Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM
Overview[ - collapse ][ - ]
| Purpose | Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Insulin glargine/lixisenatide HOE901/AVE0010 Drug: Insulin glargine HOE901 Drug: Lixisenatide AVE0010 Drug: Metformin |
| Phase | Phase 3 |
| Sponsor | Sanofi |
| Responsible Party | Sanofi |
| ClinicalTrials.gov Identifier | NCT02058147 |
| First Received | February 6, 2014 |
| Last Updated | April 16, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 6, 2014 |
|---|---|
| Last Updated Date | April 16, 2014 |
| Start Date | February 2014 |
| Estimated Primary Completion Date | August 2015 |
| Current Primary Outcome Measures | Change in HbA1c from baseline [Time Frame: week 30] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM |
|---|---|
| Official Title | A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus T2DM |
| Brief Summary | Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in HbA1c change from baseline to week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in patients with type 2 diabetes |
| Detailed Description | Approximately 37 weeks including up to 6 weeks of screening, 30-week treatment period, and a 3 days follow-up period |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Insulin glargine/lixisenatide HOE901/AVE0010 Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection Drug: Insulin glargine HOE901 Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection Drug: Lixisenatide AVE0010 Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection Drug: Metformin Pharmaceutical form: tablet Route of administration: Oral |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1125 |
| Estimated Completion Date | August 2015 |
| Estimated Primary Completion Date | August 2015 |
| Eligibility Criteria | Inclusion criteria : - Patients with type 2 diabetes mellitus diagnosed for at least 1 year before the screening visit, treated for at least 3 months prior to visit 1 with metformin alone or metformin and a second oral anti-diabetic treatment that can be a sulfonylurea, or a glinide, or a sodium glucose co-transporter 2 inhibitor, and who are not adequately controlled with this treatment; - Signed written informed consent Exclusion criteria: - HbA1c at screening visit: - less than 7.5% or more than 10% for patients previously treated with metformin alone, - less than 7.0% or more than 9 % for patients previously treated with metformin and a second oral anti-diabetic treatment; - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method; - Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucose-lowering agents during the 3 months before screening. - Previous Treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes, at the discretion of the trial physician) - History of discontinuation of a previous treatment with a GLP-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy; - Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide. - Any contraindication to metformin use, according to local labeling - Use of weight loss drugs within 3 months prior to screening visit. - Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period. - History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). - Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit - At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m² - At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range, - At screening visit ALT or AST more than 3 ULN - At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L) Exclusion Criteria for randomization at the end of the screening period: - HbA1c less than 7% or above 10%; - Fasting Plasma glucose above 250mg/dL (13.9 mmol/L); - Metformin maximal tolerated dose less than 1500 mg/day; - Amylase and/or lipase more than 3 ULN; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: For site information, send an email with site number to Contact-Us@sanofi.com |
| Location Countries | United States, Australia, Belgium, Chile, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Spain, Sweden, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02058147 |
|---|---|
| Other Study ID Numbers | EFC12404 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Sanofi |
| Study Sponsor | Sanofi |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Sciences & Operations Sanofi |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Investigational Site Number 840027 | Phoenix, Arizona, United States, 85028 Recruiting |
|---|---|
| Investigational Site Number 840032 | Sun City, Arizona, United States, 85351 Recruiting |
| Investigational Site Number 840023 | Tempe, Arizona, United States Recruiting |
