Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart administered in the Duodenum in healthy volunteers – an open single blinded and uncontrolled exploratory trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002803-15-DK

Enrollment

Registered

2006-06-19

Start date

2006-08-18

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

Diabetes Mellitus MedDRA version: 9.0 Level: PT Classification code 10012601

Interventions

Trade Name: NovoRapid Novolet Product Name: NovoRapid Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin aspart Concentration unit: IU/ml international unit(s)/millilitre Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Healthy Volunteers •Age >18 - =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any history of gastrointestinal or endocrine disorders (e.g. diabetes)

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the bioavailability of insulin Aspart infused in the Duodenum ;Secondary Objective: •Evaluate pharmacokinetics of insulin following duodenal administration •Evaluate intra- and intersubjects variation in pharmacokinetics •Evaluate pharmacodynamics of insulin •To assess any safety issues •Explore any influence of pH / insulin concentration on PK /PD parameters ;Primary end point(s): •Pharmacokinetics assessed by insulin Aspart and total insulin measurements. •Pharmacodynamics assessed by plasma glucose and further by need to change glucose infusion •Any adverse events	—

Measure

Time frame

Main Objective: To define the bioavailability of insulin Aspart infused in the Duodenum ;Secondary Objective: •Evaluate pharmacokinetics of insulin following duodenal administration •Evaluate intra- and intersubjects variation in pharmacokinetics •Evaluate pharmacodynamics of insulin •To assess any safety issues •Explore any influence of pH / insulin concentration on PK /PD parameters ;Primary end point(s): •Pharmacokinetics assessed by insulin Aspart and total insulin measurements. •Pharmacodynamics assessed by plasma glucose and further by need to change glucose infusion •Any adverse events

—

Countries

Denmark

Outcome results

None listed

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