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

Clinical Trial Details

Overview

Research Study Summary

Uncontrolled Type II Diabetes`

Purpose

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
Phase

4

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Duration

28 Weeks

Facility Type

N/A

Contact

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

View Map

Research Center Information: Renstar Medical Research

CW ID: 154270

Date Last Changed: July 24, 2013


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