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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00949663

Type 2 Diabetes Mellitus

COMPLETED PHASE1

The Role of Cholinergic Signaling for Mediating the Effects of GIP and/or Xenin-25 on Insulin Secretion

NCT01951729

Pre-diabetes

COMPLETED PHASE1

Effects of Xenin-25 on Insulin Secretion and Gastric Emptying in Humans With and Without a Complete Truncal Vagotomy

NCT01951716

Does the Vagus Nerve Mediate the Effects of Xenin-25

WITHDRAWN PHASE1

The Effects of Bethanechol on Glucose Homeostasis

NCT01434901

Type 2 Diabetes Mellitus

COMPLETED PHASE1

The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes

NCT04228484

Type2 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal Glucose Tolerance

Healthy individuals exhibiting plasma glucose levels less than 140mg/dl two hours after ingestion of 75-g of glucose.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Intravenous infusion of 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide (GIP)

Intervention Type DRUG

Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Xenin-25

Intervention Type DRUG

Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide plus Xenin-25

Intervention Type DRUG

Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline

Impaired Glucose Tolerance

Healthy individuals exhibiting plasma glucose levels between 140 and 199 mg/dl two hours after ingestion of 75-g of glucose.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Intravenous infusion of 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide (GIP)

Intervention Type DRUG

Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Xenin-25

Intervention Type DRUG

Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide plus Xenin-25

Intervention Type DRUG

Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Intravenous infusion of 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide (GIP)

Intervention Type DRUG

Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Xenin-25

Intervention Type DRUG

Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Glucose-dependent Insulinotropic Polypeptide plus Xenin-25

Intervention Type DRUG

Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Intravenous infusion of 1% human albumin in normal saline

Intervention Type 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

Intervention Type DRUG

Xenin-25

Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vehicle alone GIP Xenin GIP plus Xenin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes