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] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | 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 |
to investigate if 12 months’ liraglutide treatment (1.8 mg, strength 6 mg/ml) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin. |
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E.2.2 | Secondary objectives of the trial |
prevention glugoce intolerance and/or increase fasting glugose levels |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
100 women, who have had gestational diabetes with treatment with metformin and/or insulin (fasting P-glucose >5.5 mmol/l at home measurements, in >50% of the measurements per week) and who have stopped lactation and are not pregnant and have signed informed consent are enrolled between 6 to 12 months after delivery. In that consent the women certify that they will use IU-device or oral contraceptive in order to avoid becoming pregnant during the next year. They have BMI>30 kg/m2. |
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E.4 | Principal exclusion criteria |
Diagnosed with diabetes mellitus type 1 or type 2, drugs with potential effect on P-glucose such as use of betablockers, antidepressives, statins and starting any anti-hyperglycemic therapies f.ex insulin, metformin, (as sign of primary end-point reached), new pregnancy. Severe hepatic insufficiency, end stage renal disease, acute pancreatitis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Development of T2DM (fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in OGTT 75g, and/or HbA1c≥ 6.5 %) from year 1 to 5. |
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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) |
2 h PPG measured by 75g OGTT and fasting P-glucose, weight loss, BP, plasma lipids, Metabolic syndrome according to IDF criteria (Central obesity defined as waist circumference ≥ 80cm plus any 2 of the following 4 factors: raised TG level: ≥ 1.7 mmol/L or specific treatment for this; reduced HDL cholesterol: < 1.29 mmol/L or specific treatment for this; raised blood pressure: systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension; raised fasting plasma glucose (FPG) ≥ 5.6 mmol/L or previously diagnosed type 2 diabetes) , development of gestational diabetes |
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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 | Yes |
E.6.3 | Therapy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | No |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |