Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
NCT ID: NCT04075513
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
343 participants
INTERVENTIONAL
2019-10-09
2021-09-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Insulin glargine, 300 U/ml
Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection
Background therapy: Rapid acting insulin analogs
Route of administration: SC injection
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.
Insulin degludec, 100U/ml
Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection
Background therapy: Rapid acting insulin analogs
Route of administration: SC injection
Interventions
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Insulin glargine, 300 U/ml
Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection
Insulin degludec, 100U/ml
Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection
Background therapy: Rapid acting insulin analogs
Route of administration: SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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United States
Dallas, Texas, United States
Investigational site BRAZIL
Brazil, , Brazil
Investigational site Germany
Germany, , Germany
Investigational site Hungary
Hungary, , Hungary
Investigational site Netherlands
Netherlands, , Netherlands
Investigational site Turkey
Turkey, , Turkey (Türkiye)
Investigational site United Kingdom
United Kingdom, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002756-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1197-8171
Identifier Type: OTHER
Identifier Source: secondary_id
LPS14947
Identifier Type: -
Identifier Source: org_study_id
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