Diabetes, Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Cognitive performance, Hypoglycemia, Insulin, Glucagon-Like Peptide 1, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, Incretins, Hormones
Brief summary
The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Part 2: To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
Interventions
DRUGLiraglutide
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
DRUGPlacebo
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
Sponsors
NNF Center for Basal Metabolic Research, Denmark
Hillerod Hospital, Denmark
Danish PhD schools of Molecular Metabolism and Endocrinology
Novo Nordisk A/S
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-70 years * BMI: 18-28 * HbA1c ≥ 8 % * No residual β-cell function (glucagon test with c-peptide \< 60 pM) * Caucasian * Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive). * Remission phase must be completed * Female participants must use adequate contraception * Informed consent
Exclusion criteria
* Overt diabetes complications; creatinin \> 130 µM, proliferative retinopathy, macroalbuminuria. * Autonomic neuropathy (RR-variation \</=10 beats/min) and/or Orthostatic hypotension (OH). * Anemia, Hb concentration; female \<7.0 mmol/l, male\<8.0 mmol/l * Pregnancy or lactation * Epilepsy * Use of antiepileptic medication * Use of beta blockers * Previously apoplexy cerebri. * Any use of benzodiazepine within the last month * Any use of neuroleptic drugs within the last six months * Self-perceived hearing loss * Alcohol or drug abuse * Allergy to the medication or placebo. * Treatment with any medication affecting glucose metabolism. * Any disorder which in the investigators opinion could interfere with the safety and results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in gastric emptying rate | week 0, week 12 |
| Change from baseline in HbA1c (glycosylated haemoglobin) | Week 0, week 12 |
| Changes from baseline in EEG and cognitive performances | week 0, week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total daily insulin dose | week 0, week 12 |
| Change from baseline in glycemic control (CGM) | week 0, week 12 |
| Change from baseline in corrected QTc-interval (QTc) during hypoglycemia | week 0, week 12 |
| Change from baseline in hypoglycemic symptom score | week 0, week 12 |
| Change from baseline in auditory evoked potentials (AEP) during hypoglycemia | week 0, week 12 |
| Changes from baseline in the counterregulatory hormone responses during hypoglycemia | week 0, week 12 |
| Change from baseline in body weight | week 0, week 12 |
Other
| Measure | Time frame |
|---|---|
| Frequency of Hypoglycemic episodes | Week 0, week 12 |
Countries
Denmark
Outcome results
None listed