Type 2 Diabetes Clinical Trial
— LixiLan-OOfficial 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)
Verified date | June 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 1170 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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, a glinide, a sodium glucose co-transporter 2 inhibitor or a dipeptidyl peptidase 4 (DPP4) inhibitors, 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 alanine aminotransferase (ALT) or alkaline phosphatase (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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Investigational Site Number 036005 | Box Hill | |
Australia | Investigational Site Number 036001 | Camperdown | |
Australia | Investigational Site Number 036006 | Kippa Ring | |
Australia | Investigational Site Number 036007 | Logan Central | |
Belgium | Investigational Site Number 056006 | Brussel | |
Belgium | Investigational Site Number 056005 | Brussels | |
Belgium | Investigational Site Number 056001 | Leuven | |
Canada | Investigational Site Number 124004 | Kelowna | |
Canada | Investigational Site Number 124001 | Toronto | |
Canada | Investigational Site Number 124002 | Vancouver | |
Chile | Investigational Site Number 152008 | Osorno | |
Chile | Investigational Site Number 152015 | Puerto Varas | |
Chile | Investigational Site Number 152001 | Santiago | |
Chile | Investigational Site Number 152002 | Santiago | |
Chile | Investigational Site Number 152004 | Santiago | |
Chile | Investigational Site Number 152006 | Santiago | |
Chile | Investigational Site Number 152009 | Santiago | |
Chile | Investigational Site Number 152012 | Santiago | |
Chile | Investigational Site Number 152011 | Talagante | |
Chile | Investigational Site Number 152003 | Temuco | |
Chile | Investigational Site Number 152014 | Temuco | |
Czech Republic | Investigational Site Number 203004 | Beroun | |
Czech Republic | Investigational Site Number 203008 | Ceske Budejovice | |
Czech Republic | Investigational Site Number 203014 | Horovice | |
Czech Republic | Investigational Site Number 203012 | Koprivnice | |
Czech Republic | Investigational Site Number 203001 | Pardubice | |
Czech Republic | Investigational Site Number 203005 | Plzen | |
Czech Republic | Investigational Site Number 203003 | Praha 10 | |
Czech Republic | Investigational Site Number 203009 | Praha 2 | |
Czech Republic | Investigational Site Number 203007 | Praha 5 | |
Czech Republic | Investigational Site Number 203013 | Praha 9 - Klanovice | |
Czech Republic | Investigational Site Number 203006 | Trutnov | |
Czech Republic | Investigational Site Number 203016 | Ujezd U Brna | |
Czech Republic | Investigational Site Number 203015 | Vsetin | |
Denmark | Investigational Site Number 208003 | Aarhus C | |
Denmark | Investigational Site Number 208009 | Horsens | |
Denmark | Investigational Site Number 208001 | København Nv | |
Denmark | Investigational Site Number 208005 | København S | |
Denmark | Investigational Site Number 208002 | Kolding | |
Denmark | Investigational Site Number 208004 | Viborg | |
Estonia | Investigational Site Number 233004 | Paide | |
Estonia | Investigational Site Number 233002 | Pärnu | |
Estonia | Investigational Site Number 233003 | Tallinn | |
Estonia | Investigational Site Number 233001 | Viljandimaa | |
France | Investigational Site Number 250006 | Corbeil Essonnes | |
France | Investigational Site Number 250002 | La Rochelle Cedex | |
France | Investigational Site Number 250003 | Pierre Benite | |
France | Investigational Site Number 250001 | Venissieux | |
Germany | Investigational Site Number 276003 | Berlin | |
Germany | Investigational Site Number 276005 | Berlin | |
Germany | Investigational Site Number 276004 | Dortmund | |
Germany | Investigational Site Number 276001 | Dresden | |
Germany | Investigational Site Number 276007 | Dresden | |
Germany | Investigational Site Number 276006 | Hamburg | |
Germany | Investigational Site Number 276002 | Neumünster | |
