Treatment of type 1 diabetes with the drug liraglutide. The effects on blood sugar control, and metabolic hormones and function of the brain at low blood sugar levels.

Conditions: Type 1 Diabetes
MedDRA version: 14.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-002526-67-DK

Lead Sponsor: Sten Madsbad

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age: 18-70 years
BMI: 18-28
HbA1c > 8 %
Patients without residual ß-cell function, assessed by a glucagon test with stimulated plasma c-peptide < 60 pM.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Overt diabetes complications; creatinin > 130 µM, proliferativ retinopathy, makroalbinuri, significant heart disease requiring treatment.
Autonomic nerve dysfunction
Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
Pregnancy or lactation (pregnancy test will be done at screening)
Epilepsy
Previously apopleksia cerebri or any kind of brain pathology.
Alcohol or drug abuse

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part 1:<br>To investigate how long-term treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate.<br>Part 2:<br>To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide or placebo, respectively, affects counterregulatory hormones and cognitive performance during hypoglycemia.;Secondary Objective: Please refer to E.2.1;Primary end point(s): Part 1:<br>To evaluate glycemic control prior to and after 12 weeks of treatment with liraglutide, assessed by HbA1c and time spent in hypoglycemia, normoglycemia and hyperglycemia.<br>Part 2:<br>Evaluation of changes in EEG and cognitive performances.;Timepoint(s) of evaluation of this end point: The endpoints are evaluated prior to and after 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Part 1:<br>-To evaluate the dose of insulin required, assessed by mean insulin requirement (U/day)<br>-To evaluate the effects on gastric emptying rate prior to and after treatment with liraglutide, simultaneously measuring the counterregulatory hormone responses.<br>-Comparison of 5 days glucose profiles, including evaluation of glycemic variability.<br>-changes in body weight<br>Part 2:<br>-Evaluation of counterregulatory hormone responses<br>-Evaluation of auditory evoked potentials (AEP)<br>-Evaluation of the QT-interval, assessed by ECG<br>-Evaluation of hypoglycemic symptom score.<br>;Timepoint(s) of evaluation of this end point: The endpoints are evaluated prior to and after 12 weeks of treatment.