Clinical Trials

Inclusion Criteria:

- Patient must have given institutional consent for minimal risk studies.

- Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date
Parameters of Diabetes Mellitus (PDM)].

- Patient must have index weight and left-window weight values available in electronic
medical record (EMR).

- Patient must have hyperglycemia and/or diabetes as one of the following ≤90 days prior
to randomization (all glycemic parameters, except for HbA1c, must be measured in an
outpatient setting):

A. Glycated hemoglobin (HbA1c) ≥ 6.5%

OR

B. Any (2) PDMs on consecutive (≤90 days between PDMs) or simultaneous testing:

- Fasting Blood Glucose (FBG) ≥126 mg/dl

- Glycated hemoglobin (HbA1c) ≥ 6.5%

- Random Blood Glucose (RBG) ≥200 mg/dl

- 2 hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test
(OGTT)

OR

C. Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the
index PDM date

- Patient must have ≥1 glycemic parameter measured in the past 91-548 days prior to the
index PDM date (Left Window) without meeting inclusion criteria A, B, or C.

Exclusion Criteria:

- Patient has declined institutional consent for minimal risk studies.

- Patient must not have any known past history of hyperglycemia and/or diabetes as
defined by inclusion criteria A, B, or C

*Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.

- Patient must not be on active treatment for cancer, carry a current diagnosis of any
cancer, and/or investigated for suspicion of recurrence of past cancer (except
non-melanoma skin cancer or carcinoma in-situ of the cervix).

*Ongoing work up for suspicion of pancreatic cancer is not an exclusion.

- Patient must not have had a definitive diagnosis of pancreatic cancer prior to index
PDM date.

- Patient must not be on any anti-diabetes medications prior to index PDM date.

- Patient must not be on chronic or acute use of steroid medications ≤90 days prior to
the index PDM date.

*Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

- Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the
index PDM date.