"Farmakodynamiske egenskaber af to langtidsvirkende insulinanaloger i sammenligning med NPH insulin"

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003887-31-DK

Enrollment

Registered

2004-11-29

Start date

2004-12-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Healthy subjects.

Interventions

Trade Name: Lantus® Product Name: insulin glargine Product Code: HOE901 Pharmaceutical Form: Solution for injection Trade Name: Levemir® Product Name: insulin detemir Product Code: NN304 Pharmaceutic

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male - > 20 and 20 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Any diagnosis - Disposition to diabetes - Abnormal biochemistry - Any medication - Alcohol or drug abuse - Blood donation within the last 6 months - Participation in a clinical trial within the last 3 months - X-ray examination within the last 12 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the pharmacodynamics of insulin glargine and insulin detemir in comparison to NPH insulin.;Secondary Objective: - Endogene glucose production - Endogene insulin secretion - Counterregulatory hormones, hunger - and satiety hormones - IGF-1 axis - Energy expenditure.;Primary end point(s): - GIR (glucose infusion rate) - Rmax (maximal glucose infusion rate) - TRmax (time for maximal glucose infusion rate).	—

Measure

Time frame

Main Objective: To study the pharmacodynamics of insulin glargine and insulin detemir in comparison to NPH insulin.;Secondary Objective: - Endogene glucose production - Endogene insulin secretion - Counterregulatory hormones, hunger - and satiety hormones - IGF-1 axis - Energy expenditure.;Primary end point(s): - GIR (glucose infusion rate) - Rmax (maximal glucose infusion rate) - TRmax (time for maximal glucose infusion rate).

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Countries

Denmark

Outcome results

None listed

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