Type 2 Diabetes
Conditions
Interventions
Trade Name: Lyxumia®
Product Name: Lixisenatide
Product Code: SUB32251
Pharmaceutical Form: Solution for injection in pre-filled pen
INN
Sponsors
University of Surrey
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Subjects with type 2 diabetes inadequately controlled by metformin • Stable over last 3 months • Caucasian • Male • 40-65 years • HbA1c 7.5-8.5% • BMI 30-35 • Able and willing to self-administer placebo/lixisenatide injection • Able and willing to perform self-blood glucose monitoring. 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 14 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Subjects treated with insulin, any oral hypoglycaemic agents (OHA) other than metformin, any insulin secretagogues • A history of heavy alcohol use (>12 to 15 g of alcohol per day), • Arteriopathy • Hepatic disease-with ALT >3 times upper limit of normal • Renal disease-estimated glomerular filtration rate less than 40ml/minute. • Subjects receiving fibrates or weight reducing drugs, • Mental incapacity, • Unwillingness or a language barrier precluding adequate understanding or co-operation • Fasting plasma triglycerides >4.0 mmol/l • Blood pressure limits Systolic 3 times the upper limit of the normal laboratory range (ULN) and P-calcitonin =20 pg/ml (5.9 pmol/L). • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes). • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, • Allergic reaction to any GLP-1 receptor agonist or to metacresol. • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting. • Patients on beta blockers. • Smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary endpoint The total rate of glucose appearance following the breakfast meal at visits 3 and 7, measured as area under the curve (AUC) from 0-180 minutes and AUC from 0-240 minutes, where the meal is given at 0 minutes. ;Timepoint(s) of evaluation of this end point: 180 minutes and 240 minutes where the meal is given at 0 minutes.; Main Objective: 1. To investigate how Lixisenatide lowers blood glucose after feeding. ; Secondary Objective: 2. To investigate the effects of Lixisenatide on the contributions of fat coming from the intestine and fat coming from the liver to the raised levels of fat found in blood after feeding in patients with type II diabetes. 3. To investigate the effects of Lixisenatide on the rate at which food is absorbed from the gut. 4. To investigate the activity of a protein which is involved in fat breakdown. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints as above ; Secondary end point(s): Secondary endpoints At visits 3 and 7 • endogenous glucose production measured as AUC (0-180 minutes) and AUC (0-240 minutes) • rate of meal glucose appearance measured as AUC (0-180 minutes) and AUC (0-240 minutes) • glucose clearance rate measured as AUC (0-180 minutes) and AUC (0-240 minutes) • postprandial glycaemia measured as AUC (0-180 minutes) and AUC (0-240 minutes) • the rate of gastric emptying • post-heparin lipoprotein lipase activity At visits 4 and 8 • the production rate of chylomicrons • the production rate of VLDL • the clearance rate of chylomicrons • the clearance rate of VLDL • postprandial triglyceridaemia (AUC- visits 3 and 7; steady state TGs - visits 4 and 8) • energy intake measured by diet diary | — |
Countries
United Kingdom
Contacts
Public ContactChenery
University of Surrey
Outcome results
None listed