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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT01441232
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 65 years of age
* History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
* Body mass index (BMI) ≤45 kg/sq m
* Willing and able to self-monitor blood glucose
* Able to provide written informed consent
Exclusion Criteria:
* History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
* Current use of any blood glucose lowering agent other than metformin
* History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
* Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
* History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2
* History of clinically significant cardiac arrhythmias within 1 year of Day -2
* Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure
* Subjects with uncontrolled Stage 3 hypertension
* History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2
* History of alcohol or drug abuse within 12 months of Screening
* History of bowel resection \> 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying
* History of HIV or hepatitis C
* Major surgery within 3 months of Day -2 or any planned surgery during the study
* History of any active infection within 2 weeks of Day -2
* History of pancreatitis
* History of any malignancy within the last 5 years which would affect the diagnosis or assessment of LX4211 or sitagliptin
* History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin
* Presence of any clinically significant physical, laboratory, or ECG findings or any concurrent condition at Screening that may interfere with the study in the opinion of the investigator
* Triglycerides \> 1000 mg/dL at Screening or Day -2
* Donation or loss of \>400 mL of blood or blood product within 8 weeks prior to Day -2
* Use of any tobacco product for the duration of study participation
* Use of corticosteroids within 2 weeks of Day 1
* Use of digoxin or warfarin within 2 weeks prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01441232
Study Brief:
Protocol Section:
NCT01441232