Hungary | Investigational Site Number 348003 | Balatonfüred | |
Hungary | Investigational Site Number 348002 | Budapest | |
Hungary | Investigational Site Number 348006 | Budapest | |
Hungary | Investigational Site Number 348007 | Budapest | |
Hungary | Investigational Site Number 348011 | Komárom | |
Hungary | Investigational Site Number 348008 | Nagykanizsa | |
Hungary | Investigational Site Number 348012 | Sátoraljaújhely | |
Hungary | Investigational Site Number 348004 | Szeged | |
Hungary | Investigational Site Number 348010 | Szekesfehervar | |
Hungary | Investigational Site Number 348001 | Zalaegerszeg | |
Italy | Investigational Site Number 380002 | Bologna | |
Italy | Investigational Site Number 380006 | Catanzaro | |
Italy | Investigational Site Number 380001 | Milano | |
Italy | Investigational Site Number 380003 | Napoli | |
Italy | Investigational Site Number 380005 | Roma | |
Latvia | Investigational Site Number 428002 | Riga | |
Latvia | Investigational Site Number 428003 | Riga | |
Latvia | Investigational Site Number 428004 | Riga | |
Latvia | Investigational Site Number 428001 | Sigulda | |
Lithuania | Investigational Site Number 440003 | Jonava | |
Lithuania | Investigational Site Number 440002 | Kaunas | |
Lithuania | Investigational Site Number 440007 | Kaunas | |
Lithuania | Investigational Site Number 440004 | Kedainiai | |
Lithuania | Investigational Site Number 440006 | Panevezys | |
Lithuania | Investigational Site Number 440005 | Utena | |
Lithuania | Investigational Site Number 440001 | Vilnius | |
Mexico | Investigational Site Number 484005 | Aguascalientes | |
Mexico | Investigational Site Number 484001 | Cuernavaca | |
Mexico | Investigational Site Number 484002 | Guadalajara | |
Mexico | Investigational Site Number 484004 | Guadalajara | |
Mexico | Investigational Site Number 484009 | Guadalajara | |
Mexico | Investigational Site Number 484006 | Monterrey | |
Mexico | Investigational Site Number 484007 | Monterrey | |
Mexico | Investigational Site Number 484010 | Zapopan | |
Poland | Investigational Site Number 616002 | Bialystok | |
Poland | Investigational Site Number 616005 | Krakow | |
Poland | Investigational Site Number 616006 | Krakow | |
Poland | Investigational Site Number 616007 | Lodz | |
Poland | Investigational Site Number 616004 | Szczecin | |
Poland | Investigational Site Number 616001 | Warszawa | |
Poland | Investigational Site Number 616003 | Warszawa | |
Poland | Investigational Site Number 616008 | Zory | |
Romania | Investigational Site Number 642008 | Bucharest | |
Romania | Investigational Site Number 642007 | Bucuresti | |
Romania | Investigational Site Number 642009 | Cluj Napoca | |
Romania | Investigational Site Number 642006 | Hunedoara | |
Romania | Investigational Site Number 642005 | Iasi | |
Romania | Investigational Site Number 642002 | Oradea | |
Romania | Investigational Site Number 642001 | Targu Mures | |
Romania | Investigational Site Number 642003 | Timisoara | |
Romania | Investigational Site Number 642004 | Timisoara | |
Russian Federation | Investigational Site Number 643006 | Moscow | |
Russian Federation | Investigational Site Number 643008 | Penza | |
Russian Federation | Investigational Site Number 643012 | Petrozavodsk | |
Russian Federation | Investigational Site Number 643001 | Saint-Petersburg | |
Russian Federation | Investigational Site Number 643014 | Samara | |
Russian Federation | Investigational Site Number 643009 | Saratov | |
Russian Federation | Investigational Site Number 643011 | Saratov | |
Russian Federation | Investigational Site Number 643002 | St-Petersburg | |
Russian Federation | Investigational Site Number 643005 | St-Petersburg | |
Russian Federation | Investigational Site Number 643007 | St-Petersburg | |
Russian Federation | Investigational Site Number 643003 | St. Petersburg | |
Russian Federation | Investigational Site Number 643016 | Tomsk | |
Russian Federation | Investigational Site Number 643004 | Voronezh | |
South Africa | Investigational Site Number 710002 | Cap Town | |
South Africa | Investigational Site Number 710003 | Cape Town | |
South Africa | Investigational Site Number 710005 | Meyerspark | |
South Africa | Investigational Site Number 710007 | Port Elizabeth | |
South Africa | Investigational Site Number 710004 | Pretoria | |
South Africa | Investigational Site Number 710001 | Somerset West | |
South Africa | Investigational Site Number 710006 | Soweto | |
Spain | Investigational Site Number 724012 | Barcelona | |
Spain | Investigational Site Number 724009 | Granada | |
Spain | Investigational Site Number 724004 | Hostalets De Balenyà | |
Spain | Investigational Site Number 724011 | La Coruña | |
Spain | Investigational Site Number 724007 | Lugo | |
Spain | Investigational Site Number 724005 | Madrid | |
Spain | Investigational Site Number 724008 | Madrid | |
Spain | Investigational Site Number 724013 | Palma De Mallorca | |
Spain | Investigational Site Number 724001 | Quart De Poblet | |
Spain | Investigational Site Number 724006 | Sant Joan Despí | |
Spain | Investigational Site Number 724003 | Sevilla | |
Sweden | Investigational Site Number 752001 | Ljungby | |
Sweden | Investigational Site Number 752003 | Malmö | |
Sweden | Investigational Site Number 752004 | Rättvik | |
Sweden | Investigational Site Number 752005 | Stockholm | |
Sweden | Investigational Site Number 752002 | Vällingby | |
Ukraine | Investigational Site Number 804002 | Chernivtsi | |
Ukraine | Investigational Site Number 804009 | Ivano-Frankovsk | |
Ukraine | Investigational Site Number 804006 | Kyiv | |
Ukraine | Investigational Site Number 804007 | Kyiv | |
Ukraine | Investigational Site Number 804010 | Kyiv | |
Ukraine | Investigational Site Number 804012 | Lviv | |
Ukraine | Investigational Site Number 804008 | Vinnytsya | |
Ukraine | Investigational Site Number 804011 | Vinnytsya | |
United Kingdom | Investigational Site Number 826001 | Coventry | |
United Kingdom | Investigational Site Number 826002 | Dundee | |
United Kingdom | Investigational Site Number 826006 | Guildford | |
United Kingdom | Investigational Site Number 826007 | Leicester | |
United Kingdom | Investigational Site Number 826003 | Norwich | |
United States | Investigational Site Number 840011 | Albuquerque | New Mexico |
United States | Investigational Site Number 840100 | Anaheim | California |
United States | Investigational Site Number 840058 | Anderson | South Carolina |
United States | Investigational Site Number 840075 | Arlington Heights | Illinois |
United States | Investigational Site Number 840039 | Asheville | North Carolina |
United States | Investigational Site Number 840089 | Atlanta | Georgia |
United States | Investigational Site Number 840097 | Auburn | Maine |
United States | Investigational Site Number 840059 | Aurora | Colorado |
United States | Investigational Site Number 840051 | Austin | Texas |
United States | Investigational Site Number 840008 | Avon | Indiana |
United States | Investigational Site Number 840015 | Avon | Indiana |
United States | Investigational Site Number 840076 | Avon | Indiana |
United States | Investigational Site Number 840065 | Bell Gardens | California |
United States | Investigational Site Number 840028 | Bloomfield Hills | Michigan |
United States | Investigational Site Number 840104 | Bradenton | Florida |
United States | Investigational Site Number 840112 | Bristol | Tennessee |
United States | Investigational Site Number 840057 | Butte | Montana |
United States | Investigational Site Number 840127 | Charleston | South Carolina |
United States | Investigational Site Number 840040 | Chesapeake | Virginia |
United States | Investigational Site Number 840024 | Chesterfield | Missouri |
United States | Investigational Site Number 840071 | Chesterfield | Michigan |
United States | Investigational Site Number 840026 | Chicago | Illinois |
United States | Investigational Site Number 840080 | Chicago | Illinois |
United States | Investigational Site Number 840116 | Chicago | Illinois |
