MedTrace Logo

Effects of Liraglutide in Young Adults With Type 2 DIAbetes (LYDIA)

NCT02043054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-30

No results posted yet for this study

Summary

There are recent advances in therapies for the treatment of Type 2 Diabetes Mellitus (T2DM) which include the GLP1 analogues and the DPP IV inhibitors. Both of these therapies target the incretin system using different methods to elevate/maintain circulating levels of GLP1 to subsequently achieve improved blood sugar control. Interestingly, GLP1 analogues have been reported not only to improve blood sugar control but to additionally induce weight-loss and emerging experimental evidence has shown it may have beneficial effects on the heart's structure and function. Due to the profile of this condition being a lot worse and younger patients having greater CVD risk, a therapy offering multiple positive effects, in particular the potential cardiometabolic effects, make this line of therapy attractive in this patient population.

The aim of this research is to investigate the cardiometabolic effects of Liraglutide (GLP1 analogue) compared to that of its clinically relevant comparator Sitagliptin (DPP IV inhibitor).

Conditions

Interventions

DRUG

Liraglutide

Liraglutide (Victoza®, Novo Nordisk) is a stable analogue of the natural hormone glucagon-like peptide-1 (GLP-1). Liraglutide is licensed for use within the United Kingdom and recommended by NICE in combination with metformin, and/or sulphonylurea and/or thiazolidinedione if the following conditions are satisfied. * BMI ≥ 35 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or * BMI \< 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

DRUG

Sitagliptin

Sitagliptin (Januvia®, Merck \& Co) is an enzyme-inhibiting drug used to inhibit the natural enzyme dipeptidyl peptidase-4 (DPP-4). It is an oral antihyperglycaemic agent used in the treatment of T2DM. Sitagliptin is licensed to be used either alone or in combination with other oral antihyperglycemic agents (such as metformin or a sulphonylurea) and is recommended by NICE as a second line therapy.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Melanie Davies, Prof · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-16
Primary Completion
2017-09-02
Completion
2017-09-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02043054 on ClinicalTrials.gov