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

NCT00873223 | Completed Phase 1

• 1 other identifier: NN2211-3673
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Insulin detemir pharmacokinetics with and without liraglutide administration

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

Secondary Outcomes (1)

• Pharmacokinetics of liraglutide with and without insulin detemir

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

Study Arms (1)

A

EXPERIMENTAL

Drug: liraglutide; Drug: insulin detemir

Interventions

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

A

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Location

Related 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.1463-1326.2010.01322.x.

  PMID: 21114606 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide; Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

US (1)