BEGIN: YOUNG 1, trial id: NN1250-3561. A clinical trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

BEGIN: YOUNG 1, trial id: NN1250-3561. A clinical trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus. - NN1250-3561

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37499

Enrollment

Registered

2011-10-21

Start date

2012-02-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus type 1 insulin dependent diabetes

Interventions

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

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: -known or suspected hypersensitivity to trial product -known hypoglycaemic unawareness -more than 1 ketoacidosis requiring hospitalisation within the last 3 months

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1c after 26 weeks of treatment.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)