- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873223
Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir
January 25, 2017 updated by: Novo Nordisk A/S
Insulin Detemir Co-administered With Liraglutide: An Open Label Trial to Assess Insulin Detemir and Liraglutide Pharmacokinetics and Pharmacodynamics Following Liraglutide Therapy in Subjects With Type 2 Diabetes
This trial is conducted in the United States.
The aim of this clinical trial is to investigate whether chronic liraglutide administration affects the mode of action (pharmacokinetics) of insulin detemir
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Chula Vista, California, United States, 91911
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with type 2 diabetes
- BMI less than 45.0 kg/m2
- Insulin naive
- Currently treated with Oral Anti-Diabetic drugs (OADs) and metformin with a HbA1c between 7.0 and 9.5% or currently treated with metformin only with a HbA1c between 7.0 and 10.0%
Exclusion Criteria:
- Any clinically significant disease other than type 2 diabetes
- Currently using daily insulin
- Thiazolidinione use or other injectable diabetes medications within the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration
Subjects will self-inject liraglutide subcutaneously daily during the trial and three euglycemic clamps will be performed: one without liraglutide (insulin detemir alone), the second with only liraglutide treatment and the third with liraglutide and insulin detemir administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin detemir pharmacokinetics with and without liraglutide administration
Time Frame: at approx. 12 weeks (including screening, washout and evaluation period)
|
at approx. 12 weeks (including screening, washout and evaluation period)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of liraglutide with and without insulin detemir
Time Frame: at approx. 12 weeks (including screening, washout and evaluation period)
|
at approx. 12 weeks (including screening, washout and evaluation period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 1, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 25, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-3673
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
Clinical Trials on liraglutide
-
Woman'sNovo Nordisk A/SCompletedPolycystic Ovary Syndrome | Pre Diabetes | Obesity AndroidUnited States
-
Novo Nordisk A/SCompleted
-
The Affiliated Hospital of Qingdao UniversityCompletedTherapeutic EquivalencyChina
-
Sunshine Lake Pharma Co., Ltd.Completed
-
Merck Sharp & Dohme LLCCompleted
-
Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark
-
Parker Research InstituteCompletedOsteoarthritis, KneeDenmark
-
Henrik GudbergsenNovo Nordisk A/S; Cambridge Weight Plan LimitedCompleted
-
Henrik GudbergsenCompletedUltrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance (US-LOSEIT-II)Obesity | OsteoarthritisDenmark
-
Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark