E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pretreatment of patients with Type 2 diabetes mellitus with expected weight loss surgery (Roux-en-Y Gastric Bypass) |
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E.1.1.1 | Medical condition in easily understood language |
Pretreatment of patients with diabetes mellitus with expected weight loss surgery |
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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 | 14.1 |
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 compare body weight of patients with type 2 DM scheduled for weight loss surgery (RYGB) after 8 weeks of preoperative treatment with liraglutide to patients with type 2 DM treated with placebo |
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E.2.2 | Secondary objectives of the trial |
To asses liver size (right and left liver lobe), operative time, GLP-1 levels prior and post operation and the incidence and quantification of postoperative nausea and vomiting. Also the length of hospital stay and intraoperative complication rate will be analyzed. Furthermore to assess change of body weight after a 8 week preoperative treatment at 1, 2 and 3 days after surgery |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed and dated informed consent obtained before any trial-related activities or procedures 2. Male or female 3. Aged 18 - 70 years 4. BMI of 35 – 50 kg/m² 5. Fasting blood glucose > 140 mg / dL 6. Diabetes mellitus type 2 7. Oral antidiabetic treatment 8. Scheduled for bariatric surgery
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E.4 | Principal exclusion criteria |
1. Contraindication for liraglutide treatment as defined in the Summary of Product Characteristics (SmPC) 2. Suspected or known hypersensitivity to liraglutide or any of its components 3. Women of childbearing potential who are either breastfeeding, pregnant or not using a medically acceptable method of birth control 4. Treatment with DPP IV inhibitors or GLP-1 analogues within the last three months 5. Treatment with Insulin 6. Pre-treatment with Liraglutide 7. Type 1 diabetes mellitus 8. Serious thyroid dysfunction (ft4 > 2 times normal value) 9. Heart insufficiency (NYHA 3 – 4) 10. Renal failure (GFR < 50 L/min) 11. Suspected or known drug or alcohol abuse 12. Participation in another clinical trial 13. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
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E.5 End points |
E.5.1 | Primary end point(s) |
- Weight prior to surgery |
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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 of body weight after a 8 week preoperative treatment phase at V2 and at 1, 2 and 3 days after surgery compared to preoperative weight at V1 - Change in Liver size (right-, and left liver lobe) as assessed by ultrasound at V1 and after 8 weeks of Liraglutide application prior to surgery at V2 - Operative time defined as time between section and suture - Quantification of intraoperative complications - Pre and post operative GLP – 1 levels - Quantification of postoperative vomiting - Extend of postoperative nausea as assessed by patient’s perception - Postoperative nausea and vomiting as assessed by questionnaires 1, 2, 3 days post surgery and at discharge - Duration of hospitalization
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |