Phase 4
Completed N=343
Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT04075513 ↗
Enrolled (actual)
343
Serious AEs
4.4%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis — 52.74; 55.09 percentage of time — p=0.0067
◆ Published Evidence
Established
22citations · ~4 / year
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.
Summary
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis |
52.74; 55.09 | 0.0067 sig |
| SECONDARY Glucose Total Coefficient of Variation (CV%) |
39.91; 41.22 | <0.0001 sig |
| SECONDARY Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis |
52.74; 55.09 | 0.0548 |
| SECONDARY Glucose Within-day CV% and Between-day CV% |
33.48; 34.37; 17.23; 18.08 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 |
-0.75; -0.92 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 |
-16.05; -34.55 | — |
| SECONDARY Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) |
5.55; 6.49; 6.32; 6.26 | — |
| SECONDARY Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) |
1.33; 1.56; 0.38; 0.38 | — |
| SECONDARY Percentage of Time With Glucose Level >180 Milligrams Per Deciliter |
41.52; 38.31 | — |
| SECONDARY Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter |
9.96; 9.19 | — |
| SECONDARY Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period |
165; 166; 8; 10; 136; 134 | — |
| SECONDARY Number of Hypoglycemic Events Per Participant Year During the On-treatment Period |
109.4; 114.9; 0.2; 0.3; 67.1; 66.9 | — |
Eligibility 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 ( = 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.
Data sourced from ClinicalTrials.gov (NCT04075513) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.