Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5504
Source ID: NCT01768559
Associated Drug: Lixisenatide (Ave0010)
Title: Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Acronym: GetGoal-Duo-2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01768559/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Lixisenatide (AVE0010)|DRUG: Insulin glulisine QD|DRUG: Insulin glulisine TID|DRUG: Insulin Glargine (Mandatory background drug)|DRUG: Metformin (Background drug)
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period., Baseline, Week 26|Change in Body Weight From Baseline to Week 26, Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug., Baseline, Week 26 | Secondary: Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26, The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF., Week 26|Percentage of Participants With no Weight Gain at Week 26, The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug., Week 26|Change in Average 7-point SMPG Profiles From Baseline to Week 26, Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug., Baseline, Week 26|Change in FPG From Baseline to Week 26, Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug., Baseline, Week 26|Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast), The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug., Baseline, Week 26|Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast), Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug., Baseline, Week 26|Change in Insulin Glargine Dose From Baseline to Week 26, Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug., Baseline, Week 26|Insulin Glulisine Dose at Week 26, The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF., Week 26|Total Insulin Dose at Week 26, The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9., Week 26|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia, Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available., First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period, The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug., Week 26|Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26, The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug., Week 26|Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period, The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data., Week 26
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 894
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-01
Completion Date: 2014-12
Results First Posted: 2017-01-04
Last Update Posted: 2017-01-04
Locations: Investigational Site Number 840043, Sun City, Arizona, 85351, United States|Investigational Site Number 840042, Tempe, Arizona, 85282, United States|Investigational Site Number 840003, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840031, La Mesa, California, 91942, United States|Investigational Site Number 840005, Mission Viejo, California, 92691, United States|Investigational Site Number 840057, Northridge, California, 91325, United States|Investigational Site Number 840035, Santa Ana, California, 92704, United States|Investigational Site Number 840002, Temecula, California, 92591, United States|Investigational Site Number 840037, Walnut Creek, California, 94598, United States|Investigational Site Number 840023, West Hills, California, 91345, United States|Investigational Site Number 840041, Denver, Colorado, 80246, United States|Investigational Site Number 840012, Miami, Florida, 33136, United States|Investigational Site Number 840061, Miami, Florida, 33142, United States|Investigational Site Number 840045, Lawrenceville, Georgia, 30045, United States|Investigational Site Number 840036, Nampa, Idaho, 83686, United States|Investigational Site Number 840024, Chicago, Illinois, 60611, United States|Investigational Site Number 840009, Evanston, Illinois, 60201, United States|Investigational Site Number 840004, Avon, Indiana, 46123, United States|Investigational Site Number 840055, Avon, Indiana, 46123, United States|Investigational Site Number 840027, Des Moines, Iowa, 50314, United States|Investigational Site Number 840006, Wichita, Kansas, 67203, United States|Investigational Site Number 840047, Lexington, Kentucky, 40504, United States|Investigational Site Number 840056, Paducah, Kentucky, 42003, United States|Investigational Site Number 840022, Marrero, Louisiana, 70072, United States|Investigational Site Number 840016, Baltimore, Maryland, 21237, United States|Investigational Site Number 840017, Rockville, Maryland, 20852, United States|Investigational Site Number 840025, Buckley, Michigan, 49620, United States|Investigational Site Number 840048, Dearborn, Michigan, 48124, United States|Investigational Site Number 840026, Kalamazoo, Michigan, 49048, United States|Investigational Site Number 840049, Las Vegas, Nevada, 89148, United States|Investigational Site Number 840029, New Hyde Park, New York, 11042, United States|Investigational Site Number 840060, Smithtown, New York, 11787, United States|Investigational Site Number 840030, Staten Island, New York, 10301-3914, United States|Investigational Site Number 840011, Salisbury, North Carolina, 28144, United States|Investigational Site Number 840028, Fargo, North Dakota, 58103, United States|Investigational Site Number 840007, Oklahoma City, Oklahoma, 73104, United States|Investigational Site Number 840021, Pittsburgh, Pennsylvania, 15212, United States|Investigational Site Number 840052, Myrtle Beach, South Carolina, 29572, United States|Investigational Site Number 840032, Chattanooga, Tennessee, 37404, United States|Investigational Site Number 840033, Nashville, Tennessee, 37232, United States|Investigational Site Number 840034, Corpus Christi, Texas, 78404, United States|Investigational Site Number 840001, Dallas, Texas, 75230, United States|Investigational Site Number 840020, Houston, Texas, 77081, United States|Investigational Site Number 840018, Norfolk, Virginia, 23502, United States|Investigational Site Number 840015, Salem, Virginia, 24153, United States|Investigational Site Number 840010, Milwaukee, Wisconsin, 53217, United States|Investigational Site Number 124008, Brampton, L6R 3J5, Canada|Investigational Site Number 124015, Burlington, L7M 4Y1, Canada|Investigational Site Number 124018, Chatham, N7L 1C1, Canada|Investigational Site Number 124004, Coquitlam, V3K 3P4, Canada|Investigational Site Number 124016, Etobicoke, M9R 4E1, Canada|Investigational Site Number 124014, Hamilton, L8L 5G8, Canada|Investigational Site Number 124020, Montreal, H1Y 3L1, Canada|Investigational Site Number 124011, Montreal, H3A 1A1, Canada|Investigational Site Number 124017, Newmarket, L3Y 5G8, Canada|Investigational Site Number 124021, Quebec, G1N 4V3, Canada|Investigational Site Number 124003, Red Deer, T4N 6V7, Canada|Investigational Site Number 124002, Sherbrooke, J1H 5N4, Canada|Investigational Site Number 124012, St-Romuald, G6W 5M6, Canada|Investigational Site Number 124001, Toronto, M4G 3E8, Canada|Investigational Site Number 124010, Toronto, M5C 2T2, Canada|Investigational Site Number 124005, Vancouver, V5Z 1M9, Canada|Investigational Site Number 124006, Victoria, V8V 4A1, Canada|Investigational Site Number 124007, Winnipeg, R3E 3P4, Canada|Investigational Site Number 152103, Santiago, 7500010, Chile|Investigational Site Number 152107, Santiago, 7500347, Chile|Investigational Site Number 152101, Santiago, 7500710, Chile|Investigational Site Number 152105, Santiago, 7591047, Chile|Investigational Site Number 152102, Santiago, 7980378, Chile|Investigational Site Number 152106, Santiago, 8053095, Chile|Investigational Site Number 152108, Santiago, 8053095, Chile|Investigational Site Number 152109, Santiago, Chile|Investigational Site Number 203107, Beroun, 26601, Czech Republic|Investigational Site Number 203103, Jilove U Prahy, 254 01, Czech Republic|Investigational Site Number 203101, Ostrava 2, 702 00, Czech Republic|Investigational Site Number 203110, Police Nad