Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…
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 after 26 weeks of treatment.
Secondary outcome
Efficacy: change from baseline in fasting plasma glucose after 26 weeks of
treatment, several parameters from 8-point profile and 4-point profile
Safety: amongst others; number of hypo- and hyperglycaemic episodes in both
treatment arms, insulin antibody measurement and laboratory parameters
(hematology, biochemistry and lipids).
Pharmacokinetics: insulin degludec and insulin detemir plasmaconcentration.
Background summary
This trial is being conducted in agreement with the EMA Paediatric Committee
(PDCO) to investigate the efficacy and safety of insulin degludec in children
and adolescents with type 1 diabetes. Although several insulin products are
available on the market and can be used by paediatric patients, there is still
a need for refinement of these products to more closely resemble the
physiological action profile of endogenous insulin and to reduce unwanted side
effects. Based on available clinical data insulin degludec has shown to have a
flat profile and a prolonged action profile compared to the insulin products
currently on the market.
Study objective
Primary objective: to confirm the efficacy of insulin degludec administered
once daily plus mealtime insulin aspart in controlling glycaemia with respect
to change from baseline in HbA1c after 26 weeks of treatment.
Secundary objective: to compare the efficacy and safety between the two
treatment arms after 26 weeks of treatment in terms of other parameters of
glycaemic control, safety and pharmacokinetics.
Study design
This is an open-labelled, randomised trial with 2 parallel groups: 1) insulin
degludec and 2) insulin detemir, both in combination with insulin aspart.
Subjects will be randomised 1:1 in one of the two groups. The treatment period
is 26 weeks followed by a wash-out week.
Intervention
The intervention is a daily injection with insulin degludec or once to twice
daily injection with insulin detemir. In both groups subject should also inject
themselves before each meal with insulin aspart. During the wash-out period
subjects take one to twice daily injections with insulin NPH and injections of
insulin aspart before each meal.
Study burden and risks
It is possible that blooddrawals can cause haemorrhages or discomfort.
Intensification of insulin treatment can lead to hypoglycaemic episodes.
Subjects on insulin degludec, can experience that their hypo's lasts longer due
to the prolonged action of insulin degludec.
Flemingweg 18
2408 AV Alphen a/d Rijn
NL
Flemingweg 18
2408 AV Alphen a/d Rijn
NL
Listed location countries
Age
Inclusion criteria
-type 1 diabetes mellitus
-age: 1 to less than 18 years of age
-ongoing daily treatment with insulin for at least three months
-HbA1c of 11% or below
Exclusion criteria
-known or suspected hypersensitivity to trial product
-known hypoglycaemic unawareness
-more than 1 ketoacidosis requiring hospitalisation within the last 3 months
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
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003148-39-NL |
| CCMO | NL38149.060.11 |