Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Insulin glargine, 300 U/mlDrug: Insulin degludec, 100U/ml
- Registration Number
- NCT04075513
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 343
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Toujeo Insulin glargine, 300 U/ml Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. Tresiba Insulin degludec, 100U/ml Tresiba (Insulin Degludec, 100U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
- Primary Outcome Measures
Name Time Method 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 During Week 10 up to Week 12 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.
- Secondary Outcome Measures
Name Time Method Glucose Total Coefficient of Variation (CV%) During Week 10 up to Week 12 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.
Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis During Week 10 up to Week 12 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.
Glucose Within-day CV% and Between-day CV% During Week 10 up to Week 12 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.
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 Baseline, Week 12 Change in HbA1c at Week 12 was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba), and the continuous fixed covariate of Baseline HbA1c value.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 Baseline, Week 12 Change in FPG was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba) and the randomization stratum of HbA1c at screening (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline FPG value.
Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) During Week 10 up to Week 12 The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. "All time" represent the time between 00.00 hour to 23.59 hours and "night" represent the time between 00.00 hour to 05.59 hours. 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.
Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) During Week 10 up to Week 12 "All time" represent the time between 00.00 hour to 23.59 hours and "night" represent the time between 00.00 hour to 05.59 hours. Mean hours per day with glucose level \<70 milligrams per deciliter during "all time" and only "during night" for the duration of Week 10 to Week 12 is reported in this outcome measure.
Percentage of Time With Glucose Level >180 Milligrams Per Deciliter During Week 10 up to Week 12 The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. 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.
Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter During Week 10 up to Week 12 Mean hours per day with glucose level \>180 milligrams per deciliter for the duration of Week 10 to Week 12 is reported in this outcome measure.
Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 millimoles per liter (mmol/L) (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP.
Number of Hypoglycemic Events Per Participant Year During the On-treatment Period From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) Number of hypoglycemia events (any, severe and documented) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 mmol/L (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Total participant years = The sum of the duration of exposure for all participants, expressed in participant years.
Trial Locations
- Locations (7)
Investigational site United Kingdom
🇬🇧United Kingdom, United Kingdom
Investigational site Hungary
🇭🇺Hungary, Hungary
United States
🇺🇸Dallas, Texas, United States
Investigational site BRAZIL
🇧🇷Brazil, Brazil
Investigational site Netherlands
🇳🇱Netherlands, Netherlands
Investigational site Turkey
🇹🇷Turkey, Turkey
Investigational site Germany
🇩🇪Germany, Germany