Status:
COMPLETED
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) ...
Detailed Description
The study consisted 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 would be 54 w...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants with T1DM diagnosed for at least 12 months and had 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 participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT02273180
Start Date
October 1 2014
End Date
July 1 2016
Last Update
January 18 2018
Active Locations (89)
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1
Investigational Site Number 840049
Tucson, Arizona, United States, 85714
2
Investigational Site Number 840016
Bell Gardens, California, United States, 90201
3
Investigational Site Number 840048
Chula Vista, California, United States, 91910
4
Investigational Site Number 840046
Concord, California, United States, 94520