Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine - Full Text View

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.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus	Drug: SAR341402 Drug: insulin aspart Drug: insulin glargine (HOE901)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

Drug Information available for: Insulin Insulin human Insulin aspart Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Change in glycated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 26 ]
Change in HbA1c (%) from baseline to Week 26

Secondary Outcome Measures:

Change in HbA1c [ Time Frame: Baseline to Week 52 ]
Change in HbA1c(%) from baseline to Week 52
Patients with HbA1c <7% [ Time Frame: At Week 26, Week 52 ]
The percentage of patients with HbA1c <7 % at Week 26 and Week 52
Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 26, Week 52 ]
Change from baseline in FPG at Week 26 and Week 52
Change in mean 24-hour plasma glucose concentration [ Time Frame: Baseline to Week 26, Week 52 ]
Change from baseline in the mean 24-hour plasma glucose concentration, based on the 7-point SMPG profiles at Week 26 and Week 52
Change in Postprandial Plasma Glucose (PPG) [ Time Frame: Baseline to Week 26, Week 52 ]
Change from baseline in postprandial plasma glucose excursions at breakfast, lunch and dinner, based on the 7-point SMPG profiles at Week 26 and Week 52
Change in 7-point self-monitored plasma glucose (SMPG) [ Time Frame: Baseline to Week 26, Week 52 ]
Change from baseline in 7-point SMPG profiles per time-point at Week 26 and Week 52
Hypoglycemic patients [ Time Frame: At Week 26, Week 52 ]
Number of patients with hypoglycemia event at Week 26 and Week 52
Hypoglycemic events [ Time Frame: At Week 26, Week 52 ]
Number of hypoglycemia events per patient at Week 26 and Week 52
Anti-SAR341402/NovoLog/NovoRapid antibody status [ Time Frame: At Week 26, Week 52 ]
Anti-SAR341402/NovoLog/NovoRapid antibody positive/negative status, titers and cross-reactivity to human insulin at each sampling visit up to Week 26, and during the extension period up to Week 52
Treatment-induced, treatment-boosted and treatment-emergent AIAs [ Time Frame: At Week 26, Week 52 ]
Treatment-induced, treatment-boosted and treatment-emergent anti-insulin antibodies (AIAs) during the main 6-month and the 12-month on-treatment periods.


Estimated Enrollment:	500
Anticipated Study Start Date:	August 2, 2017
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SAR341402 Given subcutaneously (SC) immediately before all meals and snacks as mealtime rapid acting insulin on top of glargine as the basal insulin.	Drug: SAR341402 Pharmaceutical form: solution Route of administration: subcutaneous Drug: insulin glargine (HOE901) Pharmaceutical form: solution Route of administration: subcutaneous Other Name: Lantus
Active Comparator: NovoLog/NovoRapid Given SC immediately before all meals and snacks as mealtime rapid acting insulin on top of glargine as the basal insulin.	Drug: insulin aspart Pharmaceutical form: solution Route of administration: subcutaneous Other Name: NovoLog/NovoRapid Drug: insulin glargine (HOE901) Pharmaceutical form: solution Route of administration: subcutaneous Other Name: Lantus

Detailed Description:

The study will consist of a screening period up to 2 weeks, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration will then be 54 weeks per patient and a 1 day safety follow-up.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211858

Contacts


Contact: Trial Transparency email recommended (Toll free number for US & Canada)	800-633-1610 ext 1 then #	Contact-US@sanofi.com

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Clinical Sciences & Operations	Sanofi

More Information


Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT03211858 History of Changes
Other Study ID Numbers:	EFC15081 2017-000091-28 ( EudraCT Number ) U1111-1191-5775 ( Other Identifier: UTN )
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
URL:	http://


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases	Insulin, Globin Zinc Insulin degludec, insulin aspart drug combination Insulin Insulin Glargine Insulin Aspart Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 11, 2017

Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI 1)