Diabetes, Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGliraglutide
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
DRUGinsulin 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
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin detemir pharmacokinetics with and without liraglutide administration | at approx. 12 weeks (including screening, washout and evaluation period) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of liraglutide with and without insulin detemir | at approx. 12 weeks (including screening, washout and evaluation period) |
Countries
United States
Outcome results
None listed