Treatment of patients with Liraglutide prior to bariatric sugery

Phase 1

• Conditions: Pretreatment of patients with Type 2 diabetes mellitus with expected weight loss surgery (Roux-en-Y Gastric Bypass); MedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-003614-17-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-10
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified