The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Colesevelam; Placebo; Diet; Metformin
Intervention description: Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.; Three placebo tablets matching the active drug colesevelam in appearance, taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.; Subjects were instructed to follow a weight maintenance diet (~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period.; Subjects continued to take their pre-study therapeutic doses of metformin (Metformin 500mg tablets taken by mouth twice daily for a total daily dose of 1000 to 2000 mg) through the 12 week study period.
Intervention MeSH terms: Metformin; Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Incretins; colesevelam; hepatobiliary circulation

Summary:

      The goal of this study was to determine the metabolic mechanism for a certain type
      medication's ability to lower blood sugar after a meal in Type 2 Diabetics, in order to
      develop a better understanding of it's potential role in the treatment of obesity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 35-70 years old.

          -  Body Mass Index greater than 19kg/m^2 or less than 40kg/m^2 or a total weight less
             than 130 kilograms.

          -  Negative pregnancy test for women of childbearing potential.

          -  Absence of gastrointestinal symptoms.

          -  Signed informed consent.

          -  Treatment with diet and/or metformin. Subjects 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 subjects with irritable bowel syndrome. Patients with a history of
             dysphagia or intestinal motility disorders will be excluded.

          -  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.

          -  To ensure homogeneity between treatment groups we will exclude subjects with
             insulin-treated type 2 diabetes mellitus, subjects who have received an inhibitors of
             dipeptidyl peptidase 4 (DPP-4 inhibitors) or "gliptins" (a class of oral
             hypoglycemics), Byetta or sulfonylurea agent in the past three months.

          -  HbA1c greater than 9.0%.

          -  Patients who 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 (Note: 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 interfere with the objectives of the
             study. Any candidate participants with such disorders mentioned will be referred to
             their general physician.