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Clinical Trial Details

Trial ID: L6177
Source ID: NCT00763815
Associated Drug: Lixisenatide (Ave0010)
Title: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
Acronym: GETGOAL-P
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00763815/results
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: Lixisenatide (AVE0010)|DRUG: Placebo|DEVICE: Pen auto-injector|DRUG: Pioglitazone|DRUG: Metformin
Outcome Measures: Primary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24, Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24|Change From Baseline in Body Weight at Week 24, Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24, Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24, The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Week 24|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24, The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Week 24|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24, Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin \[micro unit per milliliter\]) divided by (fasting plasma glucose \[mmol/L\] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period, Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline up to Week 24 | Other: Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24, The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required., Baseline, Week 24|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia, Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient 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, for up to 132 weeks
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 484
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-09
Completion Date: 2011-06
Results First Posted: 2016-10-11
Last Update Posted: 2016-11-28
Locations: Sanofi-Aventis Investigational Site Number 840723, Birmingham, Alabama, 35205, United States|Sanofi-Aventis Investigational Site Number 840744, Birmingham, Alabama, 35205, United States|Sanofi-Aventis Investigational Site Number 840867, Birmingham, Alabama, 35235, United States|Sanofi-Aventis Investigational Site Number 840720, Birmingham, Alabama, 35242, United States|Sanofi-Aventis Investigational Site Number 840855, Mobile, Alabama, 36608, United States|Sanofi-Aventis Investigational Site Number 840863, Mobile, Alabama, 36608, United States|Sanofi-Aventis Investigational Site Number 840775, Chandler, Arizona, 85224, United States|Sanofi-Aventis Investigational Site Number 840722, Mesa, Arizona, 85213, United States|Sanofi-Aventis Investigational Site Number 840769, Phoenix, Arizona, 85050, United States|Sanofi-Aventis Investigational Site Number 840729, Harrisburg, Arkansas, 72432, United States|Sanofi-Aventis Investigational Site Number 840776, Mountain Home, Arkansas, 72653, United States|Sanofi-Aventis Investigational Site Number 840795, Artesia, California, 90701, United States|Sanofi-Aventis Investigational Site Number 840782, Chino, California, 91710, United States|Sanofi-Aventis Investigational Site Number 840785, Huntington Beach, California, 92648, United States|Sanofi-Aventis Investigational Site Number 840858, La Jolla, California, 92037, United States|Sanofi-Aventis Investigational Site Number 840784, Los Banos, California, 93635, United States|Sanofi-Aventis Investigational Site Number 840773, Mission Hills, California, 91345, United States|Sanofi-Aventis Investigational Site Number 840707, Mission Viejo, California, 92691, United States|Sanofi-Aventis Investigational Site Number 840733, Northridge, California, 91325, United States|Sanofi-Aventis Investigational Site Number 840864, Roseville, California, 95661, United States|Sanofi-Aventis Investigational Site Number 840772, San Diego, California, 92123, United States|Sanofi-Aventis Investigational Site Number 840743, San Mateo, California, 94401, United States|Sanofi-Aventis Investigational Site Number 840721, Stockton, California, 95204, United States|Sanofi-Aventis Investigational Site Number 840763, West Hills, California, 91307, United States|Sanofi-Aventis Investigational Site Number 840872, Colorado Springs, Colorado, 80907, United States|Sanofi-Aventis Investigational Site Number 840868, Colorado Springs, Colorado, 80909, United States|Sanofi-Aventis Investigational Site Number 840727, Jacksonville, Florida, 32216, United States|Sanofi-Aventis Investigational Site Number 840745, New Port Richey, Florida, 34652, United States|Sanofi-Aventis Investigational Site Number 840761, Oviedo, Florida, 32765, United States|Sanofi-Aventis Investigational Site Number 840799, Wellington, Florida, 33414, United States|Sanofi-Aventis Investigational Site Number 840857, Augusta, Georgia, 30909, United States|Sanofi-Aventis Investigational Site Number 840724, Idaho Falls, Idaho, 83404, United States|Sanofi-Aventis Investigational Site Number 840791, Chicago, Illinois, 60611, United States|Sanofi-Aventis Investigational Site