Primary objectiveTo confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in HbA1c from baseline week 0 (V2) to week 26
Secondary outcome
Secondary efficacy endpoints
-Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26
-Time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week 22 to week 26
-Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total
treatment satisfaction from baseline (week 0) to week 26
-Change in HbA1c from baseline (week 0) to week 52
Secondary safety endpoints
-Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to
week 26
-Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L
(54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 26
-Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L
(54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
from baseline (week 0) to week 26
-Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to
week 57
-Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L
(54 mg/dL), confirmed by BG meter) from baseline (week 0) to week 57
-Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L
(54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
from baseline (week 0) to week 57
-Number of nocturnal clinically significant hypoglycaemic episodes (level 2)
(<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic
episodes (level 3) from baseline (week 0) to week 26
-Number of nocturnal clinically significant hypoglycaemic episodes (level 2)
(<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic
episodes (level 3) from baseline (week 0) to week 57
-Time spent < 3.0 mmol/L (54 mg/dL) from week 22 to week 26
-Time spent > 10 mmol/L (180 mg/dL) from week 22 to week 26
-Mean total weekly insulin dose from week 24 to week 26
-Mean total weekly insulin dose from week 50 to week 52
-Change in body weight from baseline (week 0) to week 26
Background summary
T1D is a heterogeneous disorder characterised by T cell-mediated autoimmune
destruction of insulin-producing beta cells in the pancreas. The destruction of
beta cell function leads to insulin deficiency and the requirement of lifelong
administration of exogenous insulin. Results from the
DCCT study and the follow-up study (EDIC) have demonstrated the importance of
maintaining tight glycaemic control to reduce the risk of long-term
complications associated with diabetes. As such, the fundamental principle for
insulin treatment of T1D is to mimic normal physiological
patterns as closely as possible. The current gold standard of care is based on
intensive insulin therapy with multiple daily injections of prandial and basal
insulin or continuous subcutaneous insulin infusion.
Study objective
Primary objective
To confirm the effect on glycaemic control of once weekly insulin icodec in
combination with insulin aspart, in subjects with T1D. This includes comparing
the difference in change from baseline in HbA1c between once weekly insulin
icodec and once daily insulin degludec both in combination with insulin aspart
after 26 weeks of treatment to a non-inferiority limit of 0.3%.
Secondary objective
To compare the safety and patient reported outcomes of once weekly insulin
icodec versus once daily insulin degludec, both in combination with insulin
aspart, in subjects with T1D.
Study design
This is a 26-week randomised, multicentre, multinational, open-label, active
controlled, parallel group, two-armed, treat-to-target trial with two treatment
arms. Subjects will be randomised (1:1) to receive either insulin icodec or
once daily insulin degludec, both in combination with 2-4 daily bolus
injections of insulin aspart. Randomisation of subjects will be stratified
based on pre-trial basal insulin regimen and by HbA1c (either <8% or >= 8%) at
screening.
Intervention
Subjects will be randomised (1:1) to a treat-to-target basal-bolus insulin
regimen with either once weekly insulin icodec or once daily insulin degludec,
both in combination with insulin aspart.
Study burden and risks
Insulin icodec is efficacious at clinically relevant doses. Titration guidance
for phase 3a trials aims to achieve good glycaemic control without increasing
the risk of hypoglycaemic events.
No new significant safety information that changes the current benefit-risk
profile of insulin icodec emerged from the ongoing and completed clinical
trials. The safety profile of insulin icodec remains in line with the
cumulative experience.
As an overall assessment, Novo Nordisk evaluates that the benefit-risk balance
of insulin icodec remains favourable.
Considering the measures taken to minimise risk to subjects participating in
this trial, the risks identified in association with insulin icodec are
justified by the anticipated benefits that may be afforded to subjects with
diabetes mellitus.
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Listed location countries
Age
Inclusion criteria
-Male or female aged 18 years or more at the time of signing informed consent.
-Diagnosed with type 1 diabetes mellitus at least 1 year prior to the day of
screening.
-Treated with multiple daily insulin injections (basal and bolus insulin
analogue regimes) at least 1 year prior to the day of screening.
-HbA1c below 10% at screening visit based on analysis from central laboratory.
Exclusion criteria
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris
or transient ischaemic attack within 180 days prior to the day of screening.
-Chronic heart failure classified as New York Heart Association (NYHA) Class IV
at screening.
-Anticipated initiation or change in concomitant medications (for more than 14
consecutive days) known to affect weight or glucose metabolism (e.g. treatment
with orlistat, thyroid hormones, or corticosteroids).
-Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
Verified by a fundus examination performed within the past 90 days prior to
screening or in the period between screening and randomisation. Pharmacological
pupil-dilation is a requirement unless using a digital fundus photography
camera specified for non-dilated examination.
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 | EUCTR2020-002374-27-NL |
| CCMO | NL76301.041.21 |
| Other | UTN: U1111-1251-7315 |