Clinical Trial Details

NCT ID: NCT03211858
Date Last Changed: September 14, 2017

Overview

Research Study Summary

A Phase 3 clinical study for patients with Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Research Study Title

Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Also Using Insulin Glargine, With a 6-month Safety Extension Period

Purpose

Primary Objective:

To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.

Secondary Objectives:

  • To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study.

  • To assess the relationship of AIAs with efficacy and safety.

  • To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of patients reaching HbA1c <7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c).

  • To assess safety of SAR341402 and NovoLog/NovoRapid.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi
Duration
17 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion criteria :

  • Patients with T1DM or T2DM diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with

  • NovoLog/NovoRapid OR insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND

  • insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit.

Exclusion criteria:

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

  • Glycated hemoglobin (HbA1c) < 7.0% or > 10% at screening

  • Less than 1 year on continuous insulin treatment.

  • Use of insulin pump in the last 3 months before screening visit

  • Patients with incomplete baseline 7-point SMPG profile, defined as patients who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.

  • Patients with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.

  • Patients with T2DM:

  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit;

  • Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas will be discontinued at baseline).

  • At screening visit, body mass index (BMI) ≥35 kg/m2 in patients with T1DM and ≥40 kg/m2 in patients with T2DM.

  • Use of insulin other than:

  • insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR

  • insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen.

  • Status post pancreatectomy.

  • Status post pancreas and/or islet cell transplantation.

  • Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.

  • History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 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.

  • Pregnant or breastfeeding women.

  • Women of childbearing potential not protected by highly effective method(s) of birth control.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Site Locations (45)

Country State City Zip Facility and Contact
United States Arkansas Little Rock 72205 Investigational Site Number 8400040
United States California Concord 94520 Investigational Site Number 8400012
United States California Escondido 92025 Investigational Site Number 8400002
United States California Fresno 93720 Investigational Site Number 8400030
United States California Greenbrae 94904 Investigational Site Number 8400004
United States California La Jolla 92037 Investigational Site Number 8400014
United States California Los Angeles 90057 Investigational Site Number 8400043
United States California Pomona 91766 Investigational Site Number 8400036
United States California Santa Barbara 93105 Investigational Site Number 8400011
United States California Ventura 93003 Investigational Site Number 8400013
United States Colorado Aurora 80045 Investigational Site Number 8400037
United States Colorado Englewood 80113 Investigational Site Number 8400018
United States Florida New Port Richey 34652 Investigational Site Number 8400031
United States Florida Ocoee 34761 Investigational Site Number 8400027
United States Georgia Atlanta 30318 Investigational Site Number 8400007
United States Georgia Columbus 31904 Investigational Site Number 8400022
United States Georgia Roswell 30076 Investigational Site Number 8400032
United States Illinois Arlington Heights 60005 Investigational Site Number 8400038
United States Iowa Des Moines 50314 Investigational Site Number 8400005
United States Louisiana Metairie 70006 Investigational Site Number 8400041
United States Maryland Rockville 20852-4267 Investigational Site Number 8400015
United States Massachusetts Waltham 02453 Investigational Site Number 8400042
United States Michigan Flint 48532-3447 Investigational Site Number 8400019
United States Nebraska Omaha 68131 Investigational Site Number 8400003
United States Nevada Henderson 89052 Investigational Site Number 8400024
United States New York New York 10001 Investigational Site Number 8400028
United States North Carolina Morehead City 28557 Investigational Site Number 8400025
United States North Carolina Wilmington 28401 Investigational Site Number 8400010
United States North Dakota Fargo 58103 Investigational Site Number 8400023
United States Oregon Bend 97701 Investigational Site Number 8400029
United States Tennessee Chattanooga 37404 Investigational Site Number 8400033
United States Texas Austin 78731 Investigational Site Number 8400044
United States Texas Dallas 75230 Investigational Site Number 8400009
United States Texas Dallas 75230 Investigational Site Number 8400035
United States Texas Dallas 75246 Investigational Site Number 8400021
United States Texas Houston 77043 Investigational Site Number 8400017
United States Texas Houston 77079 Investigational Site Number 8400001
United States Texas Houston 77089 Investigational Site Number 8400020
United States Texas Mesquite 75149 Investigational Site Number 8400016
United States Utah Salt Lake City 84102 Investigational Site Number 8400034
United States Washington Renton 98057 Investigational Site Number 8400008
United States West Virginia Bridgeport 26330 Investigational Site Number 8400039
Japan Fukuyama-Shi Investigational Site Number 3920009
Japan Sagamihara-Shi Investigational Site Number 3920002
Japan Shinjuku-Ku Investigational Site Number 3920004

Contact

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