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
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza (9660) 6mg/ml solution for injeciton in pre-filled pen
Product Code: EMEA/H/C/001026
Pharmaceutical Form: Inje
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal question is whether Lirgalutide improves cardiac function (as measured by left-ventricular function) to a greater extent than Sitagliptin in younger adults with type 2 diabetes who are likely to present with abnormalities.;Secondary Objective: Secondary research ojecticves include: 1) Liraglutide therapy leads to greater improvements in the composite outcome of HbA1c <7.0%, no weight gain and no major or minor hypoglycaemiac compared to Sitagliptin 2)Liraglutide therapy leads to greater reductions in HbA1c compared to Sitagliptin 3)Liraglutide therapy leads to greater weight loss compared to Sitagliptin 4)Liraglutide therapy leads to improved endothelial function compared to Sitagliptin 5)Liraglutide therapy leads to greater renal sodium excretion compared to Sitagliptin 6)Liraglutide therapy does not increase baroreflex sensitivity and heart rate variability compared with Sitagliptin 7)Liragludite therapy leads to improved cardiorespiratory fitness ccompared to Sitagliptin 8)Liraglutide therapy is associated with improved quality of lifestyle and treatment satisfaction compared to Sitagliptin;Primary end point(s): The primary outcome measure for this study is change in left ventricular diastolic dysfunction at 26 weeks (6 months)post intervention. This will be determined by peak end diastolic strain rate measured via tagged cardiac MRI - the gold standrad technique.;Timepoint(s) of evaluation of this end point: Cardiac MRI will be preformed at baseline (time-point -2 weeks) and at 26 weeks (6 months) follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are a host of secondary outcomes which are listed below 1) Other measures of cardiac function: • Peak Systolic Strain • Left Ventricular Ejection Fraction • stroke volume • LV end-diastolic volume • LV end-systolic volume • LV end-diastolic mass • Left Ventricular End Diastolic Mass/volume ratio • Pre-and post contrast T1 mapping to calculate volume of distribution, a marker of diffuse cardiac fibrosis • Myocardial Perfusion Reserve ( a measure of microvascular function) Biochemical variables • HbA1c, • Liver Function Tests • plasma vitamin D • Lipid profile including total-, LDL- and HDL-cholesterol and triglycerides • Thyroid function tests Albuminuria and microalbuminuria • Urine Sodium and biocarbonate excretion Inflammatory variables • Interleukin-6 • C-reactive protein • Leptin • Adiponectin Anthropometric variables • BMI • Weight • Percentage body fat • Waist Circumference • Systolic and Diastolic Blood pressure • Heart rate (after resting seated for • at least 5 minutes) • Heart Rate Variability (HRV) via spectral analysis Endothlial function • Serum ICAM-1 measurement MRI defined adiposity • Subcutaneous, visceral and hepatic adiposity volumes (measured through semi-automated analysis) Quality of life and depression • EQ5D • Hospital anxiety and depression score (HADS) Treatment satisfaction • DTSQ Medication usage Hypoglycemia - self-reported in a standardized hypoglycemia diary. Participants will be enabled to self-monitor their glucose levels throughout the course of the trial And other adverse events;Timepoint(s) of evaluation of this end point: Data collection takes place at the following time-points -2,2,4,6,9,12,17,21 and 26 weeks. However not all data collected at baseline (-2 weeks)is repeated at these follow-up seesions as detailed below; Standard biochemical variables at time point -2,9,12,17,21 and 26 weeks Inflammation at time points -2,12 and 26 weeks Anthropometric at time points -2,2,4,6,9,12, | — |
Countries
United Kingdom
Contacts
Public ContactMelanie Davies
University of Leicester
Outcome results
None listed