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Clinical Trial Details

Trial ID: L7387
Source ID: NCT02738151
Associated Drug: Insulin Glargine, 300u/Ml
Title: Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Acronym: BRIGHT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02738151/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin glargine, 300U/mL|DRUG: Insulin degludec, 100 U/mL|DRUG: Non-insulin anti-diabetic treatment
Outcome Measures: Primary: Change From Baseline in HbA1c to Week 24, Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period., Baseline, Week 24 | Secondary: Change From Baseline in HbA1c to Week 12, Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM., Baseline, Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24, Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period., Baseline, Week 12 and Week 24|Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24, Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period., Baseline, Week 12 and Week 24|Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point, 8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime., Baseline, Week 12 and Week 24|Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point, 4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime., Baseline, Week 12 and Week 24|Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24, The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM., Baseline, Week 12 and Week 24|Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24, Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit., Baseline, Week 12 and Week 24|Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24, Adjusted LS means were obtained from MMRM., Baseline, Week 12 and Week 24|Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24, Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis., Week 12, and Week 24|Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event, Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =\<3.9 mmol/L (=\<70 mg/dL)., Week 12, and Week 24|Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period, Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis., Baseline to Week 24|Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period, Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%., Baseline to Week 24|Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24, Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis., Baseline, Week 12 and Week 24|Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study 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. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Assessment was done by treatment period (for =\<12 weeks, for \>12 weeks to =\<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported., Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study 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. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =\<12 weeks, for \>12 weeks to =\<24 weeks)., Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study 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. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L)., Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study 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. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =\<70 mg/dL (=\<3.9 mmol/L), or \< 54 mg/dL (\<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time)., Day 1-Week 12, Week 13-Week 24, and 24 Week Period | Other: Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24, The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM., Baseline, Week 12 and Week 24
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 929
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-05-19
Completion Date: 2017-08-15
Results First Posted: 2018-09-14
Last Update Posted: 2018-09-14
Locations: Investigational Site Number 840038, Sheffield, Alabama, 35660, United States|Investigational Site Number 840066, Phoenix, Arizona, 85020, United States|Investigational Site Number 840051, Anaheim, California, 92801, United States|Investigational Site Number 840081, Chino, California, 91710, United States|Investigational Site Number 840016, Huntington Park, California, 90255, United States|Investigational Site Number 840002, La Jolla, California, 92037, United States|Investigational Site Number 840091, Los Angeles, California, 90017, United States|Investigational Site Number 840058, Northridge, California, 91324, United States|Investigational Site Number 840021, Palm Springs, California, 92262, United States|Investigational Site Number 840087, Santa Ana, California, 92704, United States|Investigational Site Number 840030, Torrance, California, 90505, United States|Investigational Site Number 840065, Van Nuys, California, 91405, United States|Investigational Site Number 840075, Bradenton, Florida, 34201, United States|Investigational Site Number 