| Investigational Site Number 840062 | Tempe, Arizona, United States, 85282 Recruiting |
| Investigational Site Number 840084 | Little Rock, Arkansas, United States, 72205 Recruiting |
| Investigational Site Number 840035 | Searcy, Arkansas, United States, 72143 Recruiting |
| Investigational Site Number 840100 | Anaheim, California, United States, 92801 Recruiting |
| Investigational Site Number 840065 | Bell Gardens, California, United States, 90201 Recruiting |
| Investigational Site Number 840090 | Chino, California, United States, 91710 Recruiting |
| Investigational Site Number 840002 | Chula Vista, California, United States, 91911 Recruiting |
| Investigational Site Number 840013 | Concord, California, United States, 94520 Recruiting |
| Investigational Site Number 840053 | Fresno, California, United States, 93720 Recruiting |
| Investigational Site Number 840017 | La Jolla, California, United States, 92037 Recruiting |
| Investigational Site Number 840070 | Lancaster, California, United States, 93534 Recruiting |
| Investigational Site Number 840044 | Los Angeles, California, United States, 90057 Recruiting |
| Investigational Site Number 840101 | Mission Hills, California, United States, 91345 Recruiting |
| Investigational Site Number 840120 | Newport Beach, California, United States, 92660 Recruiting |
| Investigational Site Number 840005 | Northridge, California, United States, 91325 Recruiting |
| Investigational Site Number 840034 | Palm Springs, California, United States, 92262 Recruiting |
| Investigational Site Number 840074 | Port Hueneme, California, United States, 93041 Recruiting |
| Investigational Site Number 840068 | San Ramon, California, United States, 94583 Recruiting |
| Investigational Site Number 840067 | Santa Ana, California, United States, 92704 Recruiting |
| Investigational Site Number 840029 | Tarzana, California, United States, 91356 Recruiting |
| Investigational Site Number 840006 | Temecula, California, United States, 92591 Recruiting |
| Investigational Site Number 840078 | West Hills, California, United States, 91345 Recruiting |
| Investigational Site Number 840038 | Denver, Colorado, United States, 80246 Recruiting |
| Investigational Site Number 840059 | Denver, Colorado, United States, 80220 Recruiting |
| Investigational Site Number 840104 | Bradenton, Florida, United States, 34208 Recruiting |
| Investigational Site Number 840098 | Miami, Florida, United States, 33156-7563 Recruiting |
| Investigational Site Number 840014 | New Port Richey, Florida, United States, 34652 Recruiting |
| Investigational Site Number 840047 | Ocoee, Florida, United States, 34761 Recruiting |
| Investigational Site Number 840056 | Palm Harbor, Florida, United States, 34684 Recruiting |
| Investigational Site Number 840054 | Lawrenceville, Georgia, United States, 30046 Active, not recruiting |
| Investigational Site Number 840108 | Idaho Falls, Idaho, United States, 83404 Recruiting |
| Investigational Site Number 840075 | Arlington Heights, Illinois, United States, 60005 Recruiting |
| Investigational Site Number 840080 | Chicago, Illinois, United States, 60607 Recruiting |
| Investigational Site Number 840116 | Chicago, Illinois, United States, 60616 Recruiting |
| Investigational Site Number 840050 | Springfield, Illinois, United States, 62704 Recruiting |
| Investigational Site Number 840076 | Avon, Indiana, United States, 46123 Recruiting |
| Investigational Site Number 840015 | Avon, Indiana, United States, 46123 Recruiting |
| Investigational Site Number 840008 | Avon, Indiana, United States, 46123 Recruiting |
| Investigational Site Number 840082 | Evansville, Indiana, United States, 47713 Recruiting |
| Investigational Site Number 840060 | Evansville, Indiana, United States, 47714 Recruiting |
| Investigational Site Number 840031 | Evansville, Indiana, United States, 47714 Recruiting |
| Investigational Site Number 840085 | Indianapolis, Indiana, United States, 46260 Recruiting |
| Investigational Site Number 840012 | Valparaiso, Indiana, United States Recruiting |
| Investigational Site Number 840025 | Waterloo, Iowa, United States, 50702 Recruiting |
| Investigational Site Number 840022 | Lexington, Kentucky, United States, 40504 Recruiting |
| Investigational Site Number 840007 | Louisville, Kentucky, United States, 40213 Recruiting |
| Investigational Site Number 840097 | Auburn, Maine, United States, 04210 Recruiting |
| Investigational Site Number 840063 | Rockville, Maryland, United States, 20852 Recruiting |
| Investigational Site Number 840028 | Bloomfield Hills, Michigan, United States Recruiting |
| Investigational Site Number 840071 | Chesterfield, Michigan, United States, 48047 Recruiting |
| Investigational Site Number 840001 | Dearborn, Michigan, United States, 48124 Recruiting |
| Investigational Site Number 840091 | Kalamazoo, Michigan, United States, 49048 Recruiting |
| Investigational Site Number 840024 | Chesterfield, Missouri, United States, 63017 Recruiting |
| Investigational Site Number 840057 | Butte, Montana, United States, 59701 Recruiting |
| Investigational Site Number 840109 | Henderson, Nevada, United States, 89074 Recruiting |
| Investigational Site Number 840052 | Las Vegas, Nevada, United States, 89148 Recruiting |
| Investigational Site Number 840069 | Nashua, New Hampshire, United States, 03063 Recruiting |
| Investigational Site Number 840011 | Albuquerque, New Mexico, United States, 87131 Recruiting |
| Investigational Site Number 840030 | New Hyde Park, New York, United States, 11042 Recruiting |
| Investigational Site Number 840096 | Syracuse, New York, United States, 13214-2016 Recruiting |
| Investigational Site Number 840039 | Asheville, North Carolina, United States, 28803 Recruiting |
| Investigational Site Number 840021 | Hickory, North Carolina, United States, 28601 Active, not recruiting |
| Investigational Site Number 840046 | Morehead City, North Carolina, United States, 28557 Recruiting |
| Investigational Site Number 840072 | Morganton, North Carolina, United States, 28655 Recruiting |
| Investigational Site Number 840110 | Salisbury, North Carolina, United States, 28144 Active, not recruiting |
| Investigational Site Number 840095 | Wilmington, North Carolina, United States, 28401 Recruiting |
| Investigational Site Number 840099 | Winston-Salem, North Carolina, United States, 27103 Active, not recruiting |
| Investigational Site Number 840004 | Columbus, Ohio, United States, 43213 Recruiting |
| Investigational Site Number 840016 | Maumee, Ohio, United States, 43537 Recruiting |
| Investigational Site Number 840103 | Eugene, Oregon, United States Recruiting |
| Investigational Site Number 840036 | Pittsburgh, Pennsylvania, United States, 15473 Recruiting |
| Investigational Site Number 840043 | Tipton, Pennsylvania, United States, 16684 Recruiting |
| Investigational Site Number 840058 | Anderson, South Carolina, United States, 29621 Recruiting |
| Investigational Site Number 840049 | Greer, South Carolina, United States, 29651 Recruiting |
| Investigational Site Number 840114 | Rapid City, South Dakota, United States, 57701 Recruiting |
| Investigational Site Number 840112 | Bristol, Tennessee, United States, 37620 Recruiting |
| Investigational Site Number 840094 | Knoxville, Tennessee, United States, 37912 Recruiting |
| Investigational Site Number 840051 | Austin, Texas, United States, 78758 Recruiting |
| Investigational Site Number 840066 | Corpus Christi, Texas, United States, 78404 Recruiting |
| Investigational Site Number 840064 | Dallas, Texas, United States, 75230 Recruiting |
| Investigational Site Number 840111 | Dallas, Texas, United States, 75208 Recruiting |
| Investigational Site Number 840003 | Dallas, Texas, United States, 75231 Recruiting |
| Investigational Site Number 840088 | Edinburg, Texas, United States, 78539 Recruiting |
| Investigational Site Number 840055 | Houston, Texas, United States, 77004 Recruiting |
| Investigational Site Number 840079 | Hurst, Texas, United States, 76054 Recruiting |
| Investigational Site Number 840073 | N Richland Hill, Texas, United States, 76180 Recruiting |
| Investigational Site Number 840019 | San Antonio, Texas, United States, 78229 Recruiting |
| Investigational Site Number 840037 | Draper, Utah, United States, 84020 Recruiting |
| Investigational Site Number 840093 | Ogden, Utah, United States, 84405 Recruiting |
| Investigational Site Number 840041 | Salt Lake City, Utah, United States, 84107 Recruiting |
| Investigational Site Number 840061 | Salt Lake City, Utah, United States, 84102 Recruiting |
| Investigational Site Number 840040 | Chesapeake, Virginia, United States, 23321 Recruiting |
| Investigational Site Number 840092 | Norfolk, Virginia, United States, 23510 Recruiting |
| Investigational Site Number 840045 | Norfolk, Virginia, United States, 23510 Recruiting |
| Investigational Site Number 840010 | Weber City, Virginia, United States, 24290 Recruiting |
| Investigational Site Number 840077 | Federal Way, Washington, United States, 98003 Recruiting |
| Investigational Site Number 840102 | Renton, Washington, United States, 98055 Recruiting |
| Investigational Site Number 840033 | Milwaukee, Wisconsin, United States, 53209-0996 Recruiting |
| Investigational Site Number 036003 | Keswick, Australia, 5035 Recruiting |
| Investigational Site Number 056001 | Leuven, Belgium, 3000 Recruiting |
