Clinical Trial Details
| Trial ID: | L2869 |
| Source ID: | NCT02735044 |
| Associated Drug: | Insulin Glargine,300 U/Ml |
| Title: | Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus |
| Acronym: | EDITION JUNIOR |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02735044/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: Insulin glargine,300 U/mL|DRUG: Insulin glargine (100 units /mL)|DRUG: Background therapy |
| Outcome Measures: | Primary: Change From Baseline in HbA1c to Month 6, Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period., Baseline to Month 6 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6, Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period., Baseline to Month 6|Percentage of Participants With HbA1c Values of <7.5% at Month 6, Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years)., Month 6|Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period, Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years)., upto Month 6|Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6, Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years)., Month 6|Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period, Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years)., upto Month 6|Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6, 8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%), randomization strata of age at screening (\<12 years, \>=12 years) and the baseline 24-hour average 8-point profile SMPG., Baseline to Month 6|Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6, 8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years)., Baseline, Month 6|Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point, 8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime., Baseline to Month 6|Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12, Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration \<=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration \<=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration \>70 mg/dL., Month 12|Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12, Hyperglycemia with ketosis was defined as SMPG \>=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones \>=1.5 mmol/L., Month 12 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 463 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-04-14 |
| Completion Date: | 2018-12-20 |
| Results First Posted: | 2019-06-19 |
| Last Update Posted: | 2022-03-25 |
| Locations: | Investigational Site Number 8400008, Tucson, Arizona, 85724, United States|Investigational Site Number 8400037, Atlanta, Georgia, 30318, United States|Investigational Site Number 8400032, Indianapolis, Indiana, 46202, United States|Investigational Site Number 8400015, Buffalo, New York, 14222, United States|Investigational Site Number 8400016, Chapel Hill, North Carolina, 27599-7295, United States|Investigational Site Number 8400035, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400038, Oklahoma City, Oklahoma, 73112, United States|Investigational Site Number 8400030, Philadelphia, Pennsylvania, 19104, United States|Investigational Site Number 8400010, Rapid City, South Dakota, 57701, United States|Investigational Site Number 8400005, Dallas, Texas, 75231, United States|Investigational Site Number 8400021, Dallas, Texas, 75235, United States|Investigational Site Number 8400029, Lufkin, Texas, 75904, United States|Investigational Site Number 8400034, Seattle, Washington, 98105, United States|Investigational Site Number 0320003, Caba, C1180AAX, Argentina|Investigational Site Number 0320001, Caba, C1270AAN, Argentina|Investigational Site Number 0320004, Capital Federal, C1179AAB, Argentina|Investigational Site Number 0320002, Capital Federal, C1425DUC, Argentina|Investigational Site Number 0320006, Mendoza, 5500, Argentina|Investigational Site Number 0320005, Salta, 4400, Argentina|Investigational Site Number 0320007, San Miguel De Tucuman, 4107, Argentina|Investigational Site Number 0760005, Curitiba, 80810-040, Brazil|Investigational Site Number 0760006, Fortaleza, 60115-282, Brazil|Investigational Site Number 0760004, Fortaleza, 60430-350, Brazil|Investigational Site Number 0760003, Porto Alegre, 91350-250, Brazil|Investigational Site Number 0760001, Sao Paulo, 04022-001, Brazil|Investigational Site Number 0760002, Sao Paulo, Brazil|Investigational Site Number 1000001, Plovdiv, 4000, Bulgaria|Investigational Site Number 1000005, Sofia, 1784, Bulgaria|Investigational Site Number 1000004, Varna, 9000, Bulgaria|Investigational Site Number 1240003, Halifax, B3K6R8, Canada|Investigational Site Number 1240002, Montreal, H1T 2M4, Canada|Investigational Site Number 1240005, Montreal, H3T 1C5, Canada|Investigational Site Number 1240006, Sherbrooke, J1H 5N4, Canada|Investigational Site Number 1520002, Santiago, 8207257, Chile|Investigational Site Number 1520004, Santiago, 8330074, Chile|Investigational Site Number 1520006, Santiago, Chile|Investigational Site Number 1520007, Temuco, 4813299, Chile|Investigational Site Number 1520003, Viña Del Mar, Chile|Investigational Site Number 2030003, Hradec Kralove, 500 05, Czechia|Investigational Site Number 2030005, Ostrava - Poruba, 70852, Czechia|Investigational Site Number 2030001, Praha 5 - Motol, 15006, Czechia|Investigational Site Number 2080001, Herlev, 2730, Denmark|Investigational Site Number 2500003, Montpellier, 34295, France|Investigational Site Number 2500002, Toulouse, 31059, France|Investigational Site Number 2760002, Hannover, 30173, Germany|Investigational Site Number 2760001, Heidelberg, 69120, Germany|Investigational Site Number 2760004, Leipzig, 04103, Germany|Investigational Site Number 2760003, Münster, 48155, Germany|Investigational Site Number 3480001, Budapest, 1036, Hungary|Investigational Site Number 3480004, Budapest, 1083, Hungary|Investigational Site Number 3480003, Budapest, 1089, Hungary|Investigational Site Number 3480005, Gyula, 5700, Hungary|Investigational Site Number 3480002, Miskolc, 3529, Hungary|Investigational Site Number 3480006, Pécs, 7623, Hungary|Investigational Site Number 3480007, Székesfehérvár, 8000, Hungary|Investigational Site Number 3760003, Beer Sheva, 84101, Israel|Investigational Site Number 3760001, Haifa, 31096, Israel|Investigational Site Number 3760006, Holon, 58100, Israel|Investigational Site Number 3760002, Petach Tikva, Israel|Investigational Site Number 3800001, Firenze, 50139, Italy|Investigational Site Number 3800005, Roma, 00165, Italy|Investigational Site Number 3800004, Torino, 10126, Italy|Investigational Site Number 3800006, Varese, 21100, Italy|Investigational Site Number 3800003, Verona, 37134, Italy|Investigational Site Number 3920006, Chiyoda-Ku, Japan|Investigational Site Number 3920002, Fukuoka-Shi, Japan|Investigational Site Number 3920003, Hiroshima-Shi, Japan|Investigational Site Number 3920007, Kobe-Shi, Japan|Investigational Site Number 3920005, Osaka-Shi, Japan|Investigational Site Number 3920004, Shinjuku-Ku, Japan|Investigational Site Number 4280002, Daugavpils, LV-5417, Latvia|Investigational Site Number 4280001, Rīga, LV-1004, Latvia|Investigational Site Number 4840003, Durango, 34000, Mexico|Investigational Site Number 4840001, Monterrey, 64460, Mexico|Investigational Site Number 4840004, México, 06700, Mexico|Investigational Site Number 4840002, Puebla, 72190, Mexico|Investigational Site Number 4840005, Veracruz, 91910, Mexico|Investigational Site Number 8070001, Skopje, 1000, North Macedonia|Investigational Site Number 6160005, Bielsko-Biala, 43-316, Poland|Investigational Site Number 6160001, Gdansk, 80-952, Poland|Investigational Site Number 6160006, Szczecin, 71-252, Poland|Investigational Site Number 6160007, Warszawa, 02-091, Poland|Investigational Site Number 6160004, Warszawa, 04-730, Poland|Investigational Site Number 6160003, Warszawa, 04-736, Poland|Investigational Site Number 6420005, Bucharest, 041451, Romania|Investigational Site Number 6420007, Constanta, 900591, Romania|Investigational Site Number 6420004, Craiova, 200542, Romania|Investigational Site Number 6420006, Sibiu, 550166, Romania|Investigational Site Number 6420003, Timisoara, 300011, Romania|Investigational Site Number 6430001, Moscow, 117036, Russian Federation|Investigational Site Number 6430004, Smolensk, 214018, Russian Federation|Investigational Site Number 6430002, St-Petersburg, 193144, Russian Federation|Investigational Site Number 6430003, Ufa, 450000, Russian Federation|Investigational Site Number 6880002, Belgrade, 11000, Serbia|Investigational Site Number 6880003, Belgrade, 11000, Serbia|Investigational Site Number 6880004, Nis, 18000, Serbia|Investigational Site Number 7240005, Barcelona, 08035, Spain|Investigational Site Number 7240002, Barcelona, 08041, Spain|Investigational Site Number 7240003, Esplugues De Llobregat, 08950, Spain|Investigational Site Number 7240004, Sabadell, 08208, Spain|Investigational Site Number 7240006, Santa Cruz De Tenerife, 38320, Spain|Investigational Site Number 7240001, Vitoria, 01009, Spain|Investigational Site Number 7520002, Stockholm, 118 83, Sweden|Investigational Site Number 8260005, Doncaster, DN2 5LT, United Kingdom|Investigational Site Number 8260001, Ipswich, IP4 5PD, United Kingdom|Investigational Site Number 8260004, Kettering, NN16 8UZ, United Kingdom|Investigational Site Number 8260002, Salisbury, SP2 8BJ, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02735044 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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