Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Conjugated bile acids · 1 trial · 3 indications
Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal
| Arm | Type | Description |
|---|---|---|
| Ox bile extract | ACTIVE_COMPARATOR | Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests |
| Name | Type | Description |
|---|---|---|
| Gastric Emptying test | RADIATION | participants eat a standardized meal labeled with radioactive markers (99mTc DTPA \[diethylenetriaminepentaacetic acid\] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying. |
| Mixed Oral Glucose Tolerance test | OTHER | Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points. |
| Conjugated bile acids sodium | DRUG | 500 mg tablets taken orally twice daily for 28 (+/- 4) days |
| Placebo | OTHER | Placebo tablets taken orally twice daily for 28 (+/- 4) days |
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 receivi...