Clinical Trial: An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
Brief Summary: The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
Detailed Summary:
Sponsor: XOMA (US) LLC
Current Primary Outcome:
- Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events - [ Time Frame: 42 days ]Safety assessed by treatment-emergent adverse events
- Single dose Part 1 - Change from baseline in glucose levels [ Time Frame: Baseline and 22 days ]Glucose measured using a continuous glucose monitor
- Single dose Part 1 - Blood glucose levels [ Time Frame: Daily through Day 11 and at Day 22 ]Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
- Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol [ Time Frame: 28 days ]Glucose measured by continuous glucose monitoring every 5 min
- Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol [ Time Frame: 28 days ]
Original Primary Outcome:
- Incidence of treatment-emergent adverse events [ Time Frame: 42 days ]Safety assessed by treatment-emergent adverse events
- Change from baseline in glucose levels [ Time Frame: Baseline and 22 days ]Glucose measured using a continuous glucose monitor
- Blood glucose levels [ Time Frame: Daily through Day 11 and at Day 22 ]Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Current Secondary Outcome:
Original Secondary Outcome:
Information By: XOMA (US) LLC
Dates:
Date Received: May 3, 2016
Date Started: April 2016
Date Completion: October 2017
Last Updated: February 2, 2017
Last Verified: February 2017