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Clinical Trial Details

Trial ID: L4612
Source ID: NCT03434119
Associated Drug: Insulin Glargine/Lixisenatide
Title: Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
Acronym: LixiLan-D
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03434119/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine/Lixisenatide|DRUG: Insulin glargine (HOE901)|DRUG: Background therapy
Outcome Measures: Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26, Change in HbA1c was calculated by subtracting baseline value from Week 26 value., Baseline, Week 26 | Secondary: Percentage of Participants Achieving HbA1c Target of <7% at Week 26, Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders., Week 26|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26, The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal., Baseline, Week 26|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26, Baseline, Week 26|Change From Baseline in Daily Insulin Glargine Dose at Week 26, Change in daily dose was calculated by subtracting baseline value from Week 26 value., Baseline, Week 26|Change From Baseline in Body Weight at Week 26, Change in body weight was calculated by subtracting baseline value from Week 26 value., Baseline, Week 26|Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period, Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<54 mg/dL (3.0 mmol/L) regardless of symptoms., Baseline to Week 26
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 241
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-02-20
Completion Date: 2019-01-07
Results First Posted: 2020-01-13
Last Update Posted: 2022-03-28
Locations: Investigational Site Number 8400072, Montgomery, Alabama, 36106, United States|Investigational Site Number 8400077, Little Rock, Arkansas, 72204, United States|Investigational Site Number 8400095, Little Rock, Arkansas, 72205, United States|Investigational Site Number 8400013, Little Rock, Arkansas, 72211, United States|Investigational Site Number 8400076, Anaheim, California, 92801-4123, United States|Investigational Site Number 8400052, Anaheim, California, 92801, United States|Investigational Site Number 8400069, Anaheim, California, 92805, United States|Investigational Site Number 8400060, Burbank, California, 91505, United States|Investigational Site Number 8400049, Cerritos, California, 90703, United States|Investigational Site Number 8400078, Chula Vista, California, 91910, United States|Investigational Site Number 8400047, Escondido, California, 92025, United States|Investigational Site Number 8400066, Fountain Valley, California, 92708, United States|Investigational Site Number 8400050, Greenbrae, California, 94904, United States|Investigational Site Number 8400092, Huntington Park, California, 90255, United States|Investigational Site Number 8400015, Los Angeles, California, 90017, United States|Investigational Site Number 8400011, Los Angeles, California, 90057, United States|Investigational Site Number 8400301, Los Angeles, California, 90094, United States|Investigational Site Number 8400302, Los Angeles, California, 90094, United States|Investigational Site Number 8400303, Los Angeles, California, 90094, United States|Investigational Site Number 8400304, Los Angeles, California, 90094, United States|Investigational Site Number 8400006, Los Gatos, California, 95032, United States|Investigational Site Number 8400048, Oakland, California, 94612, United States|Investigational Site Number 8400053, Orange, California, 92868, United States|Investigational Site Number 8400084, Pomona, California, 91766, United States|Investigational Site Number 8400081, Pomona, California, 91767, United States|Investigational Site Number 8400042, Rancho Cucamonga, California, 91730, United States|Investigational Site Number 8400063, San Carlos, California, 94070, United States|Investigational Site Number 8400091, San Diego, California, 92114, United States|Investigational Site Number 8400086, San Jose, California, 95148, United States|Investigational Site Number 8400074, Santa Ana, California, 92701, United States|Investigational Site Number 8400037, Temecula, California, 92591, United States|Investigational Site Number 8400087, Vallejo, California, 94592, United States|Investigational Site Number 8400024, Van Nuys, California, 91405, United States|Investigational Site Number 8400007, Ventura, California, 93003, United States|Investigational Site Number 8400054, Englewood, Colorado, 80113, United States|Investigational Site Number 8400023, Hamden, Connecticut, 06517, United States|Investigational Site Number 8400041, Gainesville, Florida, 32653, United States|Investigational Site Number 8400075, Jacksonville, Florida, 32204, United States|Investigational Site Number 8400016, Miami Lakes, Florida, 33014, United States|Investigational Site Number 8400036, Miami, Florida, 33144, United States|Investigational Site Number 8400017, Miami, Florida, 33176, United States|Investigational Site Number 8400014, Ocoee, Florida, 34761, United States|Investigational Site Number 8400028, Port Charlotte, Florida, 33952, United States|Investigational Site Number 8400097, Saint Petersburg, Florida, 00000, United States|Investigational Site Number 8400035, Saint Petersburg, Florida, 33713, United States|Investigational Site Number 8400094, Tampa, Florida, 33634, United States|Investigational Site Number 8400025, Atlanta, Georgia, 30303, United States|Investigational Site Number 8400051, Atlanta, Georgia, 30310, United States|Investigational Site Number 8400093, Atlanta, Georgia, 30318, United States|Investigational Site Number 8400005, Savannah, Georgia, 31406-2675, United States|Investigational Site Number 8400038, Chicago, Illinois, 60607, United States|Investigational Site Number 8400088, Chicago, Illinois, 60607, United States|Investigational Site Number 8400031, Des Plaines, Illinois, 60018, United States|Investigational Site Number 8400064, Evanston, Illinois, 60201, United States|Investigational Site Number 8400057, Gurnee, Illinois, 60031, United States|Investigational Site Number 8400030, Gretna, Louisiana, 70053, United States|Investigational Site Number 8400009, New Orleans, Louisiana, 70124, United States|Investigational Site Number 8400065, Baltimore, Maryland, 21237, United States|Investigational Site Number 8400061, Rockville, Maryland, 20852, United States|Investigational Site Number 8400079, Chelsea, Michigan, 48118, United States|Investigational Site Number 8400001, Flint, Michigan, 48504, United States|Investigational Site Number 8400012, Flint, Michigan, 48532-3447, United States|Investigational Site Number 8400090, Las Vegas, Nevada, 89117, United States|Investigational Site Number 8400082, Las Vegas, Nevada, 89148, United States|Investigational Site Number 8400018, Linden, New Jersey, 07036, United States|Investigational Site Number 8400003, Bronx, New York, 10455, United States|Investigational Site Number 8400062, Philadelphia, Pennsylvania, 19107, United States|Investigational Site Number 8400043, Columbia, South Carolina, 29204, United States|Investigational Site Number 8400021, Dallas, Texas, 75230, United States|Investigational Site Number 8400040, Fort Worth, Texas, 76132, United States|Investigational Site Number 8400045, Houston, Texas, 77089, United States|Investigational Site Number 8400002, Humble, Texas, 77338, United States|Investigational Site Number 8400039, Kerrville, Texas, 78028, United States|Investigational Site Number 8400096, Lufkin, Texas, 75904, United States|Investigational Site Number 8400027, San Antonio, Texas, 78228, United States|Investigational Site Number 8400083, San Antonio, Texas, 78230, United States|Investigational Site Number 8400008, Splendora, Texas, 77372, United States|Investigational Site Number 8400055, Spring, Texas, 77379, United States|Investigational Site Number 8400070, Sugar Land, Texas, 77478, United States|Investigational Site Number 8400085, Sugar Land, Texas, 77479, United States|Investigational Site Number 8400059, Webster, Texas, 77598, United States|Investigational Site Number 8400044, Manassas, Virginia, 20110, United States|Investigational Site Number 8400068, Norfolk, Virginia, 23510, United States|Investigational Site Number 8400033, Richmond, Virginia, 23219, United States|Investigational Site Number 8400029, Richland, Washington, 99352, United States
URL: https://clinicaltrials.gov/show/NCT03434119

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress