Clinical trial NCT02688933: A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Official title: A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM
timeFrame: During Week 15 and/or 16
Secondary outcomes:
measure: Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia
timeFrame: Baseline up to Week 16
measure: Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year
timeFrame: Baseline up to Week 16
measure: Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16
timeFrame: Baseline, during Week 15 and/or Week 16
measure: Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection
timeFrame: During Week 15 and/or Week 16
measure: Coefficient of Variation (CV%) in Mean CGM Glucose
timeFrame: During Week 15 and/or Week 16
Other outcomes:
measure: Change From Baseline in Daily Insulin Dose at Week 16
timeFrame: Baseline, Week 16
Locations:
city: Little Rock
country: United States
facility: Investigational Site Number 840-151
state: Arkansas
city: Concord
country: United States
facility: Investigational Site Number 840-071
state: California
city: Escondido
country: United States
facility: Investigational Site Number 840-149
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840-004
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840-110
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840-124
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840-030
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840-044
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840-022
state: California
city: Los Gatos
country: United States
facility: Investigational Site Number 840-129
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840-024
state: California
city: Pomona
country: United States
facility: Investigational Site Number 840-069
state: California
city: Pomona
country: United States
facility: Investigational Site Number 840-090
state: California
city: Rolling Hills Estates
country: United States
facility: Investigational Site Number 840-132
state: California
city: San Jose
country: United States
facility: Investigational Site Number 840-130
state: California
city: San Ramon
country: United States
facility: Investigational Site Number 840-055
state: California
city: Santa Barbara
country: United States
facility: Investigational Site Number 840-028
state: California
city: Tarzana
country: United States
facility: Investigational Site Number 840-063
state: California
city: Tustin
country: United States
facility: Investigational Site Number 840-138
state: California
city: Ventura
country: United States
facility: Investigational Site Number 840-016
state: California
city: Denver
country: United States
facility: Investigational Site Number 840-039
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840-021
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840-070
state: Colorado
city: Englewood
country: United States
facility: Investigational Site Number 840-046
state: Colorado
city: Coral Gables
country: United States
facility: Investigational Site Number 840-072
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840-133
state: Florida
city: Maitland
country: United States
facility: Investigational Site Number 840-137
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840-049
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840-076
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840-023
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840-053
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site Number 840-112
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840-018
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 840-047
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840-114
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 840-036
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840-001
state: Georgia
city: Columbus
country: United States
facility: Investigational Site Number 840-064
state: Georgia
city: Lawrenceville
country: United States
facility: Investigational Site Number 840-012
state: Georgia
city: Roswell
country: United States
facility: Investigational Site Number 840-008
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site Number 840-014
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840-060
state: Idaho
city: Arlington Heights
country: United States
facility: Investigational Site Number 840-125
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840-011
state: Illinois
city: Crystal Lake
country: United States
facility: Investigational Site Number 840-134
state: Illinois
city: West Des Moines
country: United States
facility: Investigational Site Number 840-002
state: Iowa
city: Wichita
country: United States
facility: Investigational Site Number 840-073
state: Kansas
city: Covington
country: United States
facility: Investigational Site Number 840-062
state: Kentucky
city: Lexington
country: United States
facility: Investigational Site Number 840-042
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site Number 840-009
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 840-032
state: Louisiana
city: Hyattsville
country: United States
facility: Investigational Site Number 840-054
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840-006
state: Maryland
city: Framingham
country: United States
facility: Investigational Site Number 840-157
state: Massachusetts
city: Waltham
country: United States
facility: Investigational Site Number 840-122
state: Massachusetts
city: Flint
country: United States
facility: Investigational Site Number 840-037
state: Michigan
city: Billings
country: United States
facility: Investigational Site Number 840-067
state: Montana
city: Lincoln
country: United States
facility: Investigational Site Number 840-094
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840-033
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840-142
state: Nebraska
city: Henderson
country: United States
facility: Investigational Site Number 840-040
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840-017
state: Nevada
city: New York
country: United States
facility: Investigational Site Number 840-102
state: New York
city: New York
country: United States
facility: Investigational Site Number 840-108
state: New York
city: Staten Island
country: United States
facility: Investigational Site Number 840-109
state: New York
city: Greenville
country: United States
facility: Investigational Site Number 840-045
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 840-010
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 840-080
state: North Carolina
city: Fargo
country: United States
facility: Investigational Site Number 840-051
state: North Dakota
city: Columbus
country: United States
facility: Investigational Site Number 840-123
state: Ohio
city: Mentor
country: United States
facility: Investigational Site Number 840-104
state: Ohio
city: Norman
country: United States
facility: Investigational Site Number 840-079
state: Oklahoma
city: Bend
country: United States
facility: Investigational Site Number 840-162
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840-096
state: Oregon
city: Chattanooga
country: United States
facility: Investigational Site Number 840-058
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site Number 840-003
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840-019
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840-075
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840-005
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840-013
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840-153
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840-026
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840-081
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840-160
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840-156
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840-152
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840-031
state: Texas
city: Lufkin
country: United States
facility: Investigational Site Number 840-140
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840-029
state: Texas
city: North Richland Hills
country: United States
facility: Investigational Site Number 840-048
state: Texas
city: Pearland
country: United States
facility: Investigational Site Number 840-150
state: Texas
city: Murray
country: United States
facility: Investigational Site Number 840-083
state: Utah
city: Ogden
country: United States
facility: Investigational Site Number 840-101
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 840-097
state: Utah
city: Bennington
country: United States
facility: Investigational Site Number 840-143
state: Vermont
city: Burlington
country: United States
facility: Investigational Site Number 840-056
state: Vermont
city: Renton
country: United States
facility: Investigational Site Number 840-015
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840-074
state: Washington
city: Bridgeport
country: United States
facility: Investigational Site Number 840-139
state: West Virginia
city: Manati
country: Puerto Rico
facility: Investigational Site Number 840-111
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: