Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

Sanofi343 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

343

Conditions

Type 1 Diabetes Mellitus

Interventions

Insulin glargine, 300 U/mlDRUG

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

Insulin degludec, 100U/mlDRUG

Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection

Background therapy: Rapid acting insulin analogsDRUG

Route of administration: SC injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (7)

United States

Dallas, Texas, United States

Investigational site BRAZIL

Brazil, Brazil

Investigational site Germany

Germany, Germany

Investigational site Hungary

Hungary, Hungary

Outcomes

Primary Outcomes

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

The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12.

Time frame: During Week 10 up to Week 12

Secondary Outcomes

Glucose Total Coefficient of Variation (CV%)

CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated as ratio of standard deviation of glucose values to mean of glucose values. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value.

Time frame: During Week 10 up to Week 12

Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis

The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations during Week 10 to Week 12.

Time frame: During Week 10 up to Week 12

Glucose Within-day CV% and Between-day CV%

CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated within day and between days as ratio of standard deviation of glucose values to mean of glucose values. LS mean and SE were obtained from ANCOVA model including fixed categorical effects of treatment groups (TOUJEO, TRESIBA), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and as well as, the continuous fixed covariate of Baseline value.

Data from ClinicalTrials.gov

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