Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function
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ClinicalTrials.gov Identifier: NCT00949663 |
Recruitment Status :
Completed
First Posted : July 30, 2009
Last Update Posted : July 22, 2014
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus | Drug: Placebo Drug: Glucose-dependent Insulinotropic Polypeptide (GIP) Drug: Xenin-25 Drug: Glucose-dependent Insulinotropic Polypeptide plus Xenin-25 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Normal Glucose Tolerance
Healthy individuals exhibiting plasma glucose levels less than 140mg/dl two hours after ingestion of 75-g of glucose.
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Drug: Placebo
Intravenous infusion of 1% human albumin in normal saline
Other Name: Vehicle Alone Drug: Glucose-dependent Insulinotropic Polypeptide (GIP) Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP Drug: Xenin-25 Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: Xenin Drug: Glucose-dependent Insulinotropic Polypeptide plus Xenin-25 Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP plus Xenin |
Experimental: Impaired Glucose Tolerance
Healthy individuals exhibiting plasma glucose levels between 140 and 199 mg/dl two hours after ingestion of 75-g of glucose.
|
Drug: Placebo
Intravenous infusion of 1% human albumin in normal saline
Other Name: Vehicle Alone Drug: Glucose-dependent Insulinotropic Polypeptide (GIP) Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP Drug: Xenin-25 Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: Xenin Drug: Glucose-dependent Insulinotropic Polypeptide plus Xenin-25 Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP plus Xenin |
Experimental: Type 2 Diabetes Mellitus
Healthy individuals exhibiting plasma glucose levels greater than 150 mg/dL under fasting conditions OR greater than 199 mg/dl two hours after ingestion of 75-g of glucose.
|
Drug: Placebo
Intravenous infusion of 1% human albumin in normal saline
Other Name: Vehicle Alone Drug: Glucose-dependent Insulinotropic Polypeptide (GIP) Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP Drug: Xenin-25 Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: Xenin Drug: Glucose-dependent Insulinotropic Polypeptide plus Xenin-25 Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
Other Name: GIP plus Xenin |
- The effects of GIP, xenin-25, or a combination of GIP plus xenin-25 on insulin secretion and blood glucose levels [ Time Frame: 3 years ]
- 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. [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 control.
- 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 themselves
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949663
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Burton Wice, PhD | Washington University School of Medicine | |
Principal Investigator: | Dominic Reeds, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00949663 |
Other Study ID Numbers: |
08-0861B 1R01DK088126-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 30, 2009 Key Record Dates |
Last Update Posted: | July 22, 2014 |
Last Verified: | July 2014 |
Diabetes Blood Sugar Xenin-25 GIP Insulin |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Gastric Inhibitory Polypeptide |
Gastrointestinal Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |