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Phase 2 N=23 Randomized Triple-blind Treatment

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

Type 2 Diabetes Mellitus · Obese · Overweight

Bottom Line

View on ClinicalTrials.gov: NCT02871882 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Change in Postprandial Glucose — -2803; 629 mmol/6hr — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Gastric Emptying test (Radiation); Mixed Oral Glucose Tolerance test (Other); Conjugated bile acids sodium (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Oct 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Postprandial Glucose		 -2803; 629 <0.05 sig

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.

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.
View full record on ClinicalTrials.gov →

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.

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