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Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart following Subcutaneous Insulin Infusion (CSII) - Basal Rate Resolution.

Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart following Subcutaneous Insulin Infusion (CSII) - Basal Rate Resolution.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001912-21-DK
Enrollment
Unknown
Registered
2007-05-24
Start date
2007-06-26
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 1 diabetes mellitus Continious subcutaneous insulin infusion (CSII) MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: NovoRapid Product Name: NovoRapid Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094236 Concentration unit: IU/ml international unit(s)/mil

Sponsors

Aarhus Sygehus, Universityhospital of Aarhus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Type 1 diabetes mellitus (T1DM) - Insulin pump users’ = 48 hours, 24 h dose =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Dysregulation of endocrine disorders other than type 1 diabetes mellitus - Severe dysregulation of diabetes mellitus - Other severe adverse disease - Pregnancy, planning pregnancy, or nursing

Design outcomes

Primary

MeasureTime frame
Main Objective: To define the bioavaliability, pharmacokinetics, and pharmacodynamics of insulin aspart following subcutaneous insulin infusion (CSII)- definition of basal rate resolution.;Secondary Objective: ;Primary end point(s): Primary endpoint: - Coefficient of variation of steadystate plasma insulin aspart Secondary endpoints: - Bioavaliability of plasma insulin aspart under steadystate (AUC) - Bioequivalence of insulin aspart under steadystate (GIR, S-FFA, S-glycerol)—

Countries

Denmark

Outcome results

None listed

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