Liraglutide as add-on to Insulin in Type 1 Diabetes

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborators: Danish PhD schools of Molecular Metabolism and Endocrinology; Hillerod Hospital, Denmark; NNF Center for Basal Metabolic Research, Denmark; Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Liraglutide

Criteria

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(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