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CompletedPhase 1

The Effects of Bethanechol on Glucose Homeostasis

The Effects of Bethanechol, a Muscarinic Agonist, on Plasma Insulin, Glucagon, and Glucose Levels in Humans With and Without Type 2 Diabetes Mellitus

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

50

actual

Study population

Healthy volunteers, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criteria

HbA1c ≤9%Healthy volunteers

Primary endpoint

C-peptide AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01434901
Org study ID08-0861C
Secondary ID1R01DK088126-01

Timeline

Milestones

Study start2011-08-15actual
Study first posted2011-09-15estimated
Primary completion2014-07-07actual
Study completion2014-07-07actual
Last update posted2018-05-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

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.
Unwillingness to allow blood glucose level adjustment (if needed) with IV insulin.
Subjects with hyperthyroidism, coronary artery disease, peptic ulcer, asthma, chronic bronchitis, or COPD.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

The effects of Bethanechol on insulin secretion rates

Time frame:3 years

C-peptide AUC

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.