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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 : Recruiting
First Posted : August 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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


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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Toujeo
Toujeo (Insulin Glargine, 300U/ml) once daily 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: subcutaneous injection

Other Names:
  • Toujeo
  • HOE901-U300

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

Active Comparator: Tresiba
Tresiba (Insulin Degludec, 100U/ml) once daily 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: subcutaneous injection

Other Name: Tresiba

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Glucose total coefficient of variation (CV) [ Time Frame: Week12 ]
    Glucose total CV (%)

  2. Glucose within-day CV [ Time Frame: Week12 ]
    Glucose within-day CV (%)

  3. Glucose between-day CV [ Time Frame: Week12 ]
    Glucose between-day CV (%)

  4. Glycated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 12 ]
    Change from baseline to week 12 in HbA1c

  5. Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 12 ]
    Change from baseline to week 12 in FPG

  6. Time with Glucose < 70mg/dL [ Time Frame: Week 12 ]
    % time with glucose <70 mg/dL

  7. Time with Glucose > 180 mg/dL [ Time Frame: Week 12 ]
    % time with glucose >180 mg/dL

  8. Participants with hypoglycemic events [ Time Frame: Baseline to week 12 ]
    Number of participants with at least one hypoglycemic event

  9. Hypoglycemic events per participant year [ Time Frame: Baseline to week 12 ]
    Number of hypoglycemic events per participant year

  10. Participants with Adverse events [ Time Frame: Baseline to week 12 ]
    Number of participants with Adverse events



Information from the National Library of Medicine

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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 (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.


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


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, New York
United States Recruiting
New York, New York, United States, 00000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04075513     History of Changes
Other Study ID Numbers: LPS14947
2017-002756-91 ( EudraCT Number )
U1111-1197-8171 ( Other Identifier: UTN )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
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://www.clinicalstudydatarequest.com/

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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, Long-Acting
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs