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Clinical Trial Details

Trial ID: L4696
Source ID: NCT02320721
Associated Drug: Insulin Glargine (Hoe901 - U300)
Title: Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Acronym: SENIOR
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02320721/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin Glargine (HOE901 - U300)|DRUG: Insulin Glargine (HOE901 - U100)|DRUG: Background therapy
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period., Baseline, Week 26 | Secondary: Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period, Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL)., Baseline up to Week 26|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period, Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL)., Baseline up to Week 26|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period, Estimated percentages from multiple imputation approach including data from the 26-week randomized period. 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 ≤3.9 mmol/L (70 mg/dL)., Baseline up to Week 26|Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period, Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses., Baseline up to Week 26|Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period, 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 ≤3.9 mmol/L (70 mg/dL)., Baseline up to Week 26|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period., Baseline, Week 26|Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26, WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life)., Baseline, Week 26|Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment, Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%., Baseline up to Week 26 | Other: Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment, Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L \[70 mg/dL\]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L)., Baseline up to Week 26|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment, Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L \[70 mg/dL\]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L)., Baseline up to Week 26
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE3
Enrollment: 1014
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2016-05
Results First Posted: 2017-07-11
Last Update Posted: 2020-04-21
Locations: Investigational Site Number 840058, Saraland, Alabama, 36571, United States|Investigational Site Number 840019, Fresno, California, 93720, United States|Investigational Site Number 840021, Fresno, California, 93722, United States|Investigational Site Number 840040, Greenbrae, California, 94904, United States|Investigational Site Number 840070, Huntington Park, California, 90255, United States|Investigational Site Number 840064, Los Angeles, California, 90057, United States|Investigational Site Number 840031, Norwalk, California, 90650, United States|Investigational Site Number 840065, Oakland, California, 94612, United States|Investigational Site Number 840050, Orange, California, 92868, United States|Investigational Site Number 840036, Simi Valley, California, 93065, United States|Investigational Site Number 840003, Temecula, California, 92591, United States|Investigational Site Number 840062, Walnut Creek, California, 94598, United States|Investigational Site Number 840027, Longmont, Colorado, 80501, United States|Investigational Site Number 840030, Bradenton, Florida, 34208, United States|Investigational Site Number 840010, Miami, Florida, 33156, United States|Investigational Site Number 840035, Miami, Florida, 33156, United States|Investigational Site Number 840014, New Port Richey, Florida, 34652, United States|Investigational Site Number 840051, Ocoee, Florida, 34761, United States|Investigational Site Number 840056, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840007, Saint Petersburg, Florida, United States|Investigational Site Number 840041, Roswell, Georgia, 30076, United States|Investigational Site Number 840053, Statesboro, Georgia, 30461, United States|Investigational Site Number 840042, Woodstock, Georgia, 30189, United States|Investigational Site Number 840005, Arlington Heights, Illinois, 60005, United States|Investigational Site Number 840004, Peoria, Illinois, 61602, United States|Investigational Site Number 840029, Springfield, Illinois, 62704, United States|Investigational Site Number 840013, Avon, Indiana, 46123, United States|Investigational Site Number 840023, Avon, Indiana, 46123, United States|Investigational Site Number 840039, Evansville, Indiana, 47714, United States|Investigational Site Number 840006, Muncie, Indiana, 47304, United States|Investigational Site Number 840026, Des Moines, Iowa, 50314, United States|Investigational Site Number 840033, West Des Moines, Iowa, 50266, United States|Investigational Site Number 840032, Overland Park, Kansas, 66209, United States|Investigational Site Number 840069, Metairie, Louisiana, 70006, United States|Investigational Site Number 840020, Flint, Michigan, 48504, United States|Investigational Site Number 840037, Nashua, New Hampshire, 03063, United States|Investigational Site Number 840018, New York, New York, 10001, United States|Investigational Site Number 840048, Asheville, North Carolina, 28805, United States|Investigational Site Number 840009, Charlotte, North Carolina, 28209, United States|Investigational Site Number 840011, Greensboro, North Carolina, 27408, United States|Investigational Site Number 840047, Greenville, North Carolina, 27834, United States|Investigational Site Number 840016, Salisbury, North Carolina, 28144, United States|Investigational Site Number 840012, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840022, Fargo, North Dakota, 58103, United States|Investigational Site Number 840072, Cincinnati, Ohio, 45219, United States|Investigational Site Number 840054, Wadsworth, Ohio, 44281, United States|Investigational Site Number 840067, Bend, Oregon, 97702, United States|Investigational Site Number 840057, Corvallis, Oregon, 97330, United States|Investigational Site Number 840045, Feasterville, Pennsylvania, 19053, United States|Investigational Site Number 840017, Pittsburgh, Pennsylvania, 15220, United States|Investigational Site Number 840059, Greenville, South Carolina, 29605, United States|Investigational Site Number 840015, Greer, South Carolina, 29651, United States|Investigational Site Number 840002, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840046, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840034, Knoxville, Tennessee, 37912, United States|Investigational Site Number 840055, Arlington, Texas, 76014, United States|Investigational Site Number 840001, Dallas, Texas, 75230, United States|Investigational Site Number 840024, Irving, Texas, 75039, United States|Investigational Site Number 840061, North Richland Hills, Texas, 76180, United States|Investigational Site Number 840028, Richmond, Texas, 77469, United States|Investigational Site Number 840063, San Antonio, Texas, 78230, United States|Investigational Site Number 840038, Saint George, Utah, 84790, United States|Investigational Site Number 840025, Federal Way, Washington, 98003, United States|Investigational Site Number 840060, Bridgeport, West Virginia, 26330, United States|Investigational Site Number 032001, Caba, 1120, Argentina|Investigational Site Number 032002, Caba, 1405, Argentina|Investigational Site Number 032006, Capital Federal, 1180, Argentina|Investigational Site Number 032004, Ciudad Autonoma De Buenos Aire, 1206, Argentina|Investigational Site Number 032003, Mar Del Plata, 7602, Argentina|Investigational Site Number 036002, Box Hill, 3128, Australia|Investigational Site Number 036004, Fitzroy, 3065, Australia|Investigational Site Number 036001, Geelong, 3220, Australia|Investigational Site Number 036003, Herston, 4029, Australia|Investigational Site Number 124003, Brampton, L6S 0C9, Canada|Investigational Site Number 124005, Burlington, L7M 4Y1, Canada|Investigational Site Number 124008, Chatham, N7L 1C1, Canada|Investigational Site Number 124010, Mirabel, J7J 2K8, Canada|Investigational Site Number 124009, Montreal, H2X 0A9, Canada|Investigational Site Number 124006, Sainte-Foy, G1W4R4, Canada|Investigational Site Number 124004, Thornhill, L4J 8L7, Canada|Investigational Site Number 124002, Toronto, M4G 3E8, Canada|Investigational Site Number 124001, Vancouver, V5Y 3W2, Canada|Investigational Site Number 124007, Vancouver, V5Z 1L8, Canada|Investigational Site Number 170004, Armenia, 630004, Colombia|Investigational Site Number 170007, Barranquilla, 80020, Colombia|Investigational Site Number 170001, Bogota, 110221, Colombia|Investigational Site Number 170005, Bogota, 111311, Colombia|Investigational Site Number 170003, Manizales, 170004, Colombia|Investigational Site Number 250004, Lyon, 69495, France|Investigational Site Number 250006, Nantes Cedex 01, 44093, France|Investigational