Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients (inRange)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Background therapy: Rapid acting insulin analogs; Drug: Insulin glargine, 300 U/ml; Drug: Insulin degludec, 100U/ml

Study type: Interventional

Funder types: Industry

Identifiers

NCT04075513

2017-002756-91 (EudraCT Number)

U1111-1197-8171 (Other Identifier)

LPS14947

Details and patient eligibility

About

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.

Full 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.

Enrollment: 343 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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343 participants in 2 patient groups

Toujeo

Experimental group

Description:

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.

Treatment:

Drug: Background therapy: Rapid acting insulin analogs

Drug: Insulin glargine, 300 U/ml

Tresiba

Active Comparator group

Description:

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

Treatment:

Drug: Insulin degludec, 100U/ml

Drug: Background therapy: Rapid acting insulin analogs