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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01452451
Eligibility Criteria:
Inclusion Criteria:
* Is male or female and 18 to 65 years of age, inclusive, at screening
* Has a history of T2DM and a stable dose of metformin
* Has HbA1c levels at screening between 7% and 10%
Exclusion Criteria:
* Is pregnant or lactating
* Has type 1 diabetes
* Has a significant change in body weight in the 3 months before screening
* Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
* Has an estimated glomerular filtration rate rate \<75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 \<estimated glomerular filtration rate \<90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio \>30 mg/g.
* Has alanine aminotransferase or aspartate aminotransferase values \>2.0 × upper limit of normal or total bilirubin \>1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
* Has fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) or \>250 mg/dL (\>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
* Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
* Has any acute illness within 5 days before first study drug administration
* Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
* Is a heavy tobacco user(more than 10 cigarettes a day)
* Is a heavy alcohol user
* Has a positive screen for drugs of abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01452451
Study Brief:
Protocol Section:
NCT01452451