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:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT01373450
Eligibility Criteria:
Inclusion Criteria:
* Have a body mass index (BMI) of ≤38.0 kg/m\^2
* Have a clinical diagnosis of Type 2 diabetes mellitus
* Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L)
* Judged to be in good health
Exclusion Criteria:
* Have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* Have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
* Have untreated hypertension with blood pressure of \>160/95 mmHg
* Have a history of neoplastic disease within the past 5 years
* Have a history of hypersensitivity to OXM, liraglutide, insulin or Haemaccel®
* Unable or unwilling to comply with restrictions around concomitant medications
* Consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily
* Have had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
* Have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
* Are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet \<100 grams per day of carbohydrate)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01373450
Study Brief:
Protocol Section:
NCT01373450