To demonstrate the noninferiority of insulin glargine 300 U/mLin comparison to insulin degludec 100 U/mL on glycemiccontrol and variability in participants with diabetes mellitus
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
At Week 12, the following endpoints will be assessed:
* Glucose total CV
* Glucose within-day and between-day CV
Other secondary endpoints:
* Change from baseline to Week 12 in HbA1c
* Change from baseline to Week 12 in central lab FPG
* Percent time and mean hours per day with
glucose<70mg/dL (on all time and during the night
[00:00 to 05:59])
* Percent time and mean hours per day with
glucose>180mg/dL
Number of participants with adverse events (see Section 8.3)
Number of participants with at least one hypoglycemic event
from baseline to Week 12
Number of hypoglycemic events per participant year from
baseline to Week 12
Background summary
The fluctuations in blood glucose, regular short-duration periods of
hyperglycemia and
hypoglycemia, which are not detected by the measurements of glycated hemoglobin
(HbA1c),
may possibly contribute to vascular pathological processes and diabetic
complications.
Insulin glargine U300 (HOE901-U300, Toujeo®) is a more concentrated formulation
of insulin
glargine U100 (HOE901) which showed a prolonged and flatter glucose-lowering
activity (up to
36 hours) compared to Lantus (Insulin glargine U100), resulting in less
circadian fluctuation in
blood glucose levels (1). Given these features of the pharmacokinetic
(PK)/pharmacodynamics
(PD) profiles, Toujeo is considered to be well suitable for constant, peakless
24-hour basal insulin
supply in diabetes management, with the expectation of less hypoglycemic risk
at equal to tighter
blood glucose control.
Study 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
Study design
This is a multicenter, randomized, active-controlled, parallel-group, 12-week
open-label study to
compare the efficacy of Toujeo with Tresiba using 20-day CGM glucose profiles
at Week 12. The
CGM during study period will be blinded to both the Investigators and patients
Intervention
Patients taking their current basal insulin at any time (eg, evening) other
than in the morning should switch their injection time to the morning
at randomization.
Study burden and risks
because participants are frequently monitored for blood glucose values, the
risk of hyperglycemia and hypogykemie are low.
Participants should be regularly monitored for 12 weeks and need 2x 20 days to
wear a continuous glucose meter with them. minimum blood samples can be
considered standard of care for this group of participants
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-002756-91-NL |
| CCMO | NL71287.056.19 |