Type 2 Diabetes Mellitus MedDRA version: 14.1 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) 6 mg/ml solution for injection in pre-filled pen
Product Code: EMEA/H/C/001026
Pharmaceutical Form: Injection
INN or Proposed INN: liraglutide
CAS Num
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals will be included into the trial if they meet the following criteria: • Capacity to provide informed consent before any trial-related activities • they are = 18 years old with established T2DM on metformin only or on dual therapy of metformin plus a sulphonylurea • with a HbA1c between 6.5 12% • Individuals intending to fast for a minimum of 10 consecutive days during the holy month of Ramadan 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Individuals will be unable to take part in the study if they; • Are pregnant or breast feeding • Suffer from terminal illness • Have significant renal or liver impairment • Are unable to provide informed consent • Have severe and enduring mental health problems • Are not primarily responsible for their own care • Are receiving insulin therapy • Have Type 1 Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to show that taking two diabetes therapies, Metformin and Liraglutide is more effective at helping people with established T2DM, who chose to fast during Ramadan, achieve better blood glucose control and maintain their body weight throughout this holy month in comparison to Metformin with another diabetes medication. Better blood glucose control includes either a reduction or no change in their HbA1c (long term blood glucose) levels and the elimination of severe hypoglycaemic events(an abnormally low blood glucose level) , requiring assistance from a third party.;Secondary Objective: We hypothesize that patients in the group taking Metformin and Liraglutide will have lower HbA1c levels, blood pressure, LDL cholesterol and triglycerides and a greater reduction in body weight and HDL cholesterol. Furthermore, the number of hospital admissions related to diabetic complications will be lower in this group. We additionally predict that treatment satisfaction and psychological outcomes will be better in the Metformin plus Liraglutide group compared to either of the other two treatment groups.;Primary end point(s): A triple composite endpoint of maintenance or improved HbA1c, maintenance of body weight and no severe hypoglycaemic events (defined as requiring a third party assistance with food only, glucagon or intravenous glucose - grade 3 hypoglycaemia) | — |
Countries
United Kingdom
Outcome results
None listed