TYPE 2 DIABETES MELLITUS
Conditions
Interventions
Trade Name: VICTOZA
Product Name: LIRAGLUTIDE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
CAS Number: 2
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female • Aged between 18-70 years • =12 months after gastric bypass or sleeve gastrectomy bariatric surgery • Diagnosed with Type 2 diabetes mellitus according to WHO 2006 and 2011 criteria • HbA1c >6.5% (>48 mmol/mol) on screening • On Metformin ± long acting insulin • Able to give informed consent 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Diagnosed with Type 1 diabetes mellitus • Anatomical or endocrinological pathology causing poor weight loss or weight regain • Screening calcitonin of 50 ng/L or above • Family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma • Personal history of non-familial medullary thyroid carcinoma • History of acute or chronic pancreatitis • Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above) • Estimated glomerular filtration rate (eGFR) <30 ml/min • 1.73 m2). • Current pregnancy. • Inability to maintain adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Will liraglutide improve diabetes in patients who have not responded as well to surgery for obesity and diabetes?; Secondary Objective: We also want to find out whether giving patient who do not do well after surgery a daily injection of GLP-1 may also affect their: • body weight • systolic and diastolic blood pressure • total number of medications • insulin dose for those patients taking insulin as treatment for T2DM. • obesity-related comorbidities staging score • quality of life • total caloric intake and macronutrient composition • behavioural traits, ad libitum total food intake, sweet taste detection threshold, consummatory taste reward ratings, and wanting and liking for food pictures • number of hypoglycaemic episodes • adverse events ;Primary end point(s): HbA1C reduction from baseline;Timepoint(s) of evaluation of this end point: 26 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): change from baseline in: • body weight • systolic and diastolic blood pressure • total number of medications • insulin dose for those patients taking insulin as treatment for T2DM. • obesity-related comorbidities staging score • quality of life • total caloric intake and macronutrient composition • behavioural traits, ad libitum total food intake, sweet taste detection threshold, consummatory taste reward ratings, and wanting and liking for food pictures • number of hypoglycaemic episodes • adverse events ;Timepoint(s) of evaluation of this end point: 24 WEEKS | — |
Countries
United Kingdom
Contacts
Public ContactALEXANDER MIRAS
IMPERIAL COLLEGE LONDON
Outcome results
None listed