DRUG
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
Status
Active, not recruiting
Phase
Phase 4
Enrollment
23
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment. Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. The 2 weeks break without our medication will separate these phases. A very close observation regarding safety of our subjects will be implemented by study personnel and clinical investigators.
Full detailed description
The symptoms of chronic constipation are defined as infrequent bowel movements, hard stool, straining during defecation, bloating, abdominal discomfort, and sensation of incomplete evacuation. Constipation has been reported as a common complication of diabetic neuropathy. A new medication, called linaclotide, was studied on many patients, and it is approved to be on a market for constipated patients. Unfortunately diabetics were not included in these previous studies; hence we designed the project which is going to address the possible benefit of this drug in diabetic population.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 18, 2017
Study start
Sep 1, 2015
Primary completion
Oct 2026
Study completion
Jan 2027
Results posted
Not reported
Registry updated
Apr 3, 2026
Outcomes
What the study measures.
Primary outcomes
Improvement in frequency of bowel movements
Time frame · Up to 10 weeks
The primary outcome measure will indicate improvement in frequency of bowel movements (BMs) or not in a mean of available and recordered spontaneous BM (SBMs) over the 28 day treatment period compared to 28 days of placebo.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Linaclotide.
A Study of Virtual Reality and Linaclotide for IBS-C
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Not applicable
Recruiting
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2026-07
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
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Active, not recruiting
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2026-07
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
AbbVie · Functional Constipation (FC) · Chronic Idiopathic Constipation (CIC)
Phase 3
Completed
123
2026-05
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
University of Nottingham · Cystic Fibrosis (CF)
Early Phase 1
Recruiting
26
2026-05
GCC Agonist Signal in the Small Intestine
University of Wisconsin, Madison · Barrett Esophagus · Gastroesophageal Reflux Disease
Phase 1
Completed
43
2026-04
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Md Mehedi Shahriar · Chronic Idiopathic Constipation · Irritable Bowel Syndrome (IBS-C)
Phase 4
Not yet recruiting
90
2026-02
Linaclotide for Colonoscopy Bowel Prep
University of Florida · Patients Scheduled for Colonoscopy
Phase 1 / Phase 2
Recruiting
10
2026-01
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
AbbVie · Irritable Bowel Syndrome With Constipation · Functional Constipation
Phase 3
Completed
381
2026-01
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.