840076, New Port Richey, Florida, 34652, United States|Investigational Site Number 840026, Ocoee, Florida, 34761, United States|Investigational Site Number 840052, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840080, Palm Harbor, Florida, 34684, United States|Investigational Site Number 840018, Port Charlotte, Florida, 33952, United States|Investigational Site Number 840071, Lawrenceville, Georgia, 30046, United States|Investigational Site Number 840085, Roswell, Georgia, 30076, United States|Investigational Site Number 840072, Statesboro, Georgia, 30461, United States|Investigational Site Number 840039, Stockbridge, Georgia, 30281, United States|Investigational Site Number 840036, Arlington Heights, Illinois, 60005, United States|Investigational Site Number 840010, Chicago, Illinois, 60616, United States|Investigational Site Number 840005, Avon, Indiana, 46123, United States|Investigational Site Number 840063, Council Bluffs, Iowa, 51501, United States|Investigational Site Number 840098, Des Moines, Iowa, 50134, United States|Investigational Site Number 840101, Des Moines, Iowa, 50314, United States|Investigational Site Number 840096, West Des Moines, Iowa, 50266, United States|Investigational Site Number 840061, Paris, Kentucky, 40361, United States|Investigational Site Number 840011, Hyattsville, Maryland, 20782, United States|Investigational Site Number 840001, Rockville, Maryland, 20852, United States|Investigational Site Number 840041, Flint, Michigan, 48504, United States|Investigational Site Number 840057, Flint, Michigan, 48532, United States|Investigational Site Number 840033, Troy, Michigan, 48085, United States|Investigational Site Number 840084, Olive Branch, Mississippi, 38654, United States|Investigational Site Number 840048, Chesterfield, Missouri, 63017, United States|Investigational Site Number 840023, Las Vegas, Nevada, 89117, United States|Investigational Site Number 840045, Las Vegas, Nevada, 89128, United States|Investigational Site Number 840031, Linden, New Jersey, 07036, United States|Investigational Site Number 840060, Hickory, North Carolina, 28601, United States|Investigational Site Number 840064, Morganton, North Carolina, 28655, United States|Investigational Site Number 840043, Wilmington, North Carolina, 28401, United States|Investigational Site Number 840082, Winston-Salem, North Carolina, 27103, United States|Investigational Site Number 840025, Oklahoma City, Oklahoma, 73104, United States|Investigational Site Number 840022, Oklahoma City, Oklahoma, 73112, United States|Investigational Site Number 840029, Beaver, Pennsylvania, 15009, United States|Investigational Site Number 840056, Downingtown, Pennsylvania, 19335, United States|Investigational Site Number 840093, Anderson, South Carolina, 29621, United States|Investigational Site Number 840097, Greenville, South Carolina, 29605, United States|Investigational Site Number 840070, Greer, South Carolina, 29651, United States|Investigational Site Number 840044, North Myrtle Beach, South Carolina, 29582, United States|Investigational Site Number 840069, Simpsonville, South Carolina, 29681, United States|Investigational Site Number 840079, Bristol, Tennessee, United States|Investigational Site Number 840006, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840088, Knoxville, Tennessee, 37912, United States|Investigational Site Number 840077, New Tazewell, Tennessee, 37825, United States|Investigational Site Number 840007, Dallas, Texas, 75230, United States|Investigational Site Number 840086, Dallas, Texas, 75231, United States|Investigational Site Number 840027, Houston, Texas, 77061, United States|Investigational Site Number 840004, Houston, Texas, 77083-4436, United States|Investigational Site Number 840040, Houston, Texas, 77090, United States|Investigational Site Number 840046, Houston, Texas, 77095, United States|Investigational Site Number 840054, Hurst, Texas, 76054, United States|Investigational Site Number 840017, Mesquite, Texas, 75149, United States|Investigational Site Number 840008, Missouri City, Texas, 77459, United States|Investigational Site Number 840094, San Antonio, Texas, 78229-3907, United States|Investigational Site Number 840009, Sugar Land, Texas, 77478, United States|Investigational Site Number 840053, Waco, Texas, 76710, United States|Investigational Site Number 840095, Ogden, Utah, 84405, United States|Investigational Site Number 840032, Salt Lake City, Utah, 84102, United States|Investigational Site Number 840024, Norfolk, Virginia, United States|Investigational Site Number 840020, Richmond, Virginia, 23219, United States|Investigational Site Number 840012, Renton, Washington, 98055, United States|Investigational Site Number 100001, Sofia, 1431, Bulgaria|Investigational Site Number 100002, Sofia, 1505, Bulgaria|Investigational Site Number 100003, Sofia, Bulgaria|Investigational Site Number 