Site Number 250005, Poitiers Cedex, 86021, France|Investigational Site Number 276004, Dresden, 01307, Germany|Investigational Site Number 276003, Essen, 45359, Germany|Investigational Site Number 276001, München, 81925, Germany|Investigational Site Number 276005, Potsdam, 14469, Germany|Investigational Site Number 276002, Saarlouis, 66740, Germany|Investigational Site Number 348004, Balatonfüred, 8230, Hungary|Investigational Site Number 348001, Budapest, 1036, Hungary|Investigational Site Number 348005, Budapest, 1062, Hungary|Investigational Site Number 348007, Budapest, 1062, Hungary|Investigational Site Number 348003, Budapest, 1213, Hungary|Investigational Site Number 348008, Csongrád, 6640, Hungary|Investigational Site Number 348009, Debrecen, 4031, Hungary|Investigational Site Number 348002, Gyula, 5700, Hungary|Investigational Site Number 380004, Bologna, 40138, Italy|Investigational Site Number 380005, Chieti, 66013, Italy|Investigational Site Number 380003, Genova, 16132, Italy|Investigational Site Number 380002, Milano, 20122, Italy|Investigational Site Number 380001, Milano, 20132, Italy|Investigational Site Number 392008, Adachi-Ku, Japan|Investigational Site Number 392003, Atsugi-Shi, Japan|Investigational Site Number 392002, Kamakura-Shi, Japan|Investigational Site Number 392010, Sagamihara-Shi, Japan|Investigational Site Number 392004, Sakado-Shi, Japan|Investigational Site Number 392013, Sapporo-Shi, Japan|Investigational Site Number 392012, Sendai-Shi, Japan|Investigational Site Number 410003, Seoul, 110-744, Korea, Republic of|Investigational Site Number 410005, Seoul, 110-746, Korea, Republic of|Investigational Site Number 410002, Seoul, 135-710, Korea, Republic of|Investigational Site Number 410001, Seoul, 136-705, Korea, Republic of|Investigational Site Number 410004, Wonju, 220-701, Korea, Republic of|Investigational Site Number 484002, Aguascalientes, 20230, Mexico|Investigational Site Number 484004, Cuernavaca, 62250, Mexico|Investigational Site Number 484001, Guadalajara, 44150, Mexico|Investigational Site Number 484003, Monterrey, 64460, Mexico|Investigational Site Number 604004, Arequipa, Peru|Investigational Site Number 604007, Ica, 056, Peru|Investigational Site Number 604002, Lima, 27, Peru|Investigational Site Number 604005, Lima, Lima 09, Peru|Investigational Site Number 604001, Lima, LIMA 14, Peru|Investigational Site Number 604006, Lima, Lima 32, Peru|Investigational Site Number 604003, Piura, 20001, Peru|Investigational Site Number 616005, Lublin, 20-538, Poland|Investigational Site Number 616004, Szczecin, 70-506, Poland|Investigational Site Number 616003, Warszawa, 02-507, Poland|Investigational Site Number 616002, Warszawa, 03-242, Poland|Investigational Site Number 616001, Zabrze, 41-800, Poland|Investigational Site Number 642006, Bacau, 600154, Romania|Investigational Site Number 642001, Bucuresti, 020042, Romania|Investigational Site Number 642007, Constanta, 900675, Romania|Investigational Site Number 642004, Oradea, 410159, Romania|Investigational Site Number 642005, Sibiu, 550371, Romania|Investigational Site Number 642002, Targu Mures, 540142, Romania|Investigational Site Number 642003, Targu Mures, 540142, Romania|Investigational Site Number 724004, Alzira, 46600, Spain|Investigational Site Number 724001, Badalona, 08916, Spain|Investigational Site Number 724002, El Ferrol, 15405, Spain|Investigational Site Number 724008, La Coruña, 15006, Spain|Investigational Site Number 724006, Málaga, 29010, Spain|Investigational Site Number 724007, Quart De Poblet, 46930, Spain|Investigational Site Number 724003, Sanlúcar De Barrameda, 11540, Spain|Investigational Site Number 724005, Sevilla, 41071, Spain|Investigational Site Number 752002, Göteborg, 405 45, Sweden|Investigational Site Number 752004, Härnösand, 871 82, Sweden|Investigational Site Number 752003, Rättvik, 79530, Sweden|Investigational Site Number 752001, Västra Frölunda, 421 44, Sweden|Investigational Site Number 826003, Belfast, BT12 6BA, United Kingdom|Investigational Site Number 826005, Belfast, BT16 1RH, United Kingdom|Investigational Site Number 826001, Bristol, BS10 5NB, United Kingdom|Investigational Site Number 826004, Redhill, RH1 5RH, United Kingdom|Investigational Site Number 826006, Rotherham, S60 2UD, United Kingdom|Investigational Site Number 826002, Swansea, SA2 8PP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02320721

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress