Liraglutide as add-on to Insulin in Type 1 Diabetes

Phase 3CompletedNCT02092896

Hvidovre University Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

LiraglutideDRUG

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.

PlaceboDRUG

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.

LiraglutideDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Endocrinology, Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark

Outcomes

Primary Outcomes

Change from baseline in HbA1c (glycosylated haemoglobin)

Time frame: Week 0, week 12

Changes from baseline in EEG and cognitive performances

Time frame: week 0, week 12

Change from baseline in gastric emptying rate

Time frame: week 0, week 12

Secondary Outcomes

Change from baseline in glycemic control (CGM)

Time frame: week 0, week 12

Change from baseline in total daily insulin dose

Time frame: week 0, week 12

Changes from baseline in the counterregulatory hormone responses during hypoglycemia

Time frame: week 0, week 12

Change from baseline in body weight

Time frame: week 0, week 12

Change from baseline in auditory evoked potentials (AEP) during hypoglycemia

Time frame: week 0, week 12

Change from baseline in corrected QTc-interval (QTc) during hypoglycemia

Time frame: week 0, week 12

Change from baseline in hypoglycemic symptom score

Time frame: week 0, week 12

Data from ClinicalTrials.gov

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