CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L2286
Source ID:	NCT02294474
Associated Drug:	Sar342434
Title:	Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Acronym:	SORELLA2
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT02294474/results
Conditions:	Type 2 Diabetes Mellitus
Interventions:	DRUG: SAR342434\|DRUG: Humalog\|DRUG: insulin glargine HOE901
Outcome Measures:	Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square 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 6-month period and adequate contrasts at Week 26., Baseline, Week 26 \| Secondary: Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26, Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders., Week 26\|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26., Baseline, Week 26\|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26, The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26., Baseline, Week 26\|Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26, Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26., Baseline, Week 26\|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia), Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day were reported. 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 symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (\<3.0 mmol/L) were also analyzed., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)\|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions, Percentage of participants with hypersensitivity reactions and injection site reactions were reported., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)\|Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs), Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA)., First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days) \| Other: Change in Daily Insulin Dose From Baseline to Week 26, Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value., Baseline, Week 26
Sponsor/Collaborators:	Sponsor: Sanofi
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	505
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date:	2015-01
Completion Date:	2016-02
Results First Posted:	2018-01-18
Last Update Posted:	2018-01-18
Locations:	Investigational Site Number 840217, Foley, Alabama, 36535, United States\|Investigational Site Number 840237, Muscle Shoals, Alabama, 35661, United States\|Investigational Site Number 840245, Chandler, Arizona, United States\|Investigational Site Number 840219, Phoenix, Arizona, 85028, United States\|Investigational Site Number 840227, Phoenix, Arizona, 85050, United States\|Investigational Site Number 840212, Little Rock, Arkansas, 72205, United States\|Investigational Site Number 840241, El Cajon, California, 92020, United States\|Investigational Site Number 840238, Fresno, California, 93720, United States\|Investigational Site Number 840229, Greenbrae, California, 94904, United States\|Investigational Site Number 840231, Huntington Beach, California, 92648, United States\|Investigational Site Number 840247, Long Beach, California, 90807, United States\|Investigational Site Number 840234, Los Angeles, California, 90057, United States\|Investigational Site Number 840235, Northridge, California, 91325, United States\|Investigational Site Number 840251, Palm Springs, California, 92262, United States\|Investigational Site Number 840249, Santa Ana, California, 92704, United States\|Investigational Site Number 840223, Temecula, California, 92591, United States\|Investigational Site Number 840259, Tustin, California, 92780, United States\|Investigational Site Number 840240, Walnut Creek, California, 94598, United States\|Investigational Site Number 840214, Boynton Beach, Florida, 33472, United States\|Investigational Site Number 840246, Miami, Florida, 33176, United States\|Investigational Site Number 840226, New Port Richey, Florida, 34652, United States\|Investigational Site Number 840205, Ocoee, Florida, 34761, United States\|Investigational Site Number 840206, Palm Harbor, Florida, 34684, United States\|Investigational Site Number 840242, Port Charlotte, Florida, 33952, United States\|Investigational Site Number 840253, Lawrenceville, Georgia, 30046, United States\|Investigational Site Number 840207, Stockbridge, Georgia, 30281, United States\|Investigational Site Number 840248, Arlington Heights, Illinois, 60005, United States\|Investigational Site Number 840204, Avon, Indiana, 46123, United States\|Investigational Site Number 840257, Evansville, Indiana, 47714, United States\|Investigational Site Number 840230, Des Moines, Iowa, 50314, United States\|Investigational Site Number 840239, Rockville, Maryland, 20852, United States\|Investigational Site Number 840236, Troy, Michigan, 48085, United States\|Investigational Site Number 840216, Lincoln, Nebraska, 68521, United States\|Investigational Site Number 840220, Las Vegas, Nevada, 89119, United States\|Investigational Site Number 840233, Las Vegas, Nevada, 89148, United States\|Investigational Site Number 840224, Linden, New Jersey, United States\|Investigational Site Number 840232, Greensboro, North Carolina, 27408, United States\|Investigational Site Number 840211, Morehead City, North Carolina, 28557, United States\|Investigational Site Number 840228, Morganton, North Carolina, 28655, United States\|Investigational Site Number 840225, Fargo, North Dakota, 58103, United States\|Investigational Site Number 840221, Columbus, Ohio, 43201, United States\|Investigational Site Number 840255, Dayton, Ohio, 45439, United States\|Investigational Site Number 840250, Tipton, Pennsylvania, 16684, United States\|Investigational Site Number 840243, Uniontown, Pennsylvania, 15401, United States\|Investigational Site Number 840208, Chattanooga, Tennessee, 37404, United States\|Investigational Site Number 840215, Jackson, Tennessee, 38305, United States\|Investigational Site Number 840203, Austin, Texas, 78731, United States\|Investigational Site Number 840258, Dallas, Texas, 75231, United States\|Investigational Site Number 840201, Dallas, Texas, 75246, United States\|Investigational Site Number 840222, Renton, Washington, 98055, United States\|Investigational Site Number 840209, Milwaukee, Wisconsin, 53209-0996, United States\|Investigational Site Number 032201, Caba, C1425AGC, Argentina\|Investigational Site Number 032206, Capital Federal, C1056ABJ, Argentina\|Investigational Site Number 032202, Capital Federal, C1179AAB, Argentina\|Investigational Site Number 032205, Ciudad Autonoma De Buenos Aire, Argentina\|Investigational Site Number 032203, Salta, 4400, Argentina\|Investigational Site Number 152202, Santiago, 7500347, Chile\|Investigational Site Number 152204, Santiago, 7500347, Chile\|Investigational Site Number 152201, Santiago, 7500710, Chile\|Investigational Site Number 170203, Armenia, 630004, Colombia\|Investigational Site Number 276201, Berlin, 10115, Germany\|Investigational Site Number 276204, Heidelberg, 69115, Germany\|Investigational Site Number 276202, Neumünster, 24534, Germany\|Investigational Site Number 276206, Potsdam, 14469, Germany\|Investigational Site Number 276205, Stuttgart, 70378, Germany\|Investigational Site Number 276203, Sulzbach-Rosenberg, 92237, Germany\|Investigational Site Number 348205, Budapest, 1036, Hungary\|Investigational Site Number 348202, Budapest, 1135, Hungary\|Investigational Site Number 348204, Debrecen, 4032, Hungary\|Investigational Site Number 348208, Komárom, 2900, Hungary\|Investigational Site Number 348210, Nagykanizsa, 8800, Hungary\|Investigational Site Number 348203, Szolnok, 5004, Hungary\|Investigational Site Number 348209, Sátoraljaújhely, 3980, Hungary\|Investigational Site Number 380203, Bologna, 40138, Italy\|Investigational Site Number 380201, Milano, 20132, Italy\|Investigational Site Number 380204, Roma, 00133, Italy\|Investigational Site Number 380202, Sesto San Giovanni, 20099, Italy\|Investigational Site Number 410202, Seoul, 110-746, Korea, Republic of\|Investigational Site Number 410204, Seoul, 130-872, Korea, Republic of\|Investigational Site Number 410205, Seoul, 139-872, Korea, Republic of\|Investigational Site Number 410201, Wonju, 220-701, Korea, Republic of\|Investigational Site Number 642210, Bacau, 600154, Romania\|Investigational Site Number 642201, Bucuresti, 020042, Romania\|Investigational Site Number 642202, Bucuresti, 020042, Romania\|Investigational Site Number 642206, Cluj Napoca, 400006, Romania\|Investigational Site Number 642204, Deva, 330084, Romania\|Investigational Site Number 642205, Oradea, 410159, Romania\|Investigational Site Number 642209, Sibiu, 550371, Romania\|Investigational Site Number 642207, Targu Mures, 540142, Romania\|Investigational Site Number 642208, Targu Mures, 540142, Romania\|Investigational Site Number 642203, Timisoara, 300456, Romania\|Investigational Site Number 643201, Saint-Petersburg, 190013, Russian Federation\|Investigational Site Number 643205, Saratov, 410030, Russian Federation\|Investigational Site Number 643203, St-Petersburg, 194354, Russian Federation\|Investigational Site Number 643202, St-Petersburg, 195257, Russian Federation\|Investigational Site Number 643204, St. Petersburg, 194358, Russian Federation\|Investigational Site Number 724201, Barcelona, 08035, Spain\|Investigational Site Number 724203, Málaga, 29010, Spain\|Investigational Site Number 724202, Palma De Mallorca, 07010, Spain\|Investigational Site Number 792201, Istanbul, 34303, Turkey\|Investigational Site Number 792202, Istanbul, 34890, Turkey\|Investigational Site Number 792204, Izmir, 35100, Turkey\|Investigational Site Number 792203, Izmir, 35340, Turkey
URL:	https://clinicaltrials.gov/show/NCT02294474

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)