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Could a common constipation drug help diabetics?

NCT ID NCT03119584

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether linaclotide (Linzess) can improve bowel movement frequency in people with type 2 diabetes who have chronic constipation. About 23 participants will receive either the drug or a placebo for two weeks, then switch after a break. The goal is to see if the drug safely increases spontaneous bowel movements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linaclotide (Linzess)
What this could lead to
If it works, this could provide a safe, effective option for relieving chronic constipation in people with type 2 diabetes.
What could go wrong
This is a small, early-phase trial with only 23 participants, so results may not apply to everyone. The drug may cause side effects like diarrhea or abdominal pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

23 people

The number who actually took part.

Started

Sep 2015

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Type II diabetics. * Functional Constipation defined by Rome III criteria are as follows: a. At least a 6 months history of constipation. b. Less than three spontaneous bowel movements (SBMs) per week. c. At least 25% of stools are lumpy or hard stools as it is described in Bristol Stool Form Scale (BSFS) less than score of 6. d. Sensation of incomplete evacuation following at least 25% of bowel movements. e. Straining on at least 25% of defecations. f. Sensation of anorectal obstruction/blockage for at least 25% of defecations. Note: The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study. * For patients' ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy or double-contrast barium enema, performed within the previous 5 years, based on the American Gastroenterological Association guidelines. * Patients with confirm diagnosis of Diabetic Autonomic Neuropathy based on results of ANX 3.0, real-time ANS monitoring system will be included in this investigation. * Patients diagnosed with diabetic peripheral neuropathy and/or symptoms of functional gastroduodenal disorders, such as GERD and functional dyspepsia may participate in a study. Exclusion Criteria: * Pregnancy or lactation * Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after study termination. * Loose or watery stools reported in the absence of laxatives for \>25% of BMs during the screening period by using Bristol Stool Form Scale (BSFS). * Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents) and chronic laxative use during the trial. * Patients diagnosed with severe, drug refractory gastroparesis (persistent daily vomiting), currently receiving parenteral feeding (N-G, J-G-Tubes), having history of frequent hospitalizations, or being implanted with gastric neurostimulation system. * Use of any of the following drugs within 3 days prior randomization and during the trial: a. Prokinetic agents (domperidone, metoclopramide, erythromycin). b. Medication containing opiates. c. Anti-spasmodic (e.g. Atropine, hyoscamine, scopolamine, glycopyrrolate). * Hemoglobin A1c\>8.2 * Use of illegal drugs. * Regular consumption of more than 2 drinks of alcohol per day * Chronic, more than 3/week use of NSAIDs. * Patients with prolonged straining/push during BMs suggesting severe pelvic floor dysfunction. * History or current diagnosis of diverticulitis and severe hemorrhoids. * History of gastric resections, partial colon resection, history of rectocele. * Existence of any major medical condition such as malignancy, severe renal and liver diseases, which in the decision of PI should be excluded from participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.