Comparing the effects of two new therapies for diabetes on the heart, measures of fat and diabetes in young people with type 2 diabetes

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 16.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002422-78-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

•Capacity to provide informed consent before any trial-related activities •Aged 18 – 50 years inclusive •Established T2DM (>12 months) •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 = 3 months •No prescribed thiazolidinediones within the last 3 months •An HbA1c value of >= 6.5% and <= 10%
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•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 •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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified