type 2 diabetes MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Other descriptive name: human glucagon-like peptide-1 (GLP-1)
Sponsors
Fundación Fernández-Cruz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed written consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject). 2. Male or female patients between 18 and 75 years old; 3. Subjects diagnosed with type 2 diabetes for more than 1 year 4. Insulin naïve subjects (Allowed are: Previous short term insulin treatment =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetic patients; 2. Use of a GLP-1 receptor agonist (exenatide, liraglutide or other), pramlintide, thiazolidinediones or any DPP-4 inhibitor within the 3 months prior to screening; 3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (or their partners). Adequate contraceptive measures are considered the use of hormonal based contraceptives in combination with a barrier contraception, 4. Patients with a clinical history of serious cardiovascular events in the last 3 months (myocardial infarction, unstable angina, cerebral infarction, TIA, peripheral arteriopathic event); 5. Suspected or confirmed acute pancreatitis; 6. Personal history of medullary thyroid carcinoma); 7. Patients with congestive heart failure (NYHA I-IV); 8. Moderate or severe renal failure (creatinine clearance 3 times the upper limit of normal, history of cirrhosis or hepatitis; 10. Patients with cancer in the last 10 years; 11. Patients with terminal diseases; 12. Patients unlikely to comply with trial procedures; 13. Known psychiatric disease which may interfere with study procedure; 14. Any other pathology which may interfere with the study results at the investigator?s discretion; 15. Known or suspected contraindications to or history of hypersensitivity to the trial product or related products; 16. Previous participation in this trial i.e. randomised; 17. The receipt of any investigational product within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of treatment with liraglutide compared to glimepiride, as add-on to metformin, for one year on circulating levels of EPCs in patients with type 2 diabetes poorly controlled.;Secondary Objective: To assess the efficacy of liraglutide compared to glimepiride, as add-on to metformin, with regards to other surrogate biomarkers of cardiovascular risk: - IMT - Central blood pressure - CD40 ligand (CD40L) - Highly sensitive c-reactive protein (hsCRP) - lipoprotein-associated phospholipase A2 (Lp-PLA2) - BNP We will also study the relationship between EPC levels and all these biomarkers. Other safety parameters of glycaemic control will also be measured: HbA1c, fasting plasma glucose (FPG) and other laboratory parameters (insulin, lipid profile, creatinine and albumin). They will also be correlated with EPC levels.;Primary end point(s): The primary endpoint will be the change in circulating levels of EPCs after 12 months (Visit 7) of treatment from baseline (Visit 2).;Timepoint(s) of evaluation of this end point: after 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be to compare the following parameters between the treatment arms: IMT, central blood pressure, CD40L, hsCRP, Lp-PLA2, BNP. These secondary endpoints are define similarly to the primary endpoint as the change from baseline (Visit 2) to after 12 months (Visit 7). The following endpoints will also be measured as secondary parameters: ? HbA1c ? FPG ? Biochemistry: insulin, creatinine, albumin and lipid profile (total cholesterol, LDL-c, HDL-c, triglycerides).;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactJuan Luis Sanz
APICES SOLUCIONES S.L.
Outcome results
None listed