Back to resultsPharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
- Duration of diabetes at least 12 months
- Body Mass Index (BMI) below 33 kg/m^2
- HbA1c maximum 10 % based on analysis from the central laboratory
Exclusion Criteria:
- Current treatment with insulin above 1.2 U/kg/day
- Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
- Blood donation of more than 500 mL within the last three months
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
insulin detemir
insulin NPH
Arm Description
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate curve
Secondary Outcome Measures
Maximum glucose infusion rate
Time to maximum glucose infusion rate.
Area under the serum insulin curve
Maximum serum insulin concentration
Time to maximum insulin concentration
Terminal rate constant of insulin
Terminal half-life of insulin
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01497600
Brief Title
Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Official Title
A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Origin and Whites Not of Hispanic or Latino Origin With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insulin detemir
Arm Type
Experimental
Arm Title
insulin NPH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Secondary Outcome Measure Information:
Title
Maximum glucose infusion rate
Title
Time to maximum glucose infusion rate.
Title
Area under the serum insulin curve
Title
Maximum serum insulin concentration
Title
Time to maximum insulin concentration
Title
Terminal rate constant of insulin
Title
Terminal half-life of insulin
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
Duration of diabetes at least 12 months
Body Mass Index (BMI) below 33 kg/m^2
HbA1c maximum 10 % based on analysis from the central laboratory
Exclusion Criteria:
Current treatment with insulin above 1.2 U/kg/day
Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
Blood donation of more than 500 mL within the last three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16918592
Citation
Hompesch M, Troupin B, Heise T, Elbroend B, Endahl L, Haahr H, Heinemann L. Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Diabetes Obes Metab. 2006 Sep;8(5):568-73. doi: 10.1111/j.1463-1326.2006.00643.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
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