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Trial record 1 of 1 for:    sanofi inRange LPS14947
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Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients (inRange)

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ClinicalTrials.gov Identifier: NCT04075513
Recruitment Status : Completed
First Posted : August 30, 2019
Results First Posted : November 14, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin glargine, 300 U/ml Drug: Insulin degludec, 100U/ml Drug: Background therapy: Rapid acting insulin analogs Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 9, 2019
Actual Primary Completion Date : September 16, 2021
Actual Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Toujeo
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.
Drug: Insulin glargine, 300 U/ml

Pharmaceutical form: solution for injection in a prefilled pen

Route of administration: SC injection

Other Names:
  • Toujeo
  • HOE901-U300

Drug: Background therapy: Rapid acting insulin analogs
Route of administration: SC injection

Active Comparator: Tresiba
Tresiba (Insulin Degludec, 100U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
Drug: Insulin degludec, 100U/ml

Pharmaceutical form: solution for injection in a prefilled pen

Route of administration: SC injection

Other Name: Tresiba

Drug: Background therapy: Rapid acting insulin analogs
Route of administration: SC injection




Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Glucose Total Coefficient of Variation (CV%) [ Time Frame: 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.

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

  3. Glucose Within-day CV% and Between-day CV% [ Time Frame: 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.

  4. Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 [ Time Frame: 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.

  5. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: 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.

  6. Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) [ Time Frame: 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.

  7. Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) [ Time Frame: 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.

  8. Percentage of Time With Glucose Level >180 Milligrams Per Deciliter [ Time Frame: 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.

  9. Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter [ Time Frame: 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.

  10. Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period [ Time Frame: 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.

  11. Number of Hypoglycemic Events Per Participant Year During the On-treatment Period [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075513


Locations
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United States, Texas
United States
Dallas, Texas, United States, 75000
Brazil
Investigational site BRAZIL
Brazil, Brazil
Germany
Investigational site Germany
Germany, Germany
Hungary
Investigational site Hungary
Hungary, Hungary
Netherlands
Investigational site Netherlands
Netherlands, Netherlands
Turkey
Investigational site Turkey
Turkey, Turkey
United Kingdom
Investigational site United Kingdom
United Kingdom, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] May 31, 2019
Statistical Analysis Plan  [PDF] July 1, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04075513    
Other Study ID Numbers: LPS14947
2017-002756-91 ( EudraCT Number )
U1111-1197-8171 ( Other Identifier: UTN )
First Posted: August 30, 2019    Key Record Dates
Results First Posted: November 14, 2022
Last Update Posted: November 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs