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Search / Trial NCT01499095

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.

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

0 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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