Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users (LAED001)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01785043
First received: January 7, 2013
Last updated: February 4, 2013
Last verified: February 2013

January 7, 2013
February 4, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01785043 on ClinicalTrials.gov Archive Site
The evaluation of other emerging potential cardiovascular risk factors [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
  1. Secondary objectives will include the evaluation of other emerging potential cardiovascular risk factors, such as oxidative stress markers, cytokines, and soluble cell adhesion molecules.
  2. The safety profile of both treatment groups will be also evaluated.
Same as current
Not Provided
Not Provided
 
Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users
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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
DIABETES Mellitus Type 2 Not Well Controlled
  • Drug: Liraglutide
    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®
  • Drug: Sitagliptin
    Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
    Other Name: Januvia
  • Experimental: Liraglutide
    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.
    Intervention: Drug: Liraglutide
  • 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.

    Intervention: Drug: Sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
September 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
45 Years to 65 Years
No
Contact: Anna Cruceta Arbolés, MD 0034 93 227 54 000 ext 4380 acruceta@clinic.ub.es
Contact: Antonio Ceriello, MD aceriell@clinic.ub.es
Spain
 
NCT01785043
LAED001
Yes
Anna Cruceta, Fundació Clínic per la Recerca Biomèdica
Anna Cruceta
Not Provided
Principal Investigator: Antonio Ceriello, MD Hospital Clinic of Barcelona
Fundacion Clinic per a la Recerca Biomédica
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP