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Therapeutic Areas: Endocrinology | Family Medicine
Disease Category: Diabetes Mellitus, Type 2
Location: United States, FL

Clinical Trial Details


Research Study Summary

Uncontrolled Type II Diabetes`


This is a Phase 3b/4 randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of Welchol as an add-on to pioglitazone (Actos) therapy for patients with Type II DM. The study consists of 28 weeks with 8 office visits. You may be compensated for your time and travel upon completion of study.

Patient Inclusion Criteria:

  • Male/female age 18 and older
  • Diagnosed with DM II
  • Inadequate glycemic control on a stable dose (2 months prior to screening) of monotherapy with pioglitazone at 30 or 45 mg/day, with or without metformin or a sulfonylurea
  • A1c > 7.5% and < 9.5% at screening
  • Women of childbearing potential must be using adequate form of birth control throughout study and up to 4 weeks after study completion
  • Clinically stable medical conditions other than DM II
  • Stable dose of medications (concomitant) for at least 30 days, and will not need adjustment during study period

Patient Exclusion Criteria:

  • BMI >40 KG at screening, weight loss >3% in past 3 months prior to screen
  • History of insulin use >2 weeks during previous 3 months or total of >2 months insulin therapy prior to screening
  • LDL level <60 mg
  • History of DM I and/or history of ketoacidosis
  • Use of a bile acid sequestrant, including Welchol, within 3 months of screening
  • History of bowel obstruction, hypertriglyceride induced pancreatitis
  • History of dysphagia, swallowing disorders, gastroparesis, gastrointestinal disorders, major gastro surgery
  • History of unstable angina, MI, TIA, cerebrovascular accident, any revascularization within 6 months prior to screening
  • History of CA in the past 10 years-Women with history of cervical dysplasia (CIN2 or higher) excluded, unless 2 consecutive normal cervical smears have been recorded prior to enrollment
  • HIV positive
  • History of drug or alcohol abuse within 1 year
  • History of untreated major psychiatric disorder
  • Allergy hypersensitivity or intolerance to study medication
  • Participation in an interventional medical, surgical, or pharmaceutical study within 30 days

To Learn more



Both Male and Female


18 and up

Overall Status



28 Weeks

Facility Type



Renstar Medical Research
104 SE 1st Ave., Suite B
Ocala, FL 34471
Phone: 352-629-5800

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Research Center Information: Renstar Medical Research

CW ID: 154270

Date Last Changed: July 24, 2013

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