191001, Rijeka, 51000, Croatia|Investigational Site Number 191002, Rijeka, 51000, Croatia|Investigational Site Number 191003, Zagreb, Croatia|Investigational Site Number 203009, Hlucin, Czechia|Investigational Site Number 203006, Jilove u Prahy, 25401, Czechia|Investigational Site Number 203005, Liberec, 46001, Czechia|Investigational Site Number 203001, Pardubice, 53002, Czechia|Investigational Site Number 203007, Praha 1, 11000, Czechia|Investigational Site Number 203008, Praha 2, 12808, Czechia|Investigational Site Number 203002, Praha 8, 18100, Czechia|Investigational Site Number 203004, Vsetin, 75501, Czechia|Investigational Site Number 208003, Aarhus, 8000, Denmark|Investigational Site Number 208002, Hillerød, 3400, Denmark|Investigational Site Number 208001, København NV., 2400, Denmark|Investigational Site Number 208004, Odense, 5000, Denmark|Investigational Site Number 250002, La Roche Sur Yon, 85025, France|Investigational Site Number 250003, La Rochelle Cedex 1, 17019, France|Investigational Site Number 250001, Nantes cedex 01, 44093, France|Investigational Site Number 250006, Nimes, 30029, France|Investigational Site Number 250005, POITIERS Cedex, 86021, France|Investigational Site Number 250007, Venissieux, 69200, France|Investigational Site Number 300005, Alexandroupolis, 68100, Greece|Investigational Site Number 300001, Athens, 17562, Greece|Investigational Site Number 300002, Athens, Greece|Investigational Site Number 300003, Athens, Greece|Investigational Site Number 348004, Budapest, 1042, Hungary|Investigational Site Number 348002, Budapest, 1083, Hungary|Investigational Site Number 348001, Budapest, 1106, Hungary|Investigational Site Number 348003, Gyöngyös, 3200, Hungary|Investigational Site Number 376001, Haifa, 31096, Israel|Investigational Site Number 376004, Haifa, Israel|Investigational Site Number 376008, Haifa, Israel|Investigational Site Number 376009, Kfar Saba, Israel|Investigational Site Number 376002, Petach tikva, Israel|Investigational Site Number 376006, Tel Aviv, Israel|Investigational Site Number 376003, Tel Hashomer, 52621, Israel|Investigational Site Number 376007, Tel-Aviv, Israel|Investigational Site Number 380007, Bari, 70124, Italy|Investigational Site Number 380009, Catanzaro, Italy|Investigational Site Number 380010, Chieti, 66013, Italy|Investigational Site Number 380014, Milano, 20132, Italy|Investigational Site Number 380002, Moncalieri, 10024, Italy|Investigational Site Number 380011, Napoli, 80131, Italy|Investigational Site Number 380008, Roma, Italy|Investigational Site Number 380015, Roma, Italy|Investigational Site Number 380016, Roma, Italy|Investigational Site Number 380013, Sesto San Giovanni, 20099, Italy|Investigational Site Number 380005, Torino, 10126, Italy|Investigational Site Number 380012, Verona, 37126, Italy|Investigational Site Number 642007, Brasov, 500097, Romania|Investigational Site Number 642008, Brasov, 500326, Romania|Investigational Site Number 642001, Bucharest, 022441, Romania|Investigational Site Number 642013, Bucharest, 040172, Romania|Investigational Site Number 642015, Bucuresti, Romania|Investigational Site Number 642003, Cluj-Napoca, 400006, Romania|Investigational Site Number 642009, Constanta, 900675, Romania|Investigational Site Number 642014, Iasi, 700547, Romania|Investigational Site Number 642005, Oradea, Romania|Investigational Site Number 642012, Oradea, Romania|Investigational Site Number 642010, Targu-Mures, 540015, Romania|Investigational Site Number 642004, Targu-Mures, 540142, Romania|Investigational Site Number 642006, Targu-Mures, Romania|Investigational Site Number 688001, Belgrade, 11000, Serbia|Investigational Site Number 688002, Nis, Serbia|Investigational Site Number 688003, Nis, Serbia|Investigational Site Number 703006, Kosice, 04013, Slovakia|Investigational Site Number 703002, Lubochna, 03491, Slovakia|Investigational Site Number 703001, Moldava nad Bodvou, 04525, Slovakia|Investigational Site Number 703003, Sabinov, 08301, Slovakia|Investigational Site Number 703005, Trebisov, 07501, Slovakia|Investigational Site Number 752102, Lund, 22241, Sweden|Investigational Site Number 752101, Skövde, 54150, Sweden|Investigational Site Number 756003, Olten, 4600, Switzerland|Investigational Site Number 756001, St. Gallen, 9016, Switzerland|Investigational Site Number 826001, Chertsey, KT160PZ, United Kingdom|Investigational Site Number 826005, Gillingham, ME75NY, United Kingdom|Investigational Site Number 826008, Lincoln, LN25QY, United Kingdom|Investigational Site Number 826002, London, SW109NH, United Kingdom|Investigational Site Number 826009, Manchester, M415SL, United Kingdom|Investigational Site Number 826006, Margate, CT94ANA, United Kingdom|Investigational Site Number 826004, Swansea, SA66NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02738151

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress