Type 2 Diabetes MellitusPhase 1NCT01434901

The Effects of Bethanechol on Glucose Homeostasis

A Phase 1 study testing Bethanechol (25 mg), Bethanechol (50 mg) and Bethanechol (100 mg) in people with Type 2 Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Bethanechol (25 mg), Bethanechol (50 mg) and Bethanechol (100 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 15 Aug 2011to 7 Jul 2014
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

<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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63131

Other trials in United States

About this study

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

Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the intestine that are released into the blood immediately after ingestion of a meal. Together, these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by increasing acetylcholine release in pancreatic islets. This study will determine if a Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and reduces blood glucose levels after ingestion of a mixed meal.

Read the detailed description

Each eligible participant will be administered an oral glucose tolerance test (OGTT) so he/she can be assigned to the group with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) which is between normal and diabetic, or type 2 diabetes mellitus (T2DM). 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 placebo or Bethanechol (25 mg, 50 mg, or 100 mg) will taken by mouth 1 hour before ingestion of the meal. Blood samples will be collected before and during the MTT for the measurement of glucose, insulin, C-peptide, and glucagon levels.

Conditions: Type 2 Diabetes Mellitus
Being tested: Placebo, Bethanechol (25 mg), Bethanechol (50 mg), Bethanechol (100 mg)
Keywords: Diabetes, Blood Sugar, Xenin-25, GIP, Muscarinic
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
A placebo will be taken by mouth 1 hour before ingestion of a mixed meal.
Bethanechol (25 mg)Drug
25 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
Bethanechol (50 mg)Drug
50 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
Bethanechol (100 mg)Drug
100 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal

Study groups in NCT01434901
Study group	Role	What they receive
Normal Glucose Tolerance	Experimental	Healthy individuals exhibiting plasma glucose levels less than 140mg/dl two hours after ingestion of 75-g of glucose. Receives: Drug: Placebo; Drug: Bethanechol (25 mg); Drug: Bethanechol (50 mg); Drug: Bethanechol (100 mg)
Impaired Glucose Tolerance	Experimental	Healthy individuals exhibiting plasma glucose levels between 140 and 199 mg/dl two hours after ingestion of 75-g of glucose. Receives: Drug: Placebo; Drug: Bethanechol (25 mg); Drug: Bethanechol (50 mg); Drug: Bethanechol (100 mg)
Type 2 Diabetes Mellitus	Experimental	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. Receives: Drug: Placebo; Drug: Bethanechol (25 mg); Drug: Bethanechol (50 mg); Drug: Bethanechol (100 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

The effects of Bethanechol on insulin secretion rates
Insulin secretion rates (pmoles/min) will be calculated by deconvolution of plasma C-peptide levels. The investigators will then determine if post-prandial insulin secretion rates are greater following administration of Bethanechol compared to placebo.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 20117 Jul 2014

First posted15 Sep 2011 (estimated)
Study start15 Aug 2011
Primary completion7 Jul 2014
Study completion7 Jul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01434901
Sponsor's protocol ID: 08-0861C
Other IDs: 1R01DK088126-01
Status last verified: May 2018
First submitted: 10 Aug 2011
Last updated: 8 May 2018
Results posted: No
Data monitoring committee: Yes

Publications

Chowdhury S, Wang S, Dunai J, Kilpatrick R, Oestricker LZ, Wallendorf MJ, Patterson BW, Reeds DN, Wice BM. Hormonal Responses to Cholinergic Input Are Different in Humans with and without Type 2 Diabetes Mellitus. PLoS One. 2016 Jun 15;11(6):e0156852. doi: 10.1371/journal.pone.0156852. eCollection 2016.
PubMed 27304975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Bethanechol, a Muscarinic Agonist, on Plasma Insulin, Glucagon, and Glucose Levels in Humans With and Without Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01434901
Acronym / sponsor ID: 08-0861C
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, Blood Sugar, Xenin-25, GIP, Muscarinic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 15 Aug 2011 (actual)
Primary completion: 7 Jul 2014 (actual)
Study completion: 7 Jul 2014 (actual)
First posted: 15 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Normal Glucose Tolerance	Experimental	Drug: Placebo, Drug: Bethanechol (25 mg), Drug: Bethanechol (50 mg), Drug: Bethanechol (100 mg)Healthy individuals exhibiting plasma glucose levels less than 140mg/dl two hours after ingestion of 75-g of glucose.
Impaired Glucose Tolerance	Experimental	Drug: Placebo, Drug: Bethanechol (25 mg), Drug: Bethanechol (50 mg), Drug: Bethanechol (100 mg)Healthy individuals exhibiting plasma glucose levels between 140 and 199 mg/dl two hours after ingestion of 75-g of glucose.
Type 2 Diabetes Mellitus	Experimental	Drug: Placebo, Drug: Bethanechol (25 mg), Drug: Bethanechol (50 mg), Drug: Bethanechol (100 mg)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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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).

Key exclusion criteria (13 listed)

<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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboA placebo will be taken by mouth 1 hour before ingestion of a mixed meal.	Drug	Impaired Glucose Tolerance, Normal Glucose Tolerance, Type 2 Diabetes Mellitus
Bethanechol (25 mg)25 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal	Drug	Impaired Glucose Tolerance, Normal Glucose Tolerance, Type 2 Diabetes Mellitus
Bethanechol (50 mg)50 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal	Drug	Impaired Glucose Tolerance, Normal Glucose Tolerance, Type 2 Diabetes Mellitus
Bethanechol (100 mg)100 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal	Drug	Impaired Glucose Tolerance, Normal Glucose Tolerance, Type 2 Diabetes Mellitus

Primary outcome

The effects of Bethanechol on insulin secretion rates
Time frame: 3 years
Insulin secretion rates (pmoles/min) will be calculated by deconvolution of plasma C-peptide levels. The investigators will then determine if post-prandial insulin secretion rates are greater following administration of Bethanechol compared to placebo.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Results publication: PubMed 27304975Chowdhury S, Wang S, Dunai J, Kilpatrick R, Oestricker LZ, Wallendorf MJ, Patterson BW, Reeds DN, Wice BM. Hormonal Responses to Cholinergic Input Are Different in Humans with and without Type 2 Diabetes Mellitus. PLoS One. 2016 Jun 15;11(6):e0156852. doi: 10.1371/journal.pone.0156852. eCollection 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Burton M Wice, PhD principal investigator

Washington University School of Medicine

Dominic Reeds, MD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effects of Bethanechol on insulin secretion rates (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01434901, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.