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

Sponsor
University of Leicester
Study ID
NCT02043054
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    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.
  • Sitagliptin — DRUG
    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.

Study Details

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).

Key Dates

Start date
Dec 16, 2013
Status verified
Nov 2016
Primary completion
Sep 2, 2017
Completion
Sep 29, 2017

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Liraglutide doses will be self-administered by the participant through daily subcutaneous injections. Liraglutide doses will be initiated at 0.6 mg and then increased to 1.2 mg in week two and 1.8mg in week three. The dose will then be maintained at 1.8 mg. Where 1.8 mg doses are not tolerated by the patient, the dose will be lowered to the maximum tolerated dose at the investigators discretion.
  • Active Comparator: Sitagliptin
    Sitagliptin doses will be self-administered by the participant orally at 100mg/day throughout the 26 week period of the study. Sitagliptin is licensed to be used either alone or in combination with other oral antihyperglycemic agents (such as metformin or a sulphonylurea)

Primary Outcome Measure

Change in peak early diastolic strain rate measured by cardiac MRI [ Time Frame: Change from baseline peak end diastolic strain rate at 26 weeks ]

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