A Single-Dose Open-Label of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:5/20/2016
Start Date:April 2016
End Date:October 2016
Contact:Ann Neale
Phone:510-204-7515

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The purpose of this study is to evaluate the safety and clinical pharmacology of a single
dose of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.


Inclusion Criteria:

- Aged at least 18 years of age

- Weight ≥ 60 kg and ≤ 120 kg and Body Mass Index < 35 kg/m2 at baseline

- Received gastric bypass surgery more than 1 year before dosing

- Occurrence of postprandial hypoglycemia during the baseline period assessments

Exclusion Criteria:

- History of type 1 diabetes

- Planned use of the following medications on or after Day -3:

- Any agent for hypoglycemia, such as diazoxide or octreotide

- Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas,
SGLT2 inhibitors, and GLP-1 agonists

- Systemic glucocorticoids or β agonists that may affect glucose metabolism

- Long-acting somatostatin analogs or glucose-affecting medications

- Major general surgery within 3 months before study entry or anticipated during the
study period

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
2
sites
1524
mi
from 91732
Rochester, MN
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2301
mi
from 91732
Baltimore, MD
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