United States | Investigational Site Number 840090 | Chino | California |
United States | Investigational Site Number 840002 | Chula Vista | California |
United States | Investigational Site Number 840004 | Columbus | Ohio |
United States | Investigational Site Number 840013 | Concord | California |
United States | Investigational Site Number 840066 | Corpus Christi | Texas |
United States | Investigational Site Number 840003 | Dallas | Texas |
United States | Investigational Site Number 840020 | Dallas | Texas |
United States | Investigational Site Number 840064 | Dallas | Texas |
United States | Investigational Site Number 840111 | Dallas | Texas |
United States | Investigational Site Number 840001 | Dearborn | Michigan |
United States | Investigational Site Number 840038 | Denver | Colorado |
United States | Investigational Site Number 840037 | Draper | Utah |
United States | Investigational Site Number 840088 | Edinburg | Texas |
United States | Investigational Site Number 840103 | Eugene | Oregon |
United States | Investigational Site Number 840031 | Evansville | Indiana |
United States | Investigational Site Number 840060 | Evansville | Indiana |
United States | Investigational Site Number 840082 | Evansville | Indiana |
United States | Investigational Site Number 840077 | Federal Way | Washington |
United States | Investigational Site Number 840118 | Fort Worth | Texas |
United States | Investigational Site Number 840053 | Fresno | California |
United States | Investigational Site Number 840049 | Greer | South Carolina |
United States | Investigational Site Number 840109 | Henderson | Nevada |
United States | Investigational Site Number 840021 | Hickory | North Carolina |
United States | Investigational Site Number 840055 | Houston | Texas |
United States | Investigational Site Number 840087 | Houston | Texas |
United States | Investigational Site Number 840079 | Hurst | Texas |
United States | Investigational Site Number 840108 | Idaho Falls | Idaho |
United States | Investigational Site Number 840048 | Indianapolis | Indiana |
United States | Investigational Site Number 840085 | Indianapolis | Indiana |
United States | Investigational Site Number 840091 | Kalamazoo | Michigan |
United States | Investigational Site Number 840094 | Knoxville | Tennessee |
United States | Investigational Site Number 840017 | La Jolla | California |
United States | Investigational Site Number 840070 | Lancaster | California |
United States | Investigational Site Number 840052 | Las Vegas | Nevada |
United States | Investigational Site Number 840054 | Lawrenceville | Georgia |
United States | Investigational Site Number 840022 | Lexington | Kentucky |
United States | Investigational Site Number 840084 | Little Rock | Arkansas |
United States | Investigational Site Number 840121 | Long Beach | California |
United States | Investigational Site Number 840044 | Los Angeles | California |
United States | Investigational Site Number 840126 | Los Angeles | California |
United States | Investigational Site Number 840007 | Louisville | Kentucky |
United States | Investigational Site Number 840016 | Maumee | Ohio |
United States | Investigational Site Number 840098 | Miami | Florida |
United States | Investigational Site Number 840033 | Milwaukee | Wisconsin |
United States | Investigational Site Number 840009 | Minneapolis | Minnesota |
United States | Investigational Site Number 840101 | Mission Hills | California |
United States | Investigational Site Number 840086 | Mission Viejo | California |
United States | Investigational Site Number 840120 | Mission Viejo | California |
United States | Investigational Site Number 840046 | Morehead City | North Carolina |
United States | Investigational Site Number 840072 | Morganton | North Carolina |
United States | Investigational Site Number 840123 | Morganville | New Jersey |
United States | Investigational Site Number 840073 | N Richland Hill | Texas |
United States | Investigational Site Number 840069 | Nashua | New Hampshire |
