Title
Liraglutide as add-on to Insulin in Type 1 Diabetes
Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
Phase
Phase 3Lead Sponsor
University of CopenhagenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetes Mellitus, Type 1 DiabetesIntervention/Treatment
liraglutide ...Study Participants
40The 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.
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.
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.
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 2 is performed.
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 2 is performed.
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
