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

Use our guide to learn which trials are right for you!

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
49
sites
North Miami Beach, Florida 33162
2319
mi
from 91732
North Miami Beach, FL
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
10
mi
from 91732
Bell Gardens, CA
Click here to add this to my saved trials
2140
mi
from 91732
Bradenton, FL
Click here to add this to my saved trials
Burlington, North Carolina 27215
2171
mi
from 91732
Burlington, NC
Click here to add this to my saved trials
2340
mi
from 91732
Chesapeake, VA
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
113
mi
from 91732
Chula Vista, CA
Click here to add this to my saved trials
1161
mi
from 91732
Concord, CA
Click here to add this to my saved trials
9
mi
from 91732
Corbeil Essonnes,
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
1299
mi
from 91732
Dakota Dunes, SD
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
1422
mi
from 91732
Des Moines, IA
Click here to add this to my saved trials
207
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
2002
mi
from 91732
Gallipolis, OH
Click here to add this to my saved trials
991
mi
from 91732
Great Falls, MT
Click here to add this to my saved trials
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
725
mi
from 91732
Idaho Falls, ID
Click here to add this to my saved trials
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
1655
mi
from 91732
Marrero, LA
Click here to add this to my saved trials
1703
mi
from 91732
Mchenry, IL
Click here to add this to my saved trials
1648
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
?
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
?
mi
from 91732
Miami Lakes, FL
Click here to add this to my saved trials
1722
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
2451
mi
from 91732
Mineola, NY
Click here to add this to my saved trials
2114
mi
from 91732
New Port Richey, FL
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2180
mi
from 91732
Port Charlotte, FL
Click here to add this to my saved trials
1049
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
2275
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
1919
mi
from 91732
Roswell, GA
Click here to add this to my saved trials
939
mi
from 91732
Tacoma, WA
Click here to add this to my saved trials
427
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
70
mi
from 91732
Ventura, CA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
2275
mi
from 91732
Wilmington, NC
Click here to add this to my saved trials