E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: 18-70 years
BMI: 18-28
HbA1c > 8 %
Patients without residual β-cell function, assessed by a glucagon test with stimulated plasma c-peptide < 60 pM.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The endpoints are evaluated prior to and after 12 weeks of treatment. |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The endpoints are evaluated prior to and after 12 weeks of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |