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Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Placebo (Drug); Glucose-dependent Insulinotropic Polypeptide (GIP) (Drug); Xenin-25 (Drug); Glucose-dependent Insulinotropic Polypeptide plus Xenin-25 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Burton Wice, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Dominic Reeds, MD, Principal Investigator, Affiliation: Washington University School of Medicine


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.

Clinical Details

Official title: Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: The effects of GIP, xenin-25, or a combination of GIP plus xenin-25 on insulin secretion and blood glucose levels

Secondary outcome: We will develop an assay to measure the normal fasting and postprandial concentrations of endogenous xenin-25 and determine whether they are altered in T2DM.

Detailed description: Each eligible participant will be administered an oral glucose tolerance test so he/she can be assigned to the group with "normal glucose tolerance", "impaired glucose tolerance" (between normal and diabetic), or type 2 diabetes mellitus. Each study subject will then be administered a meal tolerance test (MTT) on 4 separate occasions. For the MTT, a liquid meal (Boost Plus)will be ingested following an overnight fast. A primed-continuous infusion of vehicle alone, GIP alone, xenin-25 alone, or the combination of GIP plus xenin-25 (each peptide at a dose of 4 pmoles x kg-1 x min-1) will be initiated at the same time the meal is ingested. Blood samples will be collected before and during the MTT for the measurement of glucose, insulin, C-peptide, glucagon, GIP and xenin-25 levels.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Ages 18-65. No minors will be studied.

- 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 (see below).

- Otherwise healthy volunteers that have impaired glucose tolerance (see below).

- Otherwise healthy volunteers with Diet Controlled T2DM (see below).

- Otherwise healthy volunteers with T2DM that take oral agents only and if the

subject's pre-existing oral anti-diabetic agents can be safely discontinued for 48 hours prior to Oral Glucose Tolerance Test.

- Otherwise healthy volunteers with T2DM who do not use insulin for blood glucose


- Persons with HbA1c ≤ 9%.

- Women of childbearing potential must be currently taking/using a method of birth

control that is acceptable to the investigators. 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 return have 8-10ml of blood drawn 25-30 days after the last Xenin

infusion; to check for Xenin peptide antibodies that MAY develop. (All efforts will be made to complete this visit during study participation. Exclusion Criteria:

- <18years of age or >65 years of age

- Lacks cognitive ability to sign the consent &/or follow the study directions for


- Women unwilling to comply with using 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 @ home

- Volunteers with a history of Acute Pancreatitis

- 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.

- Volunteers with a history of cancer. Exception: skin cancer.

- Diabetics that have the potential to have a low blood sugar without them being aware

that their blood sugar is low (hypoglycemia unawareness).

- Known heart, kidney. liver or pancreatic disease requiring medications.

- Subjects unwilling to allow the use of their own blood or the human albumin in the

preparation of the peptides.

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

Locations and Contacts

Washington University School of Medicine, St. Louis, Missouri 63110, United States
Additional Information

Starting date: October 2009
Last updated: July 21, 2014

Page last updated: August 23, 2015

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