Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.; International Diabetes Center at Park Nicollet
• Treatments: Colesevelam Hydrochloride

Criteria

Inclusion Criteria:

• Male or female subjects ≥18 and ≤75 years of age

• Clinical diagnosis of type 2 diabetes

• Currently treated with metformin, a sulfonylurea, or combination metformin/sulfonylurea; stable dose for ≥3 months

• HbA1c of 7.0-9.0% inclusive

• If taking lipid lowering medications, stable dose for >30 days

Exclusion Criteria:

• Taken oral or injected prednisone or cortisone medications in the previous 30 days. (Topical or inhaled steroids will not be considered excluded medications.)

• Current use of