Phase 2
Completed N=23
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
Type 2 Diabetes Mellitus · Obese · Overweight
Source: ClinicalTrials.gov NCT02871882 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Change in Postprandial Glucose — -2803; 629 mmol/6hr — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postprandial Glucose |
-2803; 629 | <0.05 sig |
Eligibility Criteria
Inclusion criteria
- Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
- Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.
Exclusion criteria
- Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
- Irritable bowel syndrome
- Bristol stool type classification 4-7 per Bowel Disease questionnaire.
- Subjects with other treatment for type 2 diabetes mellitus.
- Subjects with HbA1c > 8%
- Females who are pregnant or breastfeeding
- Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
- 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.
- Subjects who have donated blood or plasma in the past 8 weeks.
- Subjects who have participated in another study within the past 30 days.
Data sourced from ClinicalTrials.gov (NCT02871882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.