Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

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.