Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

This is a single-center, placebo-controlled, parallel-group, single dose, randomized,
controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the
effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin
sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight
loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy
with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected
at defined times to measure glycemia, FGF-19 and incretins (GLP-1 [glucagon-like peptide-1],
OXM [oxyntomodulin], PYY 3-36 [peptide YY]) fasting levels and responses to the meal.

Inclusion criteria:

1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking
DPP4 inhibitors alone or in combination with metformin.

2. Women of childbearing potential will have a negative pregnancy test before initiation
of medication and within 48 hours of receiving radioisotope.

Exclusion criteria:

1. Structural of metabolic diseases/conditions that affect the gastrointestinal system,
or functional gastrointestinal disorders.

2. Irritable bowel syndrome

3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.

4. Subjects with other treatment for type 2 diabetes mellitus.

5. Subjects with HbA1c > 8%

6. Females who are pregnant or breastfeeding

7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or
lorcaserin.

8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal,
hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes
mellitus), and unstable psychiatric disease.

9. Subjects who have donated blood or plasma in the past 8 weeks.

10. Subjects who have participated in another study within the past 30 days.