| Investigational Site Number 152001 | Santiago, Chile, 7591047 Recruiting |
| Investigational Site Number 208003 | Aarhus C, Denmark, 8000 Recruiting |
| Investigational Site Number 208002 | Kolding, Denmark, 6000 Recruiting |
| Investigational Site Number 208001 | København Nv, Denmark, 2400 Recruiting |
| Investigational Site Number 208005 | København S, Denmark, 2300 Recruiting |
| Investigational Site Number 208004 | Viborg, Denmark, 8800 Recruiting |
| Investigational Site Number 233004 | Paide, Estonia, 72713 Recruiting |
| Investigational Site Number 233002 | Pärnu, Estonia, 80018 Recruiting |
| Investigational Site Number 233003 | Tallinn, Estonia, 13415 Recruiting |
| Investigational Site Number 233001 | Viljandimaa, Estonia, 71024 Recruiting |
| Investigational Site Number 250002 | La Rochelle Cedex, France, 17019 Recruiting |
| Investigational Site Number 250005 | Le Creusot, France, 71200 Recruiting |
| Investigational Site Number 250003 | Pierre Benite, France, 69310 Recruiting |
| Investigational Site Number 250001 | Venissieux, France, 69200 Recruiting |
| Investigational Site Number 276005 | Berlin, Germany, 10115 Recruiting |
| Investigational Site Number 276003 | Berlin, Germany, 13125 Recruiting |
| Investigational Site Number 276004 | Dortmund, Germany, 44137 Recruiting |
| Investigational Site Number 276001 | Dresden, Germany, 01307 Recruiting |
| Investigational Site Number 276006 | Hamburg, Germany, 20253 Recruiting |
| Investigational Site Number 276002 | Neumünster, Germany, 24534 Recruiting |
| Investigational Site Number 348003 | Balatonfüred, Hungary, 8230 Recruiting |
| Investigational Site Number 348002 | Budapest, Hungary, 1138 Recruiting |
| Investigational Site Number 348012 | Sátoraljaújhely, Hungary, 3980 Recruiting |
| Investigational Site Number 380002 | Bologna, Italy, 40138 Recruiting |
| Investigational Site Number 380001 | Milano, Italy, 20132 Recruiting |
| Investigational Site Number 428002 | Riga, Latvia, LV-1011 Recruiting |
| Investigational Site Number 428003 | Riga, Latvia, LV-1011 Recruiting |
| Investigational Site Number 428004 | Riga, Latvia, LV-1050 Recruiting |
| Investigational Site Number 428001 | Sigulda, Latvia, LV-2150 Recruiting |
| Investigational Site Number 440003 | Jonava, Lithuania, LT-55201 Recruiting |
| Investigational Site Number 440007 | Kaunas, Lithuania, LT-50009 Recruiting |
| Investigational Site Number 440002 | Kaunas, Lithuania, LT-49456 Recruiting |
| Investigational Site Number 440004 | Kedainiai, Lithuania, LT-57164 Recruiting |
| Investigational Site Number 440006 | Panevezys, Lithuania, LT-37355 Recruiting |
| Investigational Site Number 440005 | Utena, Lithuania, LT-28151 Recruiting |
| Investigational Site Number 440001 | Vilnius, Lithuania, LT-10323 Recruiting |
| Investigational Site Number 616002 | Bialystok, Poland, 15-435 Recruiting |
| Investigational Site Number 616005 | Krakow, Poland, 31-261 Recruiting |
| Investigational Site Number 616006 | Krakow, Poland, 31-548 Recruiting |
| Investigational Site Number 616007 | Lodz, Poland, 94-074 Recruiting |
| Investigational Site Number 616004 | Szczecin, Poland, 70-506 Recruiting |
| Investigational Site Number 616001 | Warszawa, Poland, 02-507 Recruiting |
| Investigational Site Number 616008 | Zory, Poland, 44-240 Recruiting |
| Investigational Site Number 724012 | Barcelona, Spain, 08003 Recruiting |
| Investigational Site Number 724009 | Granada, Spain, 18012 Recruiting |
| Investigational Site Number 724004 | Hostalets De Balenyà, Spain, 08550 Recruiting |
| Investigational Site Number 724008 | Madrid, Spain, 28034 Recruiting |
| Investigational Site Number 724005 | Madrid, Spain, 28046 Recruiting |
| Investigational Site Number 724001 | Quart De Poblet, Spain, 46930 Recruiting |
| Investigational Site Number 724003 | Sevilla, Spain, 41010 Recruiting |
| Investigational Site Number 752001 | Ljungby, Sweden, 341 82 Recruiting |
| Investigational Site Number 752003 | Malmö, Sweden, 211 52 Recruiting |
| Investigational Site Number 752004 | Rättvik, Sweden, 79530 Recruiting |
| Investigational Site Number 752005 | Stockholm, Sweden, 11522 Recruiting |
| Investigational Site Number 752002 | Vällingby, Sweden, 16268 Recruiting |
| Investigational Site Number 826001 | Coventry, United Kingdom, CV2 2DX Recruiting |
| Investigational Site Number 826002 | Dundee, United Kingdom, DD1 9SI Recruiting |
| Investigational Site Number 826006 | Guildford, United Kingdom, GU2 7XX Recruiting |
| Investigational Site Number 826007 | Leicester, United Kingdom, LE5 4PW Recruiting |
| Investigational Site Number 826003 | Norwich, United Kingdom, NR1 3SR Recruiting |