Study of the Effects of Xenin-25 in Humans With and Without Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released into the blood immediately after ingestion of a meal and plays an important role in regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This study is being conducted to determine whether a hormone called xenin-25 can restore the activity of GIP in persons with T2DM.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Gastric Inhibitory Polypeptide

Criteria

Inclusion Criteria:

• Individuals must be able to consent for their own participation (no mental impairment affecting cognition or willingness to follow study instructions).

• Healthy volunteers with no clinical evidence of T2DM.

• Otherwise healthy volunteers that have impaired glucose tolerance.

• Otherwise healthy volunteers with diet controlled T2DM.

• Otherwise healthy volunteers with T2DM that take oral agents only if the subject's pre-existing oral anti-diabetic agents can be safely discontinued for 48-hours.

• Persons with HbA1c less than 9%.

• Women of childbearing potential must be currently taking/using an acceptable method of birth control. A pregnancy test will be done at the beginning of each visit. Any woman with a positive pregnancy test will be removed from the study.

• Willingness to complete all required visits.

Exclusion Criteria:

• Lacks cognitive ability to sign the consent or follow the study directions.

• Women unwilling to use an acceptable method of contraception during the course of the study, or who are currently breast-feeding.

• Any subject whose screening HbA1c is >9.0%.

• Type 2 diabetes requiring the use of supplemental insulin at home.

• Volunteers with a history of Acute Pancreatitis.

• Volunteers with a history of cancer (except for skin cancer).

• Volunteer with a history of Chronic Pancreatitis and/or risk factors for chronic pancreatitis including hypertriglyceridemia (triglycerides >400mg/ml) hypercalcemia (blood calcium level >11.md/dl) and/or the presence of gallstones.

• Volunteers with a history of gastrointestinal disorders, particularly related to gastric motility/emptying such as gastric bypass, documented gastro-paresis in diabetic volunteers.

• Subjects taking medications known to affect glucose tolerance.

• Hematocrit from the lab is below 33% (or if the finger stick hemoglobin measured with the HemoCue 201+ is <11.2% mg/dlL).

• Diabetics that have the potential to have a low blood sugar without them being aware that their blood sugar is low (hypoglycemia unawareness).

• Significant systemic illness including heart, kidney, inflammatory, liver, or malignant disease requiring medications.

• Subjects will be excluded if their liver or kidney function is outside the upper limits of normal by > 3%. Total Bilirubin levels should be <2.

• Subjects unwilling to allow the use of human albumin in the preparation of the peptides.

• Unwillingness to allow blood glucose level adjustment (if needed) with IV insulin