Ensayos clínicos

Inclusion Criteria

• Age 35-70 years
• Body Mass Index greater than 19kg/m^2 or less than 40kg/m^2 
• Total weight less than 130 kilograms
• Negative pregnancy test for women of childbearing potential
• Absence of gastrointestinal symptoms
• Signed informed consent
• Type 2 Diabetics, Treated with diet and/or metformin
  • Must be on stable therapeutic doses of metformin and/or lipid-lowering agents for more than 3 months

Exclusion Criteria

• Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders
  • A screening Bowel Disease Questionnaire will be used to exclude irritable bowel syndrome
  • History of dysphagia or intestinal motility disorders will be exclude
• Prior history of pancreatitis
• Prior history of hypertriglyceridemia (500mg/dL or greater)
• Currently using a bile-acid binding resin such as colesevelam, colestipol, colestimide or cholestyramine
• Insulin-treated type 2 diabetes mellitus, 
• Have received an inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), "gliptins" (a class of oral hypoglycemics), Byetta or a sulfonylurea agent in the past three months
• HbA1c greater than 9.0%
• Have not been stable on all medications for a period exceeding 3 months
• Use of drugs or agents within the past 2 weeks or planned use in the subsequent 4 weeks during the study period that:
  • Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRIs) and newer antidepressants.
  • Opiate-based analgesic drugs 
    • Intermittent or chronic use of aspirin or non-steroidal anti-inflammatory drugs (NSAID) will be allowed
  • Antihistamines
  • Anticholinergic agents
• Female subjects who are pregnant or breast-feeding
  • Females must be either surgically sterilized, postmenopausal (>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician
• Clinical evidence (including physical exam and Electrocardiogram) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interferes with the objectives of the study
  • Any candidate participants with such disorders mentioned will be referred to their general physician