Phase 2 Completed N=24 Randomized Triple-blind Treatment

Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT02033876 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcomePrimary: Change in Area Above Basal (AAB) for Glucose — 66458; 72566 mg/dL x min — p=0.43

Summary

This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Area Above Basal (AAB) for Glucose	66458; 72566	0.43
SECONDARY Change in Fasting Glucose	142; 155.7	0.65
SECONDARY Change in Insulin Sensitivity	19983; 19086	—
SECONDARY Gastric Emptying of Liquids (T1/2)	63.2; 63.6	0.37
SECONDARY Gastric Emptying of Solids (T1/2)	167.5; 172.3	0.51
SECONDARY Change in Weight	93.6; 101.9	0.4
SECONDARY Change in Body Mass Index	33.1; 32.3	0.8
SECONDARY Change in FGF-19	52.2; 90.2	0.006 sig

Eligibility Criteria

Overweight or Obese subjects with BMI> 25 Kg/m2 with Type 2 Diabetes mellitus on Metformin, receiving standard of care for Type 2 DM. Otherwise individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than T2DM) and unstable psychiatric disease. Men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication.

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Data sourced from ClinicalTrials.gov (NCT02033876). 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.