Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Launched by SANOFI · Sep 10, 2012
Trial Information
Current as of July 27, 2025
Completed
Keywords
ClinConnect Summary
The maximum study duration was up to approximately 54 weeks per participants:
* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Adult participants with type 1 diabetes mellitus
- Exclusion criteria:
- • HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening
- • Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
- • Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
- • Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
- • Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
- • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
- • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
- • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period
- • 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
Chandler, Arizona, United States
Little Rock, Arkansas, United States
Bell Gardens, California, United States
Escondido, California, United States
Fresno, California, United States
Greenbrae, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Mesa, California, United States
La Mesa, California, United States
Long Beach, California, United States
Mission Hills, California, United States
Temecula, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Oviedo, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
Springfield, Illinois, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Haverhill, Massachusetts, United States
Detroit, Michigan, United States
Madison Heights, Michigan, United States
St Louis Park, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
New Hyde Park, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Morganton, North Carolina, United States
Mentor, Ohio, United States
Norman, Oklahoma, United States
Bend, Oregon, United States
Greer, South Carolina, United States
Dakota Dunes, South Dakota, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Murray, Utah, United States
Burke, Virginia, United States
Chesapeake, Virginia, United States
Manassas, Virginia, United States
Renton, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Milwaukee, Wisconsin, United States
Coquitlam, , Canada
Laval, , Canada
Mirabel, , Canada
Montreal, , Canada
Thornhill, , Canada
Toronto, , Canada
Brno, , Czech Republic
Praha 10, , Czech Republic
Praha 8, , Czech Republic
Esbjerg, , Denmark
Gentofte, , Denmark
København Nv, , Denmark
Køge, , Denmark
ålborg, , Denmark
Pärnu, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Tartu, , Estonia
Viljandimaa, , Estonia
Kokkola, , Finland
Kuopio, , Finland
Loimaa, , Finland
Oulu, , Finland
Tampere, , Finland
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Urhida, , Hungary
Aisai Shi, , Japan
Ise Shi, , Japan
Karatsu Shi, , Japan
Kitakyushu Shi, , Japan
Matsumoto Shi, , Japan
Matumoto, , Japan
Midori Shi, , Japan
Mito Shi, , Japan
Sakai Shi, , Japan
Tomishiro, , Japan
Yamagata Shi, , Japan
Limbazi, , Latvia
Riga, , Latvia
Riga, , Latvia
Sigulda, , Latvia
Ventspils, , Latvia
Almere, , Netherlands
Beek, , Netherlands
Nijmegen, , Netherlands
Venlo, , Netherlands
Zwijndrecht, , Netherlands
Ponce, , Puerto Rico
Bacau, , Romania
Brasov, , Romania
Oradea, , Romania
Resita, , Romania
Sibiu, , Romania
Targu Mures, , Romania
Targu Mures, , Romania
Timisoara, , Romania
Timisoara, , Romania
Goteborg, , Sweden
Kristianstad, , Sweden
Stockholm, , Sweden
Vällingby, , Sweden
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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