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A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults with Type 1 Diabetes

A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults with Type 1 Diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016779-31-DE
Enrollment
Unknown
Registered
2010-01-27
Start date
2010-03-19
Completion date
Unknown
Last updated
2012-12-03

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

Conditions

Type 1 Diabetes MedDRA version: 12.1 Level: LLT Classification code 10067584 Term: Type 1 diabetes mellitus

Interventions

Product Name: NN5401 Product Code: NN5401 Pharmaceutical Form: Solution for injection CAS Number: 844439-96-9 Current Sponsor code: NNC 0100-0000-0454 Other descriptive name: insulin 454 Concentration

Sponsors

Novo Nordisk A/S
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Male or female aged 6-65 years (both inclusive) • Type 1 diabetes mellitus (as diagnosed clinically) = 12 months • Body mass index for children and adolescents (male and female) between the 3. and 97. BMI percentile and for adults = 30.0 kg/m2. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Subject who has donated any blood or plasma in the past month, or more than 500 mL within 3 months prior to screening • Not able or willing to refrain from smoking during the inpatient period • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the total exposure of SIAC in children, adolescents and adult subjects with type 1 diabetes;Secondary Objective: • To compare the pharmacokinetic properties of SIAC between the three different age groups • To characterise the pharmacodynamic properties of SIAC in the three different age groups • To assess the safety and tolerability of SIAC in children, adolescents and adult subjects with type 1 diabetes.;Primary end point(s): • AUCI454,0-8,SD, area under the serum insulin 454 concentration-time curve from 0 to infinity after single-dose • AUCIAsp,0-12h,SD, area under the serum insulin aspart concentration-time curve from 0 to 12 hours after single-dose—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026