Clinical trial NCT04075513: Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Official title: A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring 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: 2019-08-30
Enrollment: 343
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 the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus.

Secondary Objective:

To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring.

To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.

Detailed description: The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period.

Eligibility criteria: Inclusion criteria :

* Participants with Type 1 Diabetes mellitus.
* Participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year.
* HbA1c greater than or equal to (\>=) 7 percent (%) (53 millimoles per mole \[mmol/mol\]) and less than or equal to (\<=) 10% (86 mmol/mol) at screening.

Exclusion criteria:

* Participants not on stable dose of basal insulin analog.
* Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening.
* Participants not having used the same insulins (both basal and rapid) within 30 days prior to screening.
* Participants having received basal insulin dose \>= 0.6 units per kilogram body weight within 30 days prior to screening.
* Participants having received any glucose lowering drugs (including any premixed insulins, human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening.
* End stage renal disease or on renal replacement treatment.
* Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery.
* Body weight change \>=5 kilogram within 3 months prior to screening.

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

Primary outcomes:
measure: Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis
timeFrame: During Week 10 up to Week 12
Secondary outcomes:
measure: Glucose Total Coefficient of Variation (CV%)
timeFrame: During Week 10 up to Week 12
measure: Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis
timeFrame: During Week 10 up to Week 12
measure: Glucose Within-day CV% and Between-day CV%
timeFrame: During Week 10 up to Week 12
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
timeFrame: During Week 10 up to Week 12
measure: Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
timeFrame: During Week 10 up to Week 12
measure: Percentage of Time With Glucose Level >180 Milligrams Per Deciliter
timeFrame: During Week 10 up to Week 12
measure: Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter
timeFrame: During Week 10 up to Week 12
measure: Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period
timeFrame: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
measure: Number of Hypoglycemic Events Per Participant Year During the On-treatment Period
timeFrame: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: United States
state: Texas
city: Brazil
country: Brazil
facility: Investigational site BRAZIL
city: Germany
country: Germany
facility: Investigational site Germany
city: Hungary
country: Hungary
facility: Investigational site Hungary
city: Netherlands
country: Netherlands
facility: Investigational site Netherlands
city: Turkey
country: Turkey
facility: Investigational site Turkey
city: United Kingdom
country: United Kingdom
facility: Investigational site United Kingdom
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Battelino T, Bosnyak Z, Danne T, Mukherjee B, Edelman S, Pilorget V, Choudhary P, Renard E, Bergenstal R. InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther. 2020 Apr;11(4):1017-1027. doi: 10.1007/s13300-020-00781-6. Epub 2020 Feb 25.