A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT02688933

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 638 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-05
• Study Completion Date: 2017-06-19

Brief Summary

Primary Objective:

To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.

Secondary Objective:

To demonstrate that treatment with HOE901-U300 compared to Lantus provides:

• Lower incidence rate of nocturnal symptomatic hypoglycemia;
• Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
• Less variability in CGM profile.

Detailed Description

The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOE901-U300

HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

Group Type: EXPERIMENTAL

HOE901-U300 (Insulin Glargine 300 U/ml)

Intervention Type: DRUG

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.

Mandated back ground therapy

Intervention Type: DRUG

Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Lantus

Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

Group Type: ACTIVE_COMPARATOR

Lantus (Insulin Glargine 100 U/ml)

Intervention Type: DRUG

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.

Mandated back ground therapy

Intervention Type: DRUG

Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Interventions

HOE901-U300 (Insulin Glargine 300 U/ml)

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.

Intervention Type: DRUG

Lantus (Insulin Glargine 100 U/ml)

Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.

Intervention Type: DRUG

Mandated back ground therapy

Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Intervention Type: DRUG

Other Intervention Names

Toujeo; HOE901-U100

Eligibility Criteria

Inclusion Criteria

• Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
• Signed written informed consent.

Exclusion Criteria

• Age <18 years or >70 years.
• Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
• Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
• Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.
• Participants who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
• Participants received less than 1 year treatment with basal plus mealtime insulin.
• Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
• Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
• Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
• Used human regular insulin as mealtime insulin within 30 days prior to screening.
• Used an insulin pump during the last 6 months before screening.
• History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
• Pregnant or breast-feeding women or planned pregnancy during the duration of the study.
• Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.
• Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
• Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840-151

Little Rock, Arkansas, United States

Investigational Site Number 840-071

Concord, California, United States

Investigational Site Number 840-149

Escondido, California, United States

Investigational Site Number 840-004

Fresno, California, United States

Investigational Site Number 840-110

Greenbrae, California, United States

Investigational Site Number 840-124

La Jolla, California, United States

Investigational Site Number 840-030

La Mesa, California, United States

Investigational Site Number 840-044

Los Angeles, California, United States

Investigational Site Number 840-022

Los Angeles, California, United States

Investigational Site Number 840-129

Los Gatos, California, United States

Investigational Site Number 840-024

Northridge, California, United States

Investigational Site Number 840-069

Pomona, California, United States

Investigational Site Number 840-090

Pomona, California, United States

Investigational Site Number 840-132

Rolling Hills Estates, California, United States

Investigational Site Number 840-130

San Jose, California, United States

Investigational Site Number 840-055

San Ramon, California, United States

Investigational Site Number 840-028

Santa Barbara, California, United States

Investigational Site Number 840-063

Tarzana, California, United States

Investigational Site Number 840-138

Tustin, California, United States

Investigational Site Number 840-016

Ventura, California, United States

Investigational Site Number 840-039

Denver, Colorado, United States

Investigational Site Number 840-021

Denver, Colorado, United States

Investigational Site Number 840-070

Denver, Colorado, United States

Investigational Site Number 840-046

Englewood, Colorado, United States

Investigational Site Number 840-072

Coral Gables, Florida, United States

Investigational Site Number 840-133

Hialeah, Florida, United States

Investigational Site Number 840-137

Maitland, Florida, United States

Investigational Site Number 840-049

Miami, Florida, United States

Investigational Site Number 840-076

Miami, Florida, United States

Investigational Site Number 840-023

New Port Richey, Florida, United States

Investigational Site Number 840-053

Ocoee, Florida, United States

Investigational Site Number 840-112

Ormond Beach, Florida, United States

Investigational Site Number 840-018

Palm Harbor, Florida, United States

Investigational Site Number 840-047

Port Charlotte, Florida, United States

Investigational Site Number 840-114

Tampa, Florida, United States

Investigational Site Number 840-036

West Palm Beach, Florida, United States

Investigational Site Number 840-001

Atlanta, Georgia, United States

Investigational Site Number 840-064

Columbus, Georgia, United States

Investigational Site Number 840-012

Lawrenceville, Georgia, United States

Investigational Site Number 840-008

Roswell, Georgia, United States

Investigational Site Number 840-014

Stockbridge, Georgia, United States

Investigational Site Number 840-060

Idaho Falls, Idaho, United States

Investigational Site Number 840-125

Arlington Heights, Illinois, United States

Investigational Site Number 840-011

Chicago, Illinois, United States

Investigational Site Number 840-134

Crystal Lake, Illinois, United States

Investigational Site Number 840-002

West Des Moines, Iowa, United States

Investigational Site Number 840-073

Wichita, Kansas, United States

Investigational Site Number 840-062

Covington, Kentucky, United States

Investigational Site Number 840-042

Lexington, Kentucky, United States

Investigational Site Number 840-009

Metairie, Louisiana, United States

Investigational Site Number 840-032

New Orleans, Louisiana, United States

Investigational Site Number 840-054

Hyattsville, Maryland, United States

Investigational Site Number 840-006

Rockville, Maryland, United States

Investigational Site Number 840-157

Framingham, Massachusetts, United States

Investigational Site Number 840-122

Waltham, Massachusetts, United States

Investigational Site Number 840-037

Flint, Michigan, United States

Investigational Site Number 840-067

Billings, Montana, United States

Investigational Site Number 840-094

Lincoln, Nebraska, United States

Investigational Site Number 840-033

Omaha, Nebraska, United States

Investigational Site Number 840-142

Omaha, Nebraska, United States

Investigational Site Number 840-040

Henderson, Nevada, United States

Investigational Site Number 840-017

Las Vegas, Nevada, United States

Investigational Site Number 840-102

New York, New York, United States

Investigational Site Number 840-108

New York, New York, United States

Investigational Site Number 840-109

Staten Island, New York, United States

Investigational Site Number 840-045

Greenville, North Carolina, United States

Investigational Site Number 840-010

Morehead City, North Carolina, United States

Investigational Site Number 840-080

Morehead City, North Carolina, United States

Investigational Site Number 840-051

Fargo, North Dakota, United States

Investigational Site Number 840-123

Columbus, Ohio, United States

Investigational Site Number 840-104

Mentor, Ohio, United States

Investigational Site Number 840-079

Norman, Oklahoma, United States

Investigational Site Number 840-162

Bend, Oregon, United States

Investigational Site Number 840-096

Portland, Oregon, United States

Investigational Site Number 840-058

Chattanooga, Tennessee, United States

Investigational Site Number 840-003

Dallas, Texas, United States

Investigational Site Number 840-019

Dallas, Texas, United States

Investigational Site Number 840-075

Dallas, Texas, United States

Investigational Site Number 840-005

Dallas, Texas, United States

Investigational Site Number 840-013

Dallas, Texas, United States

Investigational Site Number 840-153

El Paso, Texas, United States

Investigational Site Number 840-026

Fort Worth, Texas, United States

Investigational Site Number 840-081

Houston, Texas, United States

Investigational Site Number 840-160

Houston, Texas, United States

Investigational Site Number 840-156

Houston, Texas, United States

Investigational Site Number 840-152

Houston, Texas, United States

Investigational Site Number 840-031

Houston, Texas, United States

Investigational Site Number 840-140

Lufkin, Texas, United States

Investigational Site Number 840-029

Mesquite, Texas, United States

Investigational Site Number 840-048

North Richland Hills, Texas, United States

Investigational Site Number 840-150

Pearland, Texas, United States

Investigational Site Number 840-083

Murray, Utah, United States

Investigational Site Number 840-101

Ogden, Utah, United States

Investigational Site Number 840-097

Salt Lake City, Utah, United States

Investigational Site Number 840-143

Bennington, Vermont, United States

Investigational Site Number 840-056

Burlington, Vermont, United States

Investigational Site Number 840-015

Renton, Washington, United States

Investigational Site Number 840-074

Spokane, Washington, United States

Investigational Site Number 840-139

Bridgeport, West Virginia, United States

Investigational Site Number 840-111

Manatí, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1176-0936

Identifier Type: OTHER

Identifier Source: secondary_id

LPS14587

Identifier Type: -

Identifier Source: org_study_id