Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users (LAED001)
DIABETES Mellitus Type 2 Not Well Controlled
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users: A Randomized, Open-label, Parallel-group and Active Controlled Trial|
- Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin. [ Time Frame: 3months ] [ Designated as safety issue: Yes ]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.
- The evaluation of other emerging potential cardiovascular risk factors [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
- 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.
|Study Start Date:||March 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day. The starting dose will be 0.6 mg. After one week, the dose will be increased to 1.2 mg, and then it will be increased to 1.8 mg one week later to achieve better control of blood glucose. When Liraglutide is added to existing treatment containing metformin, as it is our scenario, the dose of metformin does not have to be changed.
Liraglutide is available if pre-filled pens (6 mg/ml) as a solution for injection (Victoza®). One ml of solution contains 6 mg of Liraglutide (human glucagon-like peptide-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae). One pre-filled pen contains 18 mg Liraglutide in 3 ml.
Other Name: Victoza®
Active Comparator: Sitagliptin
Sitagliptin will be administered once daily at a 100 mg dose. When Sitagliptin is used in combination with metformin, as it is our scenario, the dose of metformin should be maintained. If a dose of Sitagliptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Sitagliptin will be used daily during the study period of 12 weeks.
Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Other Name: Januvia
Randomized, open-label, parallel-group, active controlled, phase IV study to assess the efficacy and safety of a 3 month treatment period with Liraglutide to Sitagliptin in type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin.The study has been designed with a random design as it is one of the most important techniques for avoiding bias in clinical trials. The study will follow a parallel group, open-label design as liraglutide is administered by subcutaneous injection and sitagliptin orally in tablets. A double-dummy design has been rejected because it is highly complicated in a phase IV study, and any bias of an open-label design has a lower impact on objective variables (as it is our primary endpoint) and it could be compensated with the proposed random design.Sitagliptin has been selected as the active control as it is one of the prescribed treatments for type 2 diabetes patients not well controlled at the maximum tolerated dose of metformin.
The study objectives will be assessed after 3 months of therapy as it is considered a suitable timing for identifying short-term changes on flow-mediated vasodilation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785043
|Hospital Clínic de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Antonio Ceriello, MD||Hospital Clinic of Barcelona|