Metuji, 549 54, Czech Republic|Investigational Site Number 203105, Praha 4, 14021, Czech Republic|Investigational Site Number 203102, Praha 4, 148 00, Czech Republic|Investigational Site Number 203108, Praha 4, 14900, Czech Republic|Investigational Site Number 203104, Trutnov, 54101, Czech Republic|Investigational Site Number 233102, Pärnu, 80018, Estonia|Investigational Site Number 233103, Tallinn, 13415, Estonia|Investigational Site Number 233104, Tallinn, 13419, Estonia|Investigational Site Number 233101, Viljandimaa, 71024, Estonia|Investigational Site Number 250108, Bois Guillaume, 76230, France|Investigational Site Number 250105, Corbeil Essonnes, 91100, France|Investigational Site Number 250104, La Rochelle Cedex, 17019, France|Investigational Site Number 250106, Lyon, 69495, France|Investigational Site Number 250107, Lyon, 69495, France|Investigational Site Number 250109, Mantes La Jolie, 78200, France|Investigational Site Number 250102, Paris Cedex 15, 75908, France|Investigational Site Number 250101, Vandoeuvre Les Nancy, 54511, France|Investigational Site Number 250103, Venissieux, 69200, France|Investigational Site Number 276112, Bad Mergentheim, 97980, Germany|Investigational Site Number 276108, Berlin, 13125, Germany|Investigational Site Number 276102, Dortmund, 44137, Germany|Investigational Site Number 276120, Dresden, 01067, Germany|Investigational Site Number 276106, Dresden, 01307, Germany|Investigational Site Number 276117, Frankfurt A.M., 60596, Germany|Investigational Site Number 276116, Görlitz, 02826, Germany|Investigational Site Number 276113, Heidelberg, 69115, Germany|Investigational Site Number 276118, Leipzig, 04103, Germany|Investigational Site Number 276119, Magdeburg, 39104, Germany|Investigational Site Number 276103, Neumünster, 24534, Germany|Investigational Site Number 276115, Speyer, 67346, Germany|Investigational Site Number 276109, St. Ingbert-Oberwürzbach, 66386, Germany|Investigational Site Number 348107, Budapest, 1134, Hungary|Investigational Site Number 348108, Budapest, 1138, Hungary|Investigational Site Number 348102, Budapest, 1139, Hungary|Investigational Site Number 348101, Eger, 3300, Hungary|Investigational Site Number 348103, Pápa, 8500, Hungary|Investigational Site Number 348104, Szeged, 6720, Hungary|Investigational Site Number 348106, Sátoraljaújhely, 3980, Hungary|Investigational Site Number 348105, Zalaegerszeg, 8900, Hungary|Investigational Site Number 380103, Bologna, 40138, Italy|Investigational Site Number 380102, Catania, 95122, Italy|Investigational Site Number 380101, Milano, 20132, Italy|Investigational Site Number 380105, Napoli, 80131, Italy|Investigational Site Number 380104, Torino, 10126, Italy|Investigational Site Number 428103, Jelgava, LV-3001, Latvia|Investigational Site Number 428104, Ogre, LV-5001, Latvia|Investigational Site Number 428102, Riga, LV-1002, Latvia|Investigational Site Number 428105, Riga, LV-1006, Latvia|Investigational Site Number 428101, Sigulda, LV-2150, Latvia|Investigational Site Number 440104, Jonava, LT-55201, Lithuania|Investigational Site Number 440103, Kaunas, LT-48259, Lithuania|Investigational Site Number 440102, Kaunas, LT-49456, Lithuania|Investigational Site Number 440101, Kaunas, LT-51270, Lithuania|Investigational Site Number 440105, Klaipeda, LT-92288, Lithuania|Investigational Site Number 484108, Chihuahua, 31200, Mexico|Investigational Site Number 484101, Cuernavaca, 62250, Mexico|Investigational Site Number 484111, Durango, 34080, Mexico|Investigational Site Number 484104, Guadalajara, 44150, Mexico|Investigational Site Number 484109, Guadalajara, 44210, Mexico|Investigational Site Number 484107, Guadalajara, 44600, Mexico|Investigational Site Number 484105, Guadalajara, 44650, Mexico|Investigational Site Number 484110, Guadalajara, 44656, Mexico|Investigational Site Number 484103, Mexico Df, 11850, Mexico|Investigational Site Number 484106, Monterrey, 64000, Mexico|Investigational Site Number 