To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in HbA1c 16 weeks after randomisation.
Secondary outcome
The confirmatory secondary endpoints are:
* Change from baseline in 1-hour PPG increment 16 weeks after randomisation
(meal test)
* Change from baseline in 1,5 anhydroglucitol 16 weeks after randomisation
* Change from baseline of time spent in low IG (*3.9 mmol/L [70 mg/dL]) during
CGM 16 weeks after randomisation.
Background summary
Data from the Diabetes Control and Complication Trial (DCCT) and UK Prospective
Diabetes Study (UKPDS) shows that improvement in long term glucose control, as
obtained with intensified insulin therapy, can reduce the incidence of
complications and delay the progression of existing complications in Type 1
Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM). Control of
postprandial hyperglycaemia significantly contributes to the glycosylated
haemoglobin (HbA1c) level, and its treatment is essential for achieving the
HbA1c target level. Basal-bolus insulin therapy aims at approaching the
physiological insulin secretion profile in the healthy state to the largest
possible extent. For that purpose, faster-acting insulin analogues have been
developed to more effectively control the postprandial glucose (PPG) excursions
as compared to subcutaneously (s.c.) injected regular human insulin, primarily
through offering a faster onset of action and shorter duration of action.
However, unmet needs exist within faster-acting insulin therapy. The current
insulin analogues are not able to match the speed of the physiological
post-meal insulin secretion, and a faster onset of action is preferred for
tighter PPG control. In addition, a more rapid delivery of the exogenous
insulin to meet postprandial needs is likely to offer increased convenience and
dosing flexibility for the patient.
Study objective
To confirm the effect of continious subcutaneous insulin infusion (CSII
treatment) with faster-acting insulin aspart in terms of glycaemic control by
comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes
Mellitus, using a non-inferiority approach.
Study design
This is a double-blind, randomised, multicentre, multinational, active
controlled, treat-to-target, parallel group trial with a 4-week run-in and a
16-week treatment period comparing the effect and safety of CSII of
faster-acting insulin aspart vs. NovoRapid® in adult Subjects with T1DM.
Subjects entering the trial will stay on their own insulin pump.
The duration of the trial is approximately 26 weeks split into the following
periods:
* 2 weeks for screening period
a 4 week run-in primarily for reinforcement of subject training in trial
procedures, diabetes education and collecting baseline assessments
a 16 week double-blinded treatment period
a 7-day follow up and 30-day safety follow-up period.
50% of the enrolled subjects is allowed to wear their own real-time CGM device
during the entire course of the trial. The remaining enrolled subjects will not
be allowed to wear a CGM device except for three pre-specified periods.
Randomisation will be stratified for the use of own real-time CGM.
Intervention
During the run-in period the subjects will continue their current insulin
treatment. At visit 6 the subjects will be randomised 1:1 to blinded NovoRapid®
or faster-acting insulin aspart. After the 16 weeks of treatment subjects will
switch to commercial available insulin.
Study burden and risks
Subjects are requested to visit the trial site and attend telephone calls more
often than during regular treatment and several assessments are part of
standard diabetes care, but the frequency in the trial is higher.
The personal benefit for the subjects are related to the medical examination
and the benefit from an intensified insulin treatment.
The anticipated risks include hypoglycaemia. hyperglycaemia, infusion site
reactions, CGM related inconvenience, system allergic reactions and antibody
development. Therefor the subject is closely followed during the whole trial.
Part of these risks are also seen in normal diabetescare.
See section 18.2 of the protocol.
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
Male or female, age * 18 years, at the time of signing informed consent
Type 1 diabetes mellitus * 1 year prior to the day of screening
Using the same Medtronic pump (Minimed 530G, Paradigm Veo, Paradigm Revel, Paradigm) with CSII(continuous subcutaneous insulin infusion) in a basal-bolus regimen for at least 6 months prior to screening and willing to stay on the same pump throughout the trial
HbA1c 7.0-9.0%, as assessed by central laboratory at screening
BMI*35.0 kg/m2 at screening
Ability and willigness to take at least 3 daily meal-time insulin bolus infusions every day througout the trial.
Exclusion criteria
Any of the following; myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
History of hospitalisation for ketoacidosis *180 days prior to the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
Any condition which, in the opinion of the Investigator. might jeopardise a Subject's safety or compliance with the protocol.
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 | EUCTR2010-024054-11-NL |
| CCMO | NL54555.018.16 |