DIABETES Mellitus Type 2 Not Well Controlled Clinical Trial
— LAED001Official title:
Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users: A Randomized, Open-label, Parallel-group and Active Controlled Trial
Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial
| Status | Completed |
| Enrollment | 13 |
| Est. completion date | September 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) 2. Male or female patients between 45 and 65 years old 3. Pre-existing type 2 diabetes with HbA1c between 7.0 and 9.5% 4. Triglycerides >1.68 mmol/L 5. HDL cholesterol <1.29 mmol/L in women and <1.04 mmol/L in men 6. Systolic blood pressure (SBP) <130 mmHg and diastolic blood pressure (DBP) <85 mmHg or treatment with antihypertensive agents Exclusion Criteria: 1. Known or suspected hypersensitivity to trial product(s) or related products 2. Previous participation in this trial. Participation is defined as being randomised. 3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive, or males who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraception 4. Moderate or severe renal dysfunction (creatinine clearance <60 ml/min) 5. Previous type 2 diabetes treatment apart from metformin or insulin 6. Current smoker or history of smoking within 6 months prior to screening. 7. Evidence of overt cardiovascular disease, (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease). 8. Caffeine intake within 24 hours of endothelial function measurements. 9. Use of any drug with known clinically significant sympathetic or parasympathetic effects, as determined by the Investigator. 10. Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering medication within 4 weeks prior to screening and throughout the day. 11. The receipt of any investigational medicinal product within 6 months prior to screening. 12. Presence of cancer or other significant medical condition 13. Inability to follow verbal or written instructions |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clínic de Barcelona | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Anna Cruceta |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin. | The primary objective is to assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin, assessed as the baseline corrected change in endothelial function by flow-mediated vasodilation (FMD) of the brachial artery at 3 months. | 3months | Yes |
| Secondary | The evaluation of other emerging potential cardiovascular risk factors | Secondary objectives will include the evaluation of other emerging potential cardiovascular risk factors, such as oxidative stress markers, cytokines, and soluble cell adhesion molecules. The safety profile of both treatment groups will be also evaluated. |
3months | Yes |