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

• Status: Completed
• Trial end date: 2017-10-30
• Target enrollment: 0
• Participant gender: All

Summary

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Satiogen Pharmaceuticals, Inc.
• Treatments: Bile Acids and Salts

Criteria

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.