Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
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
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Mar 2003
Shorter than P25 for phase_1 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedJanuary 27, 2017
January 1, 2017
3 months
December 20, 2011
January 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate curve
Secondary Outcomes (9)
Maximum glucose infusion rate
Time to maximum glucose
Area under the curve
Maximum concentration
Time to maximum concentration
- +4 more secondary outcomes
Study Arms (2)
insulin detemir
EXPERIMENTALinsulin NPH
ACTIVE COMPARATORInterventions
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Graz, 8036, Germany
Related 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):45-52. doi: 10.1111/j.1463-1326.2008.00915.x. Epub 2008 Jul 17.
PMID: 18643839RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
March 1, 2003
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
January 27, 2017
Record last verified: 2017-01