United States | Investigational Site Number 840030 | New Hyde Park | New York |
United States | Investigational Site Number 840081 | New Orleans | Louisiana |
United States | Investigational Site Number 840014 | New Port Richey | Florida |
United States | Investigational Site Number 840045 | Norfolk | Virginia |
United States | Investigational Site Number 840092 | Norfolk | Virginia |
United States | Investigational Site Number 840005 | Northridge | California |
United States | Investigational Site Number 840047 | Ocoee | Florida |
United States | Investigational Site Number 840093 | Ogden | Utah |
United States | Investigational Site Number 840042 | Omaha | Nebraska |
United States | Investigational Site Number 840056 | Palm Harbor | Florida |
United States | Investigational Site Number 840034 | Palm Springs | California |
United States | Investigational Site Number 840027 | Phoenix | Arizona |
United States | Investigational Site Number 840122 | Phoenix | Arizona |
United States | Investigational Site Number 840036 | Pittsburgh | Pennsylvania |
United States | Investigational Site Number 840074 | Port Hueneme | California |
United States | Investigational Site Number 840113 | Portland | Oregon |
United States | Investigational Site Number 840114 | Rapid City | South Dakota |
United States | Investigational Site Number 840102 | Renton | Washington |
United States | Investigational Site Number 840125 | Richmond | Virginia |
United States | Investigational Site Number 840063 | Rockville | Maryland |
United States | Investigational Site Number 840115 | Salem | Virginia |
United States | Investigational Site Number 840110 | Salisbury | North Carolina |
United States | Investigational Site Number 840041 | Salt Lake City | Utah |
United States | Investigational Site Number 840061 | Salt Lake City | Utah |
United States | Investigational Site Number 840019 | San Antonio | Texas |
United States | Investigational Site Number 840068 | San Ramon | California |
United States | Investigational Site Number 840067 | Santa Ana | California |
United States | Investigational Site Number 840050 | Springfield | Illinois |
United States | Investigational Site Number 840096 | Syracuse | New York |
United States | Investigational Site Number 840029 | Tarzana | California |
United States | Investigational Site Number 840006 | Temecula | California |
United States | Investigational Site Number 840023 | Tempe | Arizona |
United States | Investigational Site Number 840062 | Tempe | Arizona |
United States | Investigational Site Number 840043 | Tipton | Pennsylvania |
United States | Investigational Site Number 840012 | Valparaiso | Indiana |
United States | Investigational Site Number 840025 | Waterloo | Iowa |
United States | Investigational Site Number 840010 | Weber City | Virginia |
United States | Investigational Site Number 840078 | West Hills | California |
United States | Investigational Site Number 840095 | Wilmington | North Carolina |
United States | Investigational Site Number 840099 | Winston-Salem | North Carolina |
United States | Investigational Site Number 840119 | Woodstock | Georgia |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Australia, Belgium, Canada, Chile, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c from baseline | week 30 | No | |
Secondary | Percentage of patients reaching HbA1c targets | week 30 | No | |
Secondary | Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline | week 30 | No | |
Secondary | Change in body weight from baseline | week 30 | No | |
Secondary | Change in 7-point Self Measured Plasma Glucose profiles from baseline | week 30 | No | |
Secondary | Daily dose of insulin glargine | week 30 | No | |
Secondary | Change in Fasting Plasma Glucose from baseline | week 30 | No | |
Secondary | Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia | week 30 | Yes | |
Secondary | Severe symptomatic hypoglycemia | week 30 | Yes |
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