484102, México, 06700, Mexico|Investigational Site Number 616101, Bialystok, 15-435, Poland|Investigational Site Number 616103, Bydgoszcz, 85-822, Poland|Investigational Site Number 616102, Bytom, 41-902, Poland|Investigational Site Number 616106, Krakow, 31-455, Poland|Investigational Site Number 616104, Krakow, 31-548, Poland|Investigational Site Number 616105, Pulawy, 24-100, Poland|Investigational Site Number 616107, Warszawa, 02-507, Poland|Investigational Site Number 642105, Bacau, 600114, Romania|Investigational Site Number 642108, Cluj Napoca, 400006, Romania|Investigational Site Number 642106, Deva, 330084, Romania|Investigational Site Number 642113, Galati, 800098, Romania|Investigational Site Number 642107, Hunedoara, 331057, Romania|Investigational Site Number 642117, Iasi, 700547, Romania|Investigational Site Number 642103, Oradea, 410169, Romania|Investigational Site Number 642104, Oradea, 410169, Romania|Investigational Site Number 642112, Pitesti, 110084, Romania|Investigational Site Number 642114, Ploiesti, 100342, Romania|Investigational Site Number 642102, Resita, 320076, Romania|Investigational Site Number 642111, Sibiu, 550371, Romania|Investigational Site Number 642109, Targu Mures, 540142, Romania|Investigational Site Number 642110, Targu Mures, 540142, Romania|Investigational Site Number 642116, Timisoara, 300133, Romania|Investigational Site Number 642101, Timisoara, 300456, Romania|Investigational Site Number 642115, Timisoara, 300723, Romania|Investigational Site Number 643111, Moscow, 117036, Russian Federation|Investigational Site Number 643107, Moscow, 119991, Russian Federation|Investigational Site Number 643105, Moscow, 129110, Russian Federation|Investigational Site Number 643110, Penza, 440026, Russian Federation|Investigational Site Number 643102, Saratov, 410030, Russian Federation|Investigational Site Number 643101, St-Petersburg, 194044, Russian Federation|Investigational Site Number 643104, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643109, St-Petersburg, 194354, Russian Federation|Investigational Site Number 643108, St-Petersburg, 195112, Russian Federation|Investigational Site Number 643103, St-Petersburg, 195257, Russian Federation|Investigational Site Number 643106, St. Petersburg, 194358, Russian Federation|Investigational Site Number 724102, El Ferrol, 15403, Spain|Investigational Site Number 724105, La Coruña, 15006, Spain|Investigational Site Number 724103, Malaga, 29010, Spain|Investigational Site Number 724104, Sevilla, 41010, Spain|Investigational Site Number 804104, Chernivtsi, 58022, Ukraine|Investigational Site Number 804107, Donetsk, 83003, Ukraine|Investigational Site Number 804103, Donetsk, 83059, Ukraine|Investigational Site Number 804108, Mykolaiv, 54003, Ukraine|Investigational Site Number 804110, Odessa, 65059, Ukraine|Investigational Site Number 804105, Vinnytsya, 21001, Ukraine|Investigational Site Number 804102, Vinnytsya, 21010, Ukraine|Investigational Site Number 804111, Zaporizhia, 69600, Ukraine|Investigational Site Number 826006, Ashton-Under-Lyne, OL6 9RW, United Kingdom|Investigational Site Number 826002, Birmingham, B9 5SS, United Kingdom|Investigational Site Number 826007, Carmarthen, SA31 2AF, United Kingdom|Investigational Site Number 826005, Chester, CH2 1UL, United Kingdom|Investigational Site Number 826008, Coventry, CV1 4FH, United Kingdom|Investigational Site Number 826009, Dundee, DD1 9SI, United Kingdom|Investigational Site Number 826001, Durham, DH1 5TW, United Kingdom|Investigational Site Number 826011, Haddington, EH41 3PF, United Kingdom|Investigational Site Number 826012, Leicester, LE5 4PW, United Kingdom|Investigational Site Number 826010, Plymouth, PL6 8BX, United Kingdom|Investigational Site Number 826004, Sheffield, S5 7AU, United Kingdom|Investigational Site Number 826003, St Helens, WA93DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01768559

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details