Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users

NCT01785043 | Completed Phase 4 DMC

• 1 other identifier: LAED001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

DIABETES Mellitus Type 2 Not Well Controlled

Keywords

DIABETES Mellitus Type 2; Difficult control

Outcome Measures

Primary Outcomes (1)

• Assess the effects on endothelial function of a three month treatment with Liraglutide compared to Sitagliptin.

  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.

  3months

Secondary Outcomes (1)

• The evaluation of other emerging potential cardiovascular risk factors

  3months

Study Arms (2)

Liraglutide

EXPERIMENTAL

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

Sitagliptin

ACTIVE COMPARATOR

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

Interventions

Liraglutide 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.

Also known as: Victoza®

Liraglutide

Sitagliptin DRUG

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

Also known as: Januvia

Sitagliptin

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• Male or female patients between 45 and 65 years old
• Pre-existing type 2 diabetes with HbA1c between 7.0 and 9.5%
• Triglycerides \>1.68 mmol/L
• HDL cholesterol \<1.29 mmol/L in women and \<1.04 mmol/L in men
• Systolic blood pressure (SBP) \<130 mmHg and diastolic blood pressure (DBP) \<85 mmHg or treatment with antihypertensive agents

You may not qualify if:

• Known or suspected hypersensitivity to trial product(s) or related products
• Previous participation in this trial. Participation is defined as being randomised.
• 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
• Moderate or severe renal dysfunction (creatinine clearance \<60 ml/min)
• Previous type 2 diabetes treatment apart from metformin or insulin
• Current smoker or history of smoking within 6 months prior to screening.
• Evidence of overt cardiovascular disease, (documented coronary heart disease, class II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular disease).
• Caffeine intake within 24 hours of endothelial function measurements.
• Use of any drug with known clinically significant sympathetic or parasympathetic effects, as determined by the Investigator.
• Initiation or change (dose or treatment regimen) in concomitant blood pressure-lowering medication within 4 weeks prior to screening and throughout the day.
• The receipt of any investigational medicinal product within 6 months prior to screening.
• Presence of cancer or other significant medical condition
• Inability to follow verbal or written instructions

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Antonio Ceriello, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager Clinical Trials Unit

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: February 6, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

ES (1)