Number 840738, Avon, Indiana, 46123, United States|Sanofi-Aventis Investigational Site Number 840794, Indianapolis, Indiana, 46260, United States|Sanofi-Aventis Investigational Site Number 840767, Kansas City, Kansas, 66160-7321, United States|Sanofi-Aventis Investigational Site Number 840779, Lansing, Kansas, 66043, United States|Sanofi-Aventis Investigational Site Number 840739, Wichita, Kansas, 67203, United States|Sanofi-Aventis Investigational Site Number 840789, Lexington, Kentucky, 40503, United States|Sanofi-Aventis Investigational Site Number 840850, Lexington, Kentucky, 40504, United States|Sanofi-Aventis Investigational Site Number 840862, Baton Rouge, Louisiana, 70808, United States|Sanofi-Aventis Investigational Site Number 840879, Shreveport, Louisiana, 71101, United States|Sanofi-Aventis Investigational Site Number 840764, Hyattsville, Maryland, 20783, United States|Sanofi-Aventis Investigational Site Number 840871, Rockville, Maryland, 20850, United States|Sanofi-Aventis Investigational Site Number 840851, Dartmouth, Massachusetts, 2747, United States|Sanofi-Aventis Investigational Site Number 840708, Kalamazoo, Michigan, 49001, United States|Sanofi-Aventis Investigational Site Number 840774, Bloomington, Minnesota, 55435, United States|Sanofi-Aventis Investigational Site Number 840704, Eagan, Minnesota, 55122, United States|Sanofi-Aventis Investigational Site Number 840717, Picayune, Mississippi, 39466, United States|Sanofi-Aventis Investigational Site Number 840765, St Louis, Missouri, 63104, United States|Sanofi-Aventis Investigational Site Number 840875, Las Vegas, Nevada, 89119, United States|Sanofi-Aventis Investigational Site Number 840866, Pahrump, Nevada, 89048, United States|Sanofi-Aventis Investigational Site Number 840766, New York City, New York, 10021, United States|Sanofi-Aventis Investigational Site Number 840865, New York, New York, 10010, United States|Sanofi-Aventis Investigational Site Number 840874, Staten Island, New York, 10301, United States|Sanofi-Aventis Investigational Site Number 840762, West Seneca, New York, 14224, United States|Sanofi-Aventis Investigational Site Number 840747, Burlington, North Carolina, 27215, United States|Sanofi-Aventis Investigational Site Number 840760, Greensboro, North Carolina, 27401, United States|Sanofi-Aventis Investigational Site Number 840712, High Point, North Carolina, 27262, United States|Sanofi-Aventis Investigational Site Number 840780, Bismarck, North Dakota, 58501, United States|Sanofi-Aventis Investigational Site Number 840877, Fargo, North Dakota, 58103, United States|Sanofi-Aventis Investigational Site Number 840777, Athens, Ohio, 45701, United States|Sanofi-Aventis Investigational Site Number 840741, Cleveland, Ohio, 44122, United States|Sanofi-Aventis Investigational Site Number 840728, Dayton, Ohio, 45458, United States|Sanofi-Aventis Investigational Site Number 840709, Mentor, Ohio, 44060, United States|Sanofi-Aventis Investigational Site Number 840716, Norman, Oklahoma, 73069, United States|Sanofi-Aventis Investigational Site Number 840701, Medford, Oregon, 97504, United States|Sanofi-Aventis Investigational Site Number 840751, Beaver, Pennsylvania, 15009, United States|Sanofi-Aventis Investigational Site Number 840798, Red Lion, Pennsylvania, 17356, United States|Sanofi-Aventis Investigational Site Number 840792, Columbia, South Carolina, 29201, United States|Sanofi-Aventis Investigational Site Number 840740, Simpsonville, South Carolina, 29681, United States|Sanofi-Aventis Investigational Site Number 840726, Taylors, South Carolina, 29687-4105, United States|Sanofi-Aventis Investigational Site Number 840711, Bristol, Tennessee, 37620, United States|Sanofi-Aventis Investigational Site Number 840853, Colleyville, Texas, 76034, United States|Sanofi-Aventis Investigational Site Number 840730, Houston, Texas, 77030, United States|Sanofi-Aventis Investigational Site Number 840854, San Antonio, Texas, 78218, United States|Sanofi-Aventis Investigational Site Number 840796, Clinton, Utah, 84015, United States|Sanofi-Aventis Investigational Site Number 840755, Salt Lake City, Utah, 84102, United States|Sanofi-Aventis Investigational Site Number 840756, Salt Lake City, Utah, 84107, United States|Sanofi-Aventis Investigational Site Number 840758, Salt Lake City, Utah, 84107, United States|Sanofi-Aventis Investigational Site Number 840753, Norfolk, Virginia, 23510, United States|Sanofi-Aventis Investigational Site Number 840770, Norfolk, Virginia, 23510, United States|Sanofi-Aventis Investigational Site Number 840752, Richmond, Virginia, 23220, United States|Sanofi-Aventis Investigational Site Number 840757, Virginia Beach, Virginia, 23502, United States|Sanofi-Aventis Investigational Site Number 840735, Spokane, Washington, 99209, United States|Sanofi-Aventis Investigational Site Number 040706, Graz, 8036, Austria|Sanofi-Aventis Investigational Site Number 040704, Vienna, 