Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497561
• Other study ID #: NN304-1538
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2011
• Last updated: January 26, 2017
• Start date: March 2003
• Est. completion date: June 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes

• Subjects treated with insulin for minimum 3 months

• Duration of diabetes for at least 12 months

• Body Mass Index (BMI) below 30 kg/m^2

• HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

• Current treatment with insulin above 1.2 U/kg/day

• Current treatment with insulin glargine

• Current treatment with drugs known to interfere with glucose metabolism

• Current treatment with oral antidiabetic drugs

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
• insulin NPH
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; PREFER Study Group.. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab. 2009 Jan;11(1):45- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve
Secondary	Maximum glucose infusion rate
Secondary	Time to maximum glucose
Secondary	Area under the curve
Secondary	Maximum concentration
Secondary	Time to maximum concentration
Secondary	Insulin clearance
Secondary	Mean residence time of insulin
Secondary	Terminal rate constant
Secondary	Terminal half-life

External Links

•   Clinical Trials at Novo Nordisk