The effect of lixisenatide on blood sugar and fat during feeding in patients with type 2 diabetes.

Phase 1

• Conditions: Type 2 Diabetes; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-002826-22-GB
• Lead Sponsor: niversity of Surrey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-08
• Study Completion: 2016-01-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8

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

•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 <160 mmHg
•Laboratory findings at the time of screening, including amylase and/or lipase > 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

Study & Design

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