1060, Austria|Sanofi-Aventis Investigational Site Number 040707, Wels, 4600, Austria|Sanofi-Aventis Investigational Site Number 040702, Wien, 1030, Austria|Sanofi-Aventis Investigational Site Number 040701, Wien, 1100, Austria|Sanofi-Aventis Investigational Site Number 040705, Wien, 1100, Austria|Sanofi-Aventis Investigational Site Number 124710, London, N6A 5R8, Canada|Sanofi-Aventis Investigational Site Number 124712, Mirabel, J7J 2K8, Canada|Sanofi-Aventis Investigational Site Number 124703, Saskatoon, S7K 3H3, Canada|Sanofi-Aventis Investigational Site Number 124713, Scarborough, M1E 5E9, Canada|Sanofi-Aventis Investigational Site Number 124711, Sherbrooke, J1H 5N4, Canada|Sanofi-Aventis Investigational Site Number 124704, Smiths Falls, K7A 4W8, Canada|Sanofi-Aventis Investigational Site Number 124705, St-Romuald, G6W 5M6, Canada|Sanofi-Aventis Investigational Site Number 124716, Sudbury, P3E 2P2, Canada|Sanofi-Aventis Investigational Site Number 124701, Thornhill, L4J 8L7, Canada|Sanofi-Aventis Investigational Site Number 124708, Vancouver, V5Z 1C6, Canada|Sanofi-Aventis Investigational Site Number 250704, Armentieres, 59427, France|Sanofi-Aventis Investigational Site Number 250707, La Rochelle Cedex, 17019, France|Sanofi-Aventis Investigational Site Number 250705, Labarthe Sur Leze, 31860, France|Sanofi-Aventis Investigational Site Number 250702, Le Creusot, 71200, France|Sanofi-Aventis Investigational Site Number 250701, Strasbourg, 67091, France|Sanofi-Aventis Investigational Site Number 276708, Asslar, 35614, Germany|Sanofi-Aventis Investigational Site Number 276704, Berlin, 10115, Germany|Sanofi-Aventis Investigational Site Number 276703, Künzing, 94550, Germany|Sanofi-Aventis Investigational Site Number 276706, Leipzig, 04103, Germany|Sanofi-Aventis Investigational Site Number 276707, Pirna, 01796, Germany|Sanofi-Aventis Investigational Site Number 276702, Sulzbach-Rosenberg, 92237, Germany|Sanofi-Aventis Investigational Site Number 276701, Würzburg, 97072, Germany|Sanofi-Aventis Investigational Site Number 300705, Athens, 10552, Greece|Sanofi-Aventis Investigational Site Number 300703, Athens, Greece|Sanofi-Aventis Investigational Site Number 300704, Athens, Greece|Sanofi-Aventis Investigational Site Number 300701, Thessaloniki, 56429, Greece|Sanofi-Aventis Investigational Site Number 320702, Guatemala, 01010, Guatemala|Sanofi-Aventis Investigational Site Number 320701, Guatemala, 01014, Guatemala|Sanofi-Aventis Investigational Site Number 320703, Guatemala, Guatemala|Sanofi-Aventis Investigational Site Number 320704, Guatemala, Guatemala|Sanofi-Aventis Investigational Site Number 356701, Bangalore, 560010, India|Sanofi-Aventis Investigational Site Number 356703, Bangalore, 560052, India|Sanofi-Aventis Investigational Site Number 356702, Hyderabad, 500001, India|Sanofi-Aventis Investigational Site Number 356704, Nagpur, 440012, India|Sanofi-Aventis Investigational Site Number 484703, Merida, 97000, Mexico|Sanofi-Aventis Investigational Site Number 484701, Tlalnepantla, 53160, Mexico|Sanofi-Aventis Investigational Site Number 484704, Zapopan, 44030, Mexico|Sanofi-Aventis Investigational Site Number 604703, Lima, Lima 27, Peru|Sanofi-Aventis Investigational Site Number 604701, Lima, LIMA 31, Peru|Sanofi-Aventis Investigational Site Number 604702, Lima, Peru|Sanofi-Aventis Investigational Site Number 604705, Lima, Peru|Sanofi-Aventis Investigational Site Number 630714, Carolina, 00983, Puerto Rico|Sanofi-Aventis Investigational Site Number 630715, Carolina, 00983, Puerto Rico|Sanofi-Aventis Investigational Site Number 642711, Alba Iulia, 510 217, Romania|Sanofi-Aventis Investigational Site Number 642702, Bacau, 600164, Romania|Sanofi-Aventis Investigational Site Number 642709, Baia Mare, 430031, Romania|Sanofi-Aventis Investigational Site Number 642701, Brasov, 500326, Romania|Sanofi-Aventis Investigational Site Number 642712, Bucuresti, 010507, Romania|Sanofi-Aventis Investigational Site Number 642714, Bucuresti, 20475, Romania|Sanofi-Aventis Investigational Site Number 642705, Constanta, 900591, Romania|Sanofi-Aventis Investigational Site Number 642707, Galati, 800575, Romania|Sanofi-Aventis Investigational Site Number 642703, Ploiesti, 100097, Romania|Sanofi-Aventis Investigational Site Number 642713, Resita, 320076, Romania|Sanofi-Aventis Investigational Site Number 642708, Satu Mare, 440055, Romania|Sanofi-Aventis Investigational Site Number 642706, Targu Mures, 540061, Romania|Sanofi-Aventis Investigational Site Number 642715, Timisoara, 300456, Romania|Sanofi-Aventis Investigational Site Number 642710, Timisoara, 300593, Romania|Sanofi-Aventis Investigational Site Number 792702, Erzurum, Turkey|Sanofi-Aventis Investigational Site Number 792705, Istanbul, Turkey
URL: https://clinicaltrials.gov/show/NCT00763815

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D336 Pioglitazone small molecule DB01132 Details
D089 Metformin small molecule DB00331 Details