Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users

NCT ID: NCT01785043

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-09-30

Brief Summary

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

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

Conditions

DIABETES Mellitus Type 2 Not Well Controlled

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Liraglutide

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.

Interventions

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.

Intervention Type: DRUG

Sitagliptin

Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.

Intervention Type: DRUG

Other Intervention Names

Victoza®; Januvia

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anna Cruceta

OTHER

Sponsor Role: lead

Responsible Party

Anna Cruceta

Project manager Clinical Trials Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonio Ceriello, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

LAED001

Identifier Type: -

Identifier Source: org_study_id