight was calculated by subtracting baseline value from Week 52 value., Baseline, Week 52|Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period, Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed., From Baseline to Week 26|Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period, Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of \<3.0 mmol/L (54 mg/dL) were also analyzed., From Baseline to Week 52
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 514
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-07-06
Completion Date: 2018-11-17
Results First Posted: 2019-06-12
Last Update Posted: 2022-03-25
Locations: Investigational Site Number 8400064, Birmingham, Alabama, 35205, United States|Investigational Site Number 8400073, Fountain Hills, Arizona, 85268, United States|Investigational Site Number 8400047, Phoenix, Arizona, 85028, United States|Investigational Site Number 8400103, Bakersfield, California, 93309, United States|Investigational Site Number 8400137, Fresno, California, 93720, United States|Investigational Site Number 8400043, Huntington Park, California, 90255, United States|Investigational Site Number 8400124, Lamont, California, 93241, United States|Investigational Site Number 8400027, Lancaster, California, 93534, United States|Investigational Site Number 8400098, Los Angeles, California, 90017, United States|Investigational Site Number 8400013, Los Angeles, California, 90057, United States|Investigational Site Number 8400042, Mission Hills, California, 91345, United States|Investigational Site Number 8400006, Northridge, California, 91325, United States|Investigational Site Number 8400021, Orange, California, 92868, United States|Investigational Site Number 8400126, Rialto, California, 92377, United States|Investigational Site Number 8400094, Santa Ana, California, 92704, United States|Investigational Site Number 8400009, Ventura, California, 93003, United States|Investigational Site Number 8400071, Denver, Colorado, 80209, United States|Investigational Site Number 8400036, Denver, Colorado, 80246, United States|Investigational Site Number 8400114, Jacksonville, Florida, 32216, United States|Investigational Site Number 8400133, Miami, Florida, 33165, United States|Investigational Site Number 8400058, Port Charlotte, Florida, 33952, United States|Investigational Site Number 8400084, Tampa, Florida, 33612, United States|Investigational Site Number 8400112, West Palm Beach, Florida, 33401, United States|Investigational Site Number 8400045, Lawrenceville, Georgia, 30046, United States|Investigational Site Number 8400096, Snellville, Georgia, 30078, United States|Investigational Site Number 8400023, Springfield, Illinois, 62711, United States|Investigational Site Number 8400049, Avon, Indiana, 46123, United States|Investigational Site Number 8400053, Avon, Indiana, 46123, United States|Investigational Site Number 8400085, Avon, Indiana, 46123, United States|Investigational Site Number 8400120, Avon, Indiana, 46123, United States|Investigational Site Number 8400041, Evansville, Indiana, 47714, United States|Investigational Site Number 8400038, Indianapolis, Indiana, 46254-5469, United States|Investigational Site Number 8400130, Council Bluffs, Iowa, 51501, United States|Investigational Site Number 8400034, Lexington, Kentucky, 40503, United States|Investigational Site Number 8400091, Lexington, Kentucky, 40503, United States|Investigational Site Number 8400078, Marrero, Louisiana, 70072, United States|Investigational Site Number 8400032, Metairie, Louisiana, 70006, United States|Investigational Site Number 8400088, New Orleans, Louisiana, 70121, United States|Investigational Site Number 8400033, Baltimore, Maryland, 21237, United States|Investigational Site Number 8400051, Jefferson City, Missouri, 65109, United States|Investigational Site Number 8400083, Papillion, Nebraska, 68046-3136, United States|Investigational Site Number 8400044, Henderson, Nevada, 89052, United States|Investigational Site Number 8400079, Albany, New York, 12206, United States|Investigational Site Number 8400061, New York, New York, 10001, United States|Investigational Site Number 8400123, North Massapequa, New York, 11758, United States|Investigational Site Number 8400095, Staten Island, New York, 10301, United States|Investigational Site Number 8400067, West Seneca, New York, 14224, United States|Investigational Site Number 8400111, Yonkers, New York, 10704, United States|Investigational Site Number 8400020, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400065, Wilmington, North Carolina, 28401, United States|Investigational Site Number 8400018, Fargo, North Dakota, 58104, United States|Investigational Site Number 8400019, Columbus, Ohio, 43201, United States|Investigational Site Number 8400056, Dayton, Ohio, 45439, United States|Investigational Site Number 8400125, Mentor, Ohio, 44060, United States|Investigational Site Number 8400099, Oklahoma City, Oklahoma, 73112, United States|Investigational Site Number 8400129, Scottdale, Pennsylvania, 15683, United States|Investigational Site Number 8400076, Smithfield, Pennsylvania, 15478, United States|Investigational Site Number 8400104, Warwick, Rhode Island, 02886, United States|Investigational Site Number 8400090, Columbia, South Carolina, 29204, United States|Investigational Site Number 8400139, Austin, Texas, 78749, United States|Investigational Site Number 8400001, Dallas, Texas, 75230-6885, United States|Investigational Site Number 8400118, Edinburg, Texas, 78539, United States|Investigational Site Number 8400008, Houston, Texas, 77004, United States|Investigational Site Number 8400109, Houston, Texas, 77040, United States|Investigational Site Number 8400063, Houston, Texas, 77061, United States|Investigational Site Number 8400106, Houston, Texas, 77081, United States|Investigational Site Number 8400014, North Richland Hills, Texas, 76180, United States|Investigational Site Number 8400089, San Antonio, Texas, 78240, United States|Investigational Site Number 8400135, Schertz, Texas, 78154, United States|Investigational Site Number 8400075, Shavano Park, Texas, 78231, United States|Investigational Site Number 8400107, Sugar Land, Texas, 77478, United States|Investigational Site Number 8400054, Orem, Utah, 84058, United States|Investigational Site Number 8400025, Salt Lake City, Utah, 84102, United States|Investigational Site Number 8400092, Weber City, Virginia, 24290, United States|Investigational Site Number 1240003, Burlington, L7M 4Y1, Canada|Investigational Site Number 1240006, Corunna, N0N 1G0, Canada|Investigational Site Number 1240002, Red Deer, T4N 6V7, Canada|Investigational Site Number 1240001, Vancouver, V5Y 3W2, Canada|Investigational Site Number 2330002, Pärnu, 80018, Estonia|Investigational Site Number 2330003, Tallinn, 10138, Estonia|Investigational Site Number 2330001, Tallinn, 13419, Estonia|Investigational Site Number 2330004, Viljandi, 71024, Estonia|Investigational Site Number 2760001, Dresden, 01307, Germany|Investigational Site Number 2760003, Oldenburg In Holstein, 23758, Germany|Investigational Site Number 3760001, Haifa, 31096, Israel|Investigational Site Number 3760002, Haifa, 35152, Israel|Investigational Site Number 3760005, Jerusalem, 91120, Israel|Investigational Site Number 3760006, Jerusalem, 93106, Israel|Investigational Site Number 3760004, Tel Aviv, 6203854, Israel|Investigational Site Number 3800008, Bergamo, 24127, Italy|Investigational Site Number 3800002, Bologna, 40138, Italy|Investigational Site Number 3800001, Milano, 20132, Italy|Investigational Site Number 3800006, Milano, 20142, Italy|Investigational Site Number 3800005, Napoli, 80131, Italy|Investigational Site Number 3800004, Roma, 00128, Italy|Investigational Site Number 3800003, Roma, 00133, Italy|Investigational Site Number 6420004, Bacau, 600154, Romania|Investigational Site Number 6420006, Brasov, 500097, Romania|Investigational Site Number 6420001, Bucuresti, 020045, Romania|Investigational Site Number 6420008, Buzau, 120203, Romania|Investigational Site Number 6420003, Cluj Napoca, 400006, Romania|Investigational Site Number 6420002, Oradea, 410159, Romania|Investigational Site Number 6420009, Targoviste, 130083, Romania|Investigational Site Number 6420005, Timisoara, 300125, Romania|Investigational Site Number 6420007, Târgu-Mureş, 540098, Romania|Investigational Site Number 7030006, Bratislava, 85101, Slovakia|Investigational Site Number 7030009, Lubochna, 034 91, Slovakia|Investigational Site Number 7030002, Lucenec, 98401, Slovakia|Investigational Site Number 7030005, Malacky, 90101, Slovakia|Investigational Site Number 7030007, Presov, 08001, Slovakia|Investigational Site Number 7030001, Roznava, 04801, Slovakia|Investigational Site Number 7030008, Sabinov, 083 01, Slovakia|Investigational Site Number 7030004, Trencin, 91101, Slovakia|Investigational Site Number 7030003, Zilina, 010 01, Slovakia|Investigational Site Number 7240012, Alzira, 46600, Spain|Investigational Site Number 7240005, Barcelona, 08035, Spain|Investigational Site Number 7240002, Ferrol, 15405, Spain|Investigational Site Number 7240008, Málaga, 29010, Spain|Investigational Site Number 7240011, Pozuelo De Alarcón, 28223, Spain|Investigational Site Number 7240003, Quart De Poblet, 46930, Spain|Investigational Site Number 7240006, Sabadell, 08208, Spain|Investigational Site Number 7240007, Sevilla, 41003, Spain|Investigational Site Number 7240009, sEVILLA, 41010, Spain|Investigational Site Number 7240004, Sevilla, 41071, Spain
URL: https://clinicaltrials.gov/show/NCT02787551

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details