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Examination of the Effects of Liraglutide on the Mode of Action of Insulin Detemir

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873223
First Posted: April 1, 2009
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: insulin detemir Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin detemir pharmacokinetics with and without liraglutide administration [ Time Frame: at approx. 12 weeks (including screening, washout and evaluation period) ]

Secondary Outcome Measures:
  • Pharmacokinetics of liraglutide with and without insulin detemir [ Time Frame: at approx. 12 weeks (including screening, washout and evaluation period) ]

Enrollment: 33
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: liraglutide
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
Drug: insulin detemir
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873223


Locations
United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00873223     History of Changes
Other Study ID Numbers: NN2211-3673
First Submitted: March 31, 2009
First Posted: April 1, 2009
Last Update Posted: January 26, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Liraglutide
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists