Diabetes Mellitus
Conditions
Keywords
patients with type 1 diabetes mellitus
Brief summary
The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.
Interventions
DRUGLiraglutide
after optimal treatment on insulin alone 10 patients with type 1 diabetes are treated for four weeks with Liraglutide : in the first week at 0.6 mg sc and after one week optitration to the recommended 1.2 mg sc pr day.
OTHERcontinuous insulin therapy
after optimal treatment with insulin, patients continue on insulin for four weeks
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* age 18-50y, * BMI 18-27, * caucasian origin, * type 1 diabetes diagnosed between age 5 and age 40, * no known diabetes complications or cardiovascular diseases, * no medication known to influence glucose homeostasis, * no pregnancy
Exclusion criteria
* diabetes complications, * autonomous nerve dysfunction, * anaemia, * HbA1c \< 8.5% at screening, * estimated by the investigator to be incapable of completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulin-dose | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 24-hours glucose profiles with and without treatment of Victoza | three days |
| risk of hypoglycemia during physical activity with and without Victoza | one day |
| gastric emptying rate during hypoglycemia with and without Victoza | one day |
| weight change from baseline, change in fructosamine from baseline | four weeks |
Countries
Denmark
Outcome results
None listed