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

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ClinicalTrials.gov Identifier: NCT01785043
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : September 15, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial

Condition or disease Intervention/treatment Phase
DIABETES Mellitus Type 2 Not Well Controlled Drug: Liraglutide Drug: Sitagliptin Phase 4

Detailed Description:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2013
Primary Completion Date : March 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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®
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.

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

Outcome Measures

Primary Outcome Measures :
  1. Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin. [ Time Frame: 3months ]
    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.

Secondary Outcome Measures :
  1. The evaluation of other emerging potential cardiovascular risk factors [ Time Frame: 3months ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785043

Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Anna Cruceta
Principal Investigator: Antonio Ceriello, MD Hospital Clinic of Barcelona
More Information

Responsible Party: Anna Cruceta, Project manager Clinical Trials Unit, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01785043     History of Changes
Other Study ID Numbers: LAED001
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Anna Cruceta, Fundació Clínic per la Recerca Biomèdica:
DIABETES Mellitus Type 2
Difficult control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action