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Status:

COMPLETED

Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Lead Sponsor:

Sanofi

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) a...

Detailed Description

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period. The maximum study duration will then be 28 weeks per participant and a 1-day safety ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
  • Signed written informed consent.
  • Exclusion criteria:
  • At screening visit, age under legal age of adulthood.
  • HbA1c \<6.5% or \>10.0% at screening.
  • Diabetes other than T2DM.
  • Pregnancy and lactation.
  • Women of childbearing potential not protected by highly effective contraceptive method of birth control.
  • Use of insulin pump in the 6 months before screening visit.
  • Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
  • Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
  • Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
  • Body mass index (BMI) \>=40kg/m² at screening visit.
  • 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 :

    January 1 2015

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2016

    Estimated Enrollment :

    505 Patients enrolled

    Trial Details

    Trial ID

    NCT02294474

    Start Date

    January 1 2015

    End Date

    February 1 2016

    Last Update

    January 18 2018

    Active Locations (103)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 26 (103 locations)

    1

    Investigational Site Number 840217

    Foley, Alabama, United States, 36535

    2

    Investigational Site Number 840237

    Muscle Shoals, Alabama, United States, 35661

    3

    Investigational Site Number 840245

    Chandler, Arizona, United States

    4

    Investigational Site Number 840219

    Phoenix, Arizona, United States, 85028