E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes |
Type 1 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Type 1 Diabetes |
Type 1 diabetes |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 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 |
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E.2.2 | Secondary objectives of the trial |
Change in insulin pump settings, insulin dose, glucose variability, weight/BMI, body composition, blood pressure, lipid profile, frequency of hypoglycemia defined by ADA, kidney function, number of daily blood glucose measurements, diet, treatment satisfaction and symptoms of depression. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age 18 – 70 years
-T1D ≥ 1 years
-BMI > 25 kg/m2
-HbA1c ≥ 58 mmol/mol (7.5%)
-CSII use ≥ 1 year
-Use of carbohydrate counting and the insulin pump bolus calculator
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E.4 | Principal exclusion criteria |
-Gastroparesis
-Impaired renal function (eGFR < 60 ml/min/1.73m2)
-Liver disease with ALAT > 2.5 times the upper limit of the reference interval
-Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis
-Inflammatory bowel disease
-History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years
-Thyroid adenoma
-Subjects with personal or family history of MTC or MEN2
-Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
-Known or suspected alcohol or drug abuse
-Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
-Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
-Simultaneous participation in any other clinical intervention trial
-Known or suspected hypersensitivity to Liraglutide
-Inability to understand the patient information and to give informed consent
-Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
-Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change in insulin pump settings, insulin dose, glucose variability, weight/BMI, body composition, blood pressure, lipid profile, frequency of hypoglycemia defined by ADA, kidney function, number of daily blood glucose measurements, diet, treatment satisfaction and symptoms of depression. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |