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Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: SAR342434 (Drug); insulin lispro (Drug); insulin glargine HOE901 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Summary

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in HbA1c change in patients with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of patients reaching target HbA1c (<7%) and on fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Clinical Details

Official title: Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c from baseline

Secondary outcome:

Percentage of patients with HbA1c <7%

Change in FPG from baseline

Change in the mean 24-hour plasma glucose concentration, based on the 7-point self measured plasma glucose profile from baseline

Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) from baseline

Number of patients with hypoglycemia event

Number of hypoglycemia events per patient

Detailed description: The study will consist of a:

- Up to 2 weeks screening period

- 26-week treatment period

- 26-week comparative safety extension period

- 1-day follow-up period.

- The maximum study duration will then be 54 weeks per patient and a 1-day safety

follow-up.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients with T1DM diagnosed for at least 12 months and have been treated with

insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.

- Written informed consent.

Exclusion criteria:

- At screening visit, age under legal age of adulthood.

- HbA1c <7. 0% or >10% at screening.

- Diabetes other than T1DM.

- Status post pancreatectomy.

- Status post pancreas and/or islet cell transplantation.

- Pregnancy and lactation.

- Women of childbearing potential not protected by highly effective contraceptive

method of birth control.

- Less than 1 year on continuous insulin treatment.

- Use of insulin pump in the last 6 months before screening visit.

- Use of glucose lowering treatments other than insulin including non-insulin

injectable peptides in the last 6 months prior to screening visit.

- Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part

of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.

- 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 (eg, laser, surgical treatment, or injectable drugs) during the study period. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Investigational Site Number 250002, Corbeil Essonnes 91109, France

Investigational Site Number 250005, Mantes La Jolie 78200, France

Investigational Site Number 250003, Montpellier Cedex 5 34295, France

Investigational Site Number 250001, Vandoeuvre Les Nancy 54511, France

Investigational Site Number 276001, Berlin 10115, Germany

Investigational Site Number 276004, Dortmund 44137, Germany

Investigational Site Number 276006, Hannover 30159, Germany

Investigational Site Number 276002, Heidelberg 69115, Germany

Investigational Site Number 276003, NeumĂĽnster 24534, Germany

Investigational Site Number 276008, Pirna 01796, Germany

Investigational Site Number 276007, Potsdam 14469, Germany

Investigational Site Number 276005, Sulzbach-Rosenberg 92237, Germany

Investigational Site Number 348001, Budapest 1213, Hungary

Investigational Site Number 348002, Budapest 1023, Hungary

Investigational Site Number 348003, Budapest 1134, Hungary

Investigational Site Number 348005, Budapest 1033, Hungary

Investigational Site Number 348010, Budapest 1139, Hungary

Investigational Site Number 348011, Budapest 1062, Hungary

Investigational Site Number 348007, Debrecen 4031, Hungary

Investigational Site Number 392006, Chuo-Ku, Japan

Investigational Site Number 392003, Higashiosaka-Shi, Japan

Investigational Site Number 392004, Izumisano-Shi, Japan

Investigational Site Number 392005, Kamakura-Shi, Japan

Investigational Site Number 392001, Shinjuku-Ku, Japan

Investigational Site Number 392002, Yamato-Shi, Japan

Investigational Site Number 616005, Krakow 31-501, Poland

Investigational Site Number 616001, Poznan 60-834, Poland

Investigational Site Number 616003, Szczecin 70-506, Poland

Investigational Site Number 616002, Warszawa 02-507, Poland

Investigational Site Number 616004, Zabrze 41-800, Poland

Investigational Site Number 643003, Moscow 117036, Russian Federation

Investigational Site Number 643006, Samara 443067, Russian Federation

Investigational Site Number 643002, Saratov 410030, Russian Federation

Investigational Site Number 643001, St-Petersburg 194354, Russian Federation

Investigational Site Number 643004, St-Petersburg 190068, Russian Federation

Investigational Site Number 643005, St-Petersburg 195257, Russian Federation

Investigational Site Number 643007, Tomsk 634050, Russian Federation

Investigational Site Number 724001, Cáceres 10003, Spain

Investigational Site Number 724002, La Coruña 15006, Spain

Investigational Site Number 724004, LĂ©rida 25198, Spain

Investigational Site Number 724005, Málaga 29010, Spain

Investigational Site Number 724003, Sabadell 08208, Spain

Investigational Site Number 840049, Tucosn, Arizona 85714, United States

Investigational Site Number 840016, Bell Gardens, California 90201, United States

Investigational Site Number 840048, Chula Vista, California 91911, United States

Investigational Site Number 840046, Concord, California 94520, United States

Investigational Site Number 840039, Fresno, California 93720, United States

Investigational Site Number 840028, La Jolla, California 92037, United States

Investigational Site Number 840022, Ventura, California 93003, United States

Investigational Site Number 840003, Denver, Colorado 80209, United States

Investigational Site Number 840037, Denver, Colorado 80262, United States

Investigational Site Number 840005, Bradenton, Florida 34208, United States

Investigational Site Number 840057, Miami Lakes, Florida 33016, United States

Investigational Site Number 840061, Miami Lakes, Florida 33014, United States

Investigational Site Number 840042, Miami, Florida 33176, United States

Investigational Site Number 840050, Miami, Florida 33155, United States

Investigational Site Number 840006, New Port Richey, Florida 34652, United States

Investigational Site Number 840013, North Miami Beach, Florida 33162, United States

Investigational Site Number 840031, Port Charlotte, Florida 33952, United States

Investigational Site Number 840036, Atlanta, Georgia 30318, United States

Investigational Site Number 840045, Roswell, Georgia 30076, United States

Investigational Site Number 840020, Idaho Falls, Idaho 83404, United States

Investigational Site Number 840019, Chicago, Illinois 60607, United States

Investigational Site Number 840033, Chicago, Illinois 60612, United States

Investigational Site Number 840012, Mchenry, Illinois 60050, United States

Investigational Site Number 840004, Des Moines, Iowa 50314, United States

Investigational Site Number 840043, Marrero, Louisiana 70072, United States

Investigational Site Number 840021, Metairie, Louisiana 70006, United States

Investigational Site Number 840044, Monroe, Louisiana 71201, United States

Investigational Site Number 840038, Baltimore, Maryland 21237, United States

Investigational Site Number 840014, Rockville, Maryland 20852, United States

Investigational Site Number 840060, Great Falls, Montana 59405, United States

Investigational Site Number 840026, Omaha, Nebraska 68114, United States

Investigational Site Number 840040, Omaha, Nebraska 68131, United States

Investigational Site Number 840015, Albuquerque, New Mexico 87106, United States

Investigational Site Number 840054, Albuquerque, New Mexico 87109, United States

Investigational Site Number 840059, Mineola, New York 11501, United States

Investigational Site Number 840030, Burlington, North Carolina 27215, United States

Investigational Site Number 840051, Greenville, North Carolina 27834, United States

Investigational Site Number 840062, Wilmington, North Carolina 28401, United States

Investigational Site Number 840018, Gallipolis, Ohio 45631, United States

Investigational Site Number 840007, Dakota Dunes, South Dakota 57049, United States

Investigational Site Number 840027, Rapid City, South Dakota 57701, United States

Investigational Site Number 840029, Dallas, Texas 75231, United States

Investigational Site Number 840034, Dallas, Texas 75246, United States

Investigational Site Number 840041, Dallas, Texas 75230, United States

Investigational Site Number 840002, Houston, Texas 77090, United States

Investigational Site Number 840011, Chesapeake, Virginia 23321, United States

Investigational Site Number 840023, Tacoma, Washington 98415-0299, United States

Investigational Site Number 840009, Milwaukee, Wisconsin 53209-0996, United States

Additional Information

Starting date: October 2014
Last updated: June 17, 2015

Page last updated: August 23, 2015

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