Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine 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 (with or without metformin) 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: Metformin |
| Phase | Phase 3 |
| Sponsor | Sanofi |
| Responsible Party | Sanofi |
| ClinicalTrials.gov Identifier | NCT02058160 |
| First Received | February 6, 2014 |
| Last Updated | March 19, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 6, 2014 |
|---|---|
| Last Updated Date | March 19, 2014 |
| Start Date | January 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 the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes |
|---|---|
| Official Title | A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With T2DM |
| Brief Summary | Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine 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 (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes |
| Detailed Description | Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety 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: Metformin Pharmaceutical form:tablet Route of administration: oral administration |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 700 |
| Estimated Completion Date | August 2015 |
| Estimated Primary Completion Date | August 2015 |
| Eligibility Criteria | Inclusion criteria : - Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit. - Treatment with basal insulin for at least 6 months before the screening visit. - Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit. - Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40U/day for at least 2 months prior to the screening visit. - For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of: - metformin (more than or equal to1500mg/day or maximal tolerated dose), - a sulfonylurea - a glinide, - a dipeptidyl-peptidase-4 inhibitor - a sodium glucose co-transporter 2 inhibitor - Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit, - Signed written informed consent. Exclusion criteria: - Age under legal age of adulthood at screening visit - HbA1c at screening visit less than 7.5% or above 10%. - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. - Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening. - Previous use of insulin regimen other than basal insulin e.g. prandial or pre-mixed insulin. (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator). - History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability 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. - 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) - Any contraindication to metformin use, according to local labeling, if the patient is taking metformin. - Patient who has a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockroft and Gault formula) or end-stage renal disease for patients, not treated with metformin. Exclusion criteria for randomization: - HbA1c less than 7% or above 10% . - Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the self-measurements for 7 days the week before randomization visit is above 140 mg/dL (7.8 mmol/L). - Average insulin glargine daily dose less than 20U or above 50U ( in the week before randomization visit). - 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, Canada, Denmark, Estonia, Lithuania, Spain, Sweden |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02058160 |
|---|---|
| Other Study ID Numbers | EFC12405 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Sanofi |
| Study Sponsor | Sanofi |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Sciences & Operations Sanofi |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Investigational Site Number 840570 | Sun City, Arizona, United States, 85351 Recruiting |
|---|---|
| Investigational Site Number 840562 | Tempe, Arizona, United States Recruiting |
| Investigational Site Number 840542 | Hot Springs, Arkansas, United States, 71913 Recruiting |
| Investigational Site Number 840517 | Little Rock, Arkansas, United States, 72205 Recruiting |
| Investigational Site Number 840537 | Little Rock, Arkansas, United States, 72205 Recruiting |
| Investigational Site Number 840523 | Searcy, Arkansas, United States, 72143 Recruiting |
| Investigational Site Number 840568 | Bell Gardens, California, United States, 90201 Recruiting |
| Investigational Site Number 840550 | Chico, California, United States, 91710 Recruiting |
| Investigational Site Number 840529 | Chula Vista, California, United States, 91911 Recruiting |
| Investigational Site Number 840566 | Fresno, California, United States, 93720 Recruiting |
| Investigational Site Number 840552 | Greenbrae, California, United States, 94904 Recruiting |
| Investigational Site Number 840578 | Lancaster, California, United States, 93534 Recruiting |
| Investigational Site Number 840581 | Los Angeles, California, United States, 90057 Recruiting |
| Investigational Site Number 840511 | Northridge, California, United States, 91325 Recruiting |
| Investigational Site Number 840573 | Palm Springs, California, United States, 92262 Recruiting |
| Investigational Site Number 840559 | Port Hueneme, California, United States, 93041 Recruiting |
| Investigational Site Number 840536 | San Ramon, California, United States, 94583 Recruiting |
| Investigational Site Number 840567 | Santa Ana, California, United States, 92704 Recruiting |
| Investigational Site Number 840569 | Tarzana, California, United States, 91356 Recruiting |
| Investigational Site Number 840509 | Denver, Colorado, United States, 80246 Recruiting |
| Investigational Site Number 840510 | Miami, Florida, United States, 33156-7563 Recruiting |
| Investigational Site Number 840521 | New Port Richey, Florida, United States, 34652 Recruiting |
| Investigational Site Number 840602 | Ocala, Florida, United States, 34471 Recruiting |
| Investigational Site Number 840538 | Ocoee, Florida, United States, 34761 Recruiting |
| Investigational Site Number 840534 | Palm Harbor, Florida, United States, 34684 Recruiting |
| Investigational Site Number 840501 | Lawrenceville, Georgia, United States, 30046 Recruiting |
| Investigational Site Number 840525 | Roswell, Georgia, United States, 30076 Recruiting |
| Investigational Site Number 840588 | Idaho Falls, Idaho, United States, 83404 Recruiting |
| Investigational Site Number 840580 | Arlington Heights, Illinois, United States, 60005 Recruiting |
| Investigational Site Number 840519 | Chicago, Illinois, United States, 60607 Recruiting |
| Investigational Site Number 840556 | Springfield, Illinois, United States, 62704 Recruiting |
| Investigational Site Number 840543 | Avon, Indiana, United States, 46123 Recruiting |
| Investigational Site Number 840555 | Avon, Indiana, United States, 46123 Recruiting |
| Investigational Site Number 840585 | Evansville, Indiana, United States, 47714 Recruiting |
| Investigational Site Number 840565 | Evansville, Indiana, United States, 47713 Recruiting |
| Investigational Site Number 840507 | Indianapolis, Indiana, United States, 46260 Recruiting |
| Investigational Site Number 840516 | Louisville, Kentucky, United States, 40213 Recruiting |
| Investigational Site Number 840595 | Auburn, Maine, United States, 04210 Recruiting |
| Investigational Site Number 840522 | Rockville, Maryland, United States, 20852 Recruiting |
| Investigational Site Number 840533 | Bloomfield Hills, Michigan, United States Recruiting |
| Investigational Site Number 840518 | Chesterfield, Michigan, United States, 48047 Recruiting |
| Investigational Site Number 840505 | Dearborn, Michigan, United States, 48124 Recruiting |
| Investigational Site Number 840575 | Flint, Michigan, United States, 48504 Recruiting |
| Investigational Site Number 840527 | Kalamazoo, Michigan, United States, 49048 Recruiting |
| Investigational Site Number 840558 | Butte, Montana, United States, 59701 Recruiting |
| Investigational Site Number 840587 | Kalispell, Montana, United States, 59901 Recruiting |
| Investigational Site Number 840600 | Henderson, Nevada, United States, 89074 Recruiting |
| Investigational Site Number 840599 | Las Vegas, Nevada, United States, 89148 Recruiting |
| Investigational Site Number 840532 | Las Vegas, Nevada, United States, 89119 Recruiting |
| Investigational Site Number 840539 | Nashua, New Hampshire, United States, 03063 Recruiting |
| Investigational Site Number 840576 | Albuquerque, New Mexico, United States, 87131 Recruiting |
| Investigational Site Number 840531 | New Hyde Park, New York, United States, 11042 Recruiting |
| Investigational Site Number 840540 | Hickory, North Carolina, United States, 28601 Recruiting |
| Investigational Site Number 840513 | Morehead City, North Carolina, United States, 28557 Recruiting |
| Investigational Site Number 840592 | Salisbury, North Carolina, United States, 28144 Recruiting |
| Investigational Site Number 840535 | Wilmington, North Carolina, United States, 28401 Recruiting |
| Investigational Site Number 840515 | Winston-Salem, North Carolina, United States, 27103 Recruiting |
| Investigational Site Number 840579 | Columbus, Ohio, United States, 43213 Recruiting |
| Investigational Site Number 840524 | Dayton, Ohio, United States, 45439 Recruiting |
| Investigational Site Number 840503 | Maumee, Ohio, United States, 43537 Recruiting |
| Investigational Site Number 840551 | Smithfield, Pennsylvania, United States, 15478 Recruiting |
| Investigational Site Number 840584 | Tipton, Pennsylvania, United States, 16684 Recruiting |
| Investigational Site Number 840605 | Amarillo, Texas, United States, 79106 Recruiting |
| Investigational Site Number 840598 | Austin, Texas, United States, 78731 Recruiting |
| Investigational Site Number 840553 | Austin, Texas, United States, 78731 Recruiting |
| Investigational Site Number 840502 | Corpus Christi, Texas, United States, 78404 Recruiting |
| Investigational Site Number 840601 | Dallas, Texas, United States, 75208 Recruiting |
| Investigational Site Number 840547 | Dallas, Texas, United States, 75230 Recruiting |
| Investigational Site Number 840530 | Dallas, Texas, United States, 75231 Recruiting |
| Investigational Site Number 840554 | Edinburg, Texas, United States, 78539 Recruiting |
| Investigational Site Number 840514 | Hurst, Texas, United States, 76054 Recruiting |
| Investigational Site Number 840512 | Draper, Utah, United States, 84020 Recruiting |
| Investigational Site Number 840591 | Murray, Utah, United States, 84123 Recruiting |
| Investigational Site Number 840526 | Ogden, Utah, United States, 84405 Recruiting |
| Investigational Site Number 840606 | Richmond, Virginia, United States, 23227 Recruiting |
| Investigational Site Number 840603 | Weber City, Virginia, United States, 24290 Recruiting |
| Investigational Site Number 840571 | Federal Way, Washington, United States, 98003 Recruiting |
| Investigational Site Number 840609 | Tacoma, Washington, United States, 98415-0299 Recruiting |
| Investigational Site Number 840546 | Milwaukee, Wisconsin, United States, 53209-0996 Recruiting |
| Investigational Site Number 124504 | Beamsville, Canada, L0R 1B0 Recruiting |
| Investigational Site Number 124502 | Guelph, Canada, N1H 1B1 Recruiting |
| Investigational Site Number 124507 | Kelowna, Canada, V1Y 1Z9 Recruiting |
| Investigational Site Number 124506 | Mississauga, Canada, L5M 2V8 Recruiting |
| Investigational Site Number 124509 | St-Romuald, Canada, G6W 5M6 Recruiting |
| Investigational Site Number 124503 | Toronto, Canada, M9V 4B4 Recruiting |
| Investigational Site Number 124510 | Toronto, Canada, M9W 4L9 Recruiting |
| Investigational Site Number 124501 | Vancouver, Canada, V5Z 1M9 Recruiting |
| Investigational Site Number 124508 | Victoria, Canada, V8V 4A1 Recruiting |
| Investigational Site Number 208503 | Aarhus C, Denmark, 8000 Recruiting |
| Investigational Site Number 208502 | Kolding, Denmark, 6000 Recruiting |
| Investigational Site Number 208501 | København Nv, Denmark, 2400 Recruiting |
| Investigational Site Number 208505 | København S, Denmark, 2300 Recruiting |
| Investigational Site Number 208504 | Viborg, Denmark, 8800 Recruiting |
| Investigational Site Number 233502 | Pärnu, Estonia, 80018 Recruiting |
| Investigational Site Number 233503 | Tallinn, Estonia, 10138 Recruiting |
| Investigational Site Number 233501 | Tartu, Estonia, 50406 Recruiting |
| Investigational Site Number 440505 | Kedainiai, Lithuania, LT-57164 Recruiting |
| Investigational Site Number 440504 | Klaipeda, Lithuania, LT-92253 Recruiting |
| Investigational Site Number 724504 | Barcelona, Spain, 08035 Recruiting |
| Investigational Site Number 724501 | Sabadell, Spain, 08208 Recruiting |
| Investigational Site Number 724502 | Valencia, Spain, 46014 Recruiting |
| Investigational Site Number 752503 | Malmö, Sweden, 211 52 Recruiting |
| Investigational Site Number 752504 | Rättvik, Sweden, 79530 Recruiting |
| Investigational Site Number 752505 | Stockholm, Sweden, 11522 Recruiting |
| Investigational Site Number 752502 | Vällingby, Sweden, 16268 Recruiting |