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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075513
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE October 9, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
Time in glucose range [ Time Frame: Week 12 ]
Percent (%) time in glucose range of ≥70 to ≤180 mg/dL (≥3.9 to ≤10 mmol/L) at Week 12, obtained using continuous glucose monitoring (CGM)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Glucose total coefficient of variation (CV) [ Time Frame: Week12 ]
    Glucose total CV (%)
  • Glucose within-day CV [ Time Frame: Week12 ]
    Glucose within-day CV (%)
  • Glucose between-day CV [ Time Frame: Week12 ]
    Glucose between-day CV (%)
  • Glycated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 12 ]
    Change from baseline to week 12 in HbA1c
  • Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 12 ]
    Change from baseline to week 12 in FPG
  • Time with Glucose < 70mg/dL [ Time Frame: Week 12 ]
    % time with glucose <70 mg/dL
  • Time with Glucose > 180 mg/dL [ Time Frame: Week 12 ]
    % time with glucose >180 mg/dL
  • Participants with hypoglycemic events [ Time Frame: Baseline to week 12 ]
    Number of participants with at least one hypoglycemic event
  • Hypoglycemic events per participant year [ Time Frame: Baseline to week 12 ]
    Number of hypoglycemic events per participant year
  • Participants with Adverse events [ Time Frame: Baseline to week 12 ]
    Number of participants with Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Official Title  ICMJE 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
Brief Summary

Primary Objective:

To demonstrate the noninferiority of insulin glargine 300 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 (CGM)

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 will be 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Insulin glargine, 300 U/ml

    Pharmaceutical form:solution for injection in a prefilled pen

    Route of administration: subcutaneous injection

    Other Names:
    • Toujeo
    • HOE901-U300
  • Drug: Insulin degludec, 100U/ml

    Pharmaceutical form:solution for injection in a prefilled pen

    Route of administration: subcutaneous injection

    Other Name: Tresiba
  • Drug: Background therapy: Rapid acting insulin analogs
    Route of administration: subcutaneous injection
Study Arms  ICMJE
  • Experimental: Toujeo
    Toujeo (Insulin Glargine, 300U/ml) once daily for 12 weeks on top of rapid acting insulin analog
    Interventions:
    • Drug: Insulin glargine, 300 U/ml
    • Drug: Background therapy: Rapid acting insulin analogs
  • Active Comparator: Tresiba
    Tresiba (Insulin Degludec, 100U/ml) once daily for 12 weeks on top of rapid acting insulin analog
    Interventions:
    • Drug: Insulin degludec, 100U/ml
    • Drug: Background therapy: Rapid acting insulin analogs
Publications * 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. Erratum in: Diabetes Ther. 2020 Jul;11(7):1607-1608. Diabetes Ther. 2020 Aug;11(8):1907-1908.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
338
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Participants with Type 1 Diabetes mellitus (T1DM)
  • Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year
  • HbA1c ≥ 7% (48 mmol/mol) and ≤ 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 using the same insulins (both basal and rapid) within 30 days prior to screening
  • Participants having received basal insulin dose ≥0.6 U/kg 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 kg within 3 months prior to screening

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE Brazil,   Germany,   Hungary,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075513
Other Study ID Numbers  ICMJE LPS14947
2017-002756-91 ( EudraCT Number )
U1111-1197-8171 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP