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

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - Any
Updated:	1/20/2018
Start Date:	October 2014
End Date:	July 2016

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

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)
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 participants
reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose
(SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

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 weeks per participant and a 1-day safety
follow-up

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.

We found this trial at

sites

Clinical Trial Facility in Tacoma Washington

Tacoma, Washington

from

Tacoma, WA