ClinConnect ClinConnect Logo
Search / Trial NCT01683266

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 24, 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.

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

0 patients applied

Trial Officials

Clinical Sciences & Operations

Study Director

Sanofi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials