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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02647320
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written informed consent and adhere to the study visit schedule and treatment
* Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
* Male or female ≥ 18 and ≤ 70 years of age
* Screening fasting C-peptide \> 0.5 ng/mL
* Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
* WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit \[βhCG\]) before entering the Lead-in Period
* Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit
* On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day
* Screening HbA1c ≥ 7.0% and ≤ 10%
* Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period
Exclusion Criteria:
* History of type 1 diabetes and/or history of ketoacidosis
* History of insulin use for \> 2 weeks within 2 months prior to the Screening Visit
* Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) \> 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of \> 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
* Screening hemoglobin \<12 g/dL for males and \<11 g/dL for females
* Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
* Subjects after bariatric surgery or any gastric bypass
* Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )
* Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2.0 x upper limit of normal (ULN), and/or total bilirubin \> 1.5 x ULN. If a subject has total bilirubin \> 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled
* Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) \< 50 mL/min for both males and females
* Screening Creatine kinase (CK) \> 3.0 × ULN
* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
* History of congestive heart failure (CHF)
* Exclusionary concomitant medications:
a. Eight weeks prior to screening and throughout the duration of the study:
* Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.
* Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.
* Rosuvastatin \> 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)
* Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)
* Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)
* Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year
* Any history of a malignancy other than basal cell carcinoma within the past 5 years
* Pregnancy or breast-feeding, or intent to become pregnant during the study period
* Known (or evidence of) infection with human immunodeficiency virus
* Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest
* Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
* A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02647320
Study Brief:
Protocol Section:
NCT02647320