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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
  Purpose

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


Condition Intervention Phase
DIABETES Mellitus Type 2 Not Well Controlled
Drug: Liraglutide
Drug: Sitagliptin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785043

Contacts
Contact: Anna Cruceta Arbolés, MD 0034 93 227 54 000 ext 4380 acruceta@clinic.ub.es
Contact: Antonio Ceriello, MD aceriell@clinic.ub.es

Locations
Spain
Hospital Clínic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Anna Cruceta Arbolés, MD    0034 93 227 54 00 ext 4380    acruceta@clinic.ub.es   
Contact: Antonio Ceriello, MD       aceriell@clinic.ub.es   
Principal Investigator: Antonio Ceriello, MD         
Sponsors and Collaborators
Anna Cruceta
Investigators
Principal Investigator: Antonio Ceriello, MD Hospital Clinic of Barcelona
  More Information

No publications provided

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
Study First Received: January 7, 2013
Last Updated: February 4, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
DIABETES Mellitus Type 2
Difficult control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014