Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT02049034
Eligibility Criteria:
Inclusion Criteria:
* Subjects with type 2 diabetes inadequately controlled by metformin.
* Stable diabetes management over last 3 months: metformin dose unchanged. HbA1c not known to have changed by \>0.5% over 3 months.
* Caucasian
* Male
* 40-65 years (inclusive)
* HbA1c 7.5-9.5% (inclusive)
* BMI 27-40 kg/m2 (inclusive)
* Able and willing to self-administer placebo/lixisenatide injection
* Able and willing to perform self-blood glucose monitoring.
* Able and willing to wear a Continuous Glucose Monitoring System (CGMS) for 3 days
Exclusion Criteria:
* Subjects treated with insulin, any oral hypoglycaemic agents (OHA) (other than metformin), any insulin secretagogue or Thiazolidinediones (TZDs)
* A history of heavy alcohol use (\>12 to 15 g of alcohol per day)
* Arteriopathy
* History of significant coronary artery disease (myocardial infarction, surgical or percutaneous \[balloon and/or stent\] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel)
* Ischemic cerebrovascular disease, including:
* History of ischemic stroke.
* History of carotid arterial disease as documented by ≥ 50 % stenosis documented by carotid ultrasound, magnetic resonance imaging or angiography, with or without neurological sequelae.
* Atherosclerotic peripheral arterial disease, as documented by history of amputation due to vascular disease; history of surgical or percutaneous revascularization procedure; current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index less than 0.9
* Hepatic disease: alanine transaminase (ALT) \>3 times upper limit of normal (ULN)
* Renal disease: estimated glomerular filtration rate (Cockroft-Gault equation) 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
* Systolic blood pressure \>160 mmHg on 2 occasions, measured at least 10-minutes apart
* Screening amylase and/or lipase \> 3 times ULN or 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.
* Any stomach/gastric surgery other than minor endoscopic procedures such as peptic ulcer injection
* Allergic reaction to any GLP-1 receptor agonist or to metacresol.
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting.
* Current smokers
* Subject enrolled in another experimental protocol which involves the use of an investigational drug or device
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02049034
Study Brief:
Protocol Section:
NCT02049034