Type 1 Diabetes MedDRA version: 14.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg milligram(s)
Con
Sponsors
Sten Madsbad
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: To investigate how long-term treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate. Part 2: 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: 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. Part 2: 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1: -To evaluate the dose of insulin required, assessed by mean insulin requirement (U/day) -To evaluate the effects on gastric emptying rate prior to and after treatment with liraglutide, simultaneously measuring the counterregulatory hormone responses. -Comparison of 5 days glucose profiles, including evaluation of glycemic variability. -changes in body weight Part 2: -Evaluation of counterregulatory hormone responses -Evaluation of auditory evoked potentials (AEP) -Evaluation of the QT-interval, assessed by ECG -Evaluation of hypoglycemic symptom score. ;Timepoint(s) of evaluation of this end point: The endpoints are evaluated prior to and after 12 weeks of treatment. | — |
Countries
Denmark
Contacts
Public ContactDept. of Endocrinology, 215
Christian Frandsen
Outcome results
None listed