Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
Launched by SANOFI · Dec 21, 2011
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
The maximum study duration was up to approximately 58 weeks per participant, 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 1 year on basal plus mealtime insulin and self-monitoring of blood glucose
- • Any contraindication to use of insulin glargine as defined in the national product label
- • Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit
- • Use of an insulin pump in the last 6 months before screening visit
- • Initiation of new glucose-lowering agents and/or weight loss drugs 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
Montreal, , Canada
Dallas, Texas, United States
Oulu, , Finland
Oradea, , Romania
Tallinn, , Estonia
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
Searcy, Arkansas, United States
Anaheim, California, United States
Encino, California, United States
Greenbrae, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Mesa, California, United States
Mission Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Longmont, Colorado, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Lawrenceville, Georgia, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, 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
Avon, Indiana, United States
Vincennes, Indiana, United States
Des Moines, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, 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
Kalamazoo, Michigan, United States
Southfield, Michigan, United States
Chaska, Minnesota, United States
Eagan, Minnesota, United States
Minneapolis, Minnesota, United States
Kalispell, Montana, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Brick, New Jersey, United States
Toms River, New Jersey, United States
Asheville, North Carolina, United States
Hickory, North Carolina, United States
Wilmington, 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
Mentor, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Uniontown, Pennsylvania, United States
Greer, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
Draper, Utah, United States
Ogden, Utah, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Norfolk, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Williamsburg, Virginia, United States
Milwaukee, Wisconsin, United States
Beamsville, , Canada
Burlington, , Canada
Calgary, , Canada
Calgary, , Canada
Chatham, , Canada
Coquitlam, , Canada
Hamilton, , Canada
Hamilton, , Canada
Laval, , Canada
London, , Canada
Mississauga, , Canada
Montreal, , Canada
Oshawa, , Canada
Quebec, , Canada
Red Deer, , Canada
Thornhill, , Canada
Toronto, , Canada
Toronto, , Canada
Victoria, , Canada
Ville St Laurent, , Canada
Winnipeg, , Canada
Beroun, , Czechia
Breclav, , Czechia
Hodonin, , Czechia
Holesov, , Czechia
Hradec Kralove, , Czechia
Hranice, , Czechia
Krnov, , Czechia
Olomouc, , Czechia
Praha 2, , Czechia
Prostejov, , Czechia
Pärnu, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Helsinki, , Finland
Kuopio, , Finland
La Rochelle Cedex, , France
Strasbourg, , France
Heidelberg, , Germany
Riesa, , Germany
Schwabenheim, , Germany
Baja, , Hungary
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gyula, , Hungary
Makó, , Hungary
Mosonmagyaróvár, , Hungary
Nyiregyháza, , Hungary
Szeged, , Hungary
Szombathely, , Hungary
Sátorlaljaújhely, , Hungary
Zalaegerszeg, , Hungary
Jekabpils, , Latvia
Ogre, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Sigulda, , Latvia
Chihuahua, , Mexico
Cuernavaca, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Pachuca, , Mexico
Almelo, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Hoogeveen, , Netherlands
Hoorn, , Netherlands
Leeuwarden, , Netherlands
Utrecht, , Netherlands
Venlo, , Netherlands
Bacau, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Cluj Napoca, , Romania
Iasi, , Romania
Iasi, , Romania
Targu Mures, , Romania
Timisoara, , Romania
Alberton, , South Africa
Johannesburg, , South Africa
Lenasia, , South Africa
Observatory, , South Africa
Paarl, , South Africa
Pretoria, , South Africa
Somerset West, , South Africa
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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