Skip to main content
OpenTrials
Completed

NCT Number: NCT00873223

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

insulin detemir

Drug

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

Primary outcomes

  1. Insulin detemir pharmacokinetics with and without liraglutide administration

    Time frame: at approx. 12 weeks (including screening, washout and evaluation period)

Secondary outcomes

  1. Pharmacokinetics of liraglutide with and without insulin detemir

    Time frame: at approx. 12 weeks (including screening, washout and evaluation period)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 1, 2009
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.