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

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: Diabetes

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):
Dominic Reeds, MD, Principal Investigator, Affiliation: Washington University School of Medicine
Burton Wice, PhD, 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: Restoration of the GIP-mediated Incretin Effect in Persons With Type 2 Diabetes Mellitus

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: The effects of xenin-25 on GIP action in persons with type 2 diabetes

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 graded glucose infusion (GGI) on 4 separate occasions. For the GGI, an intravenous glucose infusion will be started at a rate of 1 mg x kg-1 x min-1 for 40 min, followed by 2, 3, 4, 6, and 8 mg x kg-1 x min-1 (40 min for each step). 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 glucose infusion is started. Blood samples will be collected before and during the GGI 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:

- 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


- 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: December 2008
Last updated: July 21, 2014

Page last updated: August 23, 2015

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