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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873223
• Other study ID #: NN2211-3673
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: January 25, 2017
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

Morrow L, Hompesch M, Guthrie H, Chang D, Chatterjee DJ. Co-administration of liraglutide with insulin detemir demonstrates additive pharmacodynamic effects with no pharmacokinetic interaction. Diabetes Obes Metab. 2011 Jan;13(1):75-80. doi: 10.1111/j.146 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin detemir pharmacokinetics with and without liraglutide administration		at approx. 12 weeks (including screening, washout and evaluation period)
Secondary	Pharmacokinetics of liraglutide with and without insulin detemir		at approx. 12 weeks (including screening, washout and evaluation period)

External Links

•   Clinical Trials at Novo Nordisk