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

• Status: Completed
• Trial end date: 2017-09-29
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborators: Novo Nordisk A/S; University Hospitals, Leicester
• Treatments: Hypoglycemic Agents; Liraglutide; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Capacity to provide informed consent before any trial-related activities

• Individuals aged 18 - 60 years inclusive

• Established T2DM

• BMI ≥ 30 kg/m2 (≥27 kg/m2 for South Asians or other BME populations)

• On mono or combination oral OAD therapy (sulphonylurea and/or metformin) for ≥ 3months

• No prescribed thiazolidinediones within the last 3 months

• An HbA1c value of greater than or equal to 6.5% and less than 10%

Exclusion Criteria:

• < 18 years old

• Absolute contraindications to MRI

• Type 1 diabetes (identified through C-peptide analysis)

• Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods

• Suffer from terminal illness

• Have impaired renal function (eGFR < 30 ml/min/1.73m2) )

• Impaired liver function (ALAT≥2.5 times upper limit of normal)

• Known to be Hepatitis B antigen or Hepatitis C antibody positive

• Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the investigator

• Recurrent major hypoglycaemia as judged by the investigator

• Known or suspected allergy to the trial products

• Known or suspected thyroid disease

• Receipt of any investigational drug within four weeks prior to this trial

• Have severe and enduring mental health problems

• Are not primarily responsible for their own care

• Are receiving insulin therapy

• Have taken a thiazolidinedione within the last 3 months

• Any contraindication to Sitagliptin or Liraglutide

• Have severe irritable bowel disorder

• Have pancreatitis or a previous history of pancreatitis