Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Launched by SANOFI · Dec 21, 2011
Trial Information
Current as of August 20, 2025
Completed
Keywords
ClinConnect Summary
The maximum study duration was up to approximately 58 weeks per participants, consisting of:
* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300
Gender
ALL
Eligibility criteria
- Inclusion criteria :
- • Participants with type 2 diabetes mellitus
- * Substudy inclusion criteria:
- • Completion of the 6-month study period in main study (Visit 10)
- • Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6)
- Exclusion criteria:
- • Age less than (\<) 18 years
- • HbA1c \<7.0% or greater than (\>) 10% at screening
- • Diabetes other than type 2 diabetes mellitus
- • Less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
- • Participants using sulfonylurea in the last 2 months before screening visit
- • Any contraindication to use of insulin glargine as defined in the national product label
- • Use of insulin pump in the last 6 months before screening
- • Initiation of new glucose-lowering medications in the last 3 months before screening visit
- • History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period
- • Pregnant or breast-feeding women or women who intend to become pregnant during the study period
- * Substudy exclusion criteria:
- • Participant not willing to use the adaptable injection intervals on at least two days per week
- • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rapid City, South Dakota, United States
Johannesburg, , South Africa
Santiago, , Chile
Dallas, Texas, United States
St Petersburg, , Russian Federation
Bloemfontein, , South Africa
Moscow, , Russian Federation
Daytona Beach, Florida, United States
Avon, Indiana, United States
Beamsville, , Canada
Burlington, , Canada
Calgary, , Canada
Coquitlam, , Canada
Hamilton, , Canada
Red Deer, , Canada
Toronto, , Canada
Victoria, , Canada
Winnipeg, , Canada
Helsinki, , Finland
Budapest, , Hungary
Monterrey, , Mexico
Pachuca, , Mexico
Birmingham, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tempe, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Mountain Home, Arkansas, United States
Searcy, Arkansas, United States
Anaheim, California, United States
Bell Gardens, California, United States
Greenbrae, California, United States
La Jolla, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Santa Barbara, California, United States
Tustin, California, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Brandon, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Columbus, Georgia, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Mchenry, Illinois, United States
Springfield, Illinois, United States
Avon, Indiana, United States
Avon, Indiana, United States
Avon, Indiana, United States
Avon, Indiana, United States
Evansville, Indiana, United States
Lafayette, Indiana, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Ann Arbor, Michigan, United States
Dearborn, Michigan, United States
Flint, Michigan, United States
Southfield, Michigan, United States
Eagan, Minnesota, United States
Minneapolis, Minnesota, United States
Biloxi, Mississippi, United States
Chesterfield, Missouri, United States
Butte, Montana, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Summit, New Jersey, United States
Toms River, New Jersey, United States
Toms River, New Jersey, United States
Calabash, North Carolina, United States
Hickory, North Carolina, United States
Hickory, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Maumee, Ohio, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Tipton, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Williamsburg, Virginia, United States
Winchester, Virginia, United States
Olympia, Washington, United States
Walla Walla, Washington, United States
Milwaukee, Wisconsin, United States
Chilliwack, , Canada
Edmonton, , Canada
Mirabel, , Canada
Mississauga, , Canada
Sherbrooke, , Canada
Osorno, , Chile
Rancagua, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Valdivia, , Chile
La Rochelle Cedex, , France
Le Creusot, , France
Mantes La Jolie, , France
Nantes, , France
Strasbourg, , France
Venissieux, , France
Künzing, , Germany
Neumünster, , Germany
Oberhausen, , Germany
Pirna, , Germany
Rehlingen Siersburg, , Germany
Wangen, , Germany
Baja, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Eger, , Hungary
Makó, , Hungary
Mosonmagyaróvár, , Hungary
Pápa, , Hungary
Sátorlaljaújhely, , Hungary
Acapulco, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Matosinhos, , Portugal
Porto, , Portugal
Bacau, , Romania
Brasov, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Cluj Napoca, , Romania
Deva, , Romania
Hunedoara, , Romania
Iasi, , Romania
Oradea, , Romania
Ploiesti, , Romania
Resita, , Romania
Targu Mures, , Romania
Timisoara, , Romania
Timisoara, , Romania
Moscow, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
St Petersburg, , Russian Federation
St Petersburg, , Russian Federation
St Petersburg, , Russian Federation
St Petersburg, , Russian Federation
St Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Ufa, , Russian Federation
Voronezh, , Russian Federation
Benoni, , South Africa
Bloemfontein, , South Africa
Boksburg, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Pretoria, , South Africa
Somerset West, , South Africa
Umkomaas, , South Africa
Barcelona, , Spain
Malaga, , Spain
Palma De Mallorca, , Spain
Sabadell, , Spain
Sevilla, , Spain
Valancia, , Spain
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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