inRange: Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Study Details
Study Description
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 |
|---|---|---|
|
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
Study Design
Arms and Interventions
| 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:
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 Names:
Drug: Background therapy: Rapid acting insulin analogs
Route of administration: subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Time in glucose range [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
- Glucose total coefficient of variation (CV) [Week12]
Glucose total CV (%)
- Glucose within-day CV [Week12]
Glucose within-day CV (%)
- Glucose between-day CV [Week12]
Glucose between-day CV (%)
- Glycated hemoglobin (HbA1c) [Baseline to Week 12]
Change from baseline to week 12 in HbA1c
- Fasting Plasma Glucose (FPG) [Baseline to Week 12]
Change from baseline to week 12 in FPG
- Time with Glucose < 70mg/dL [Week 12]
% time with glucose <70 mg/dL
- Time with Glucose > 180 mg/dL [Week 12]
% time with glucose >180 mg/dL
- Participants with hypoglycemic events [Baseline to week 12]
Number of participants with at least one hypoglycemic event
- Hypoglycemic events per participant year [Baseline to week 12]
Number of hypoglycemic events per participant year
- Participants with Adverse events [Baseline to week 12]
Number of participants with Adverse events
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | United States | Dallas | Texas | United States | 75000 |
| 2 | Investigational site BRAZIL | Brazil | Brazil | ||
| 3 | Investigational site Germany | Germany | Germany | ||
| 4 | Investigational site Hungary | Hungary | Hungary | ||
| 5 | Investigational site Netherlands | Netherlands | Netherlands | ||
| 6 | Investigational site Turkey | Turkey | Turkey | ||
| 7 | Investigational site United Kingdom | United Kingdom | United Kingdom |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LPS14947
- 2017-002756-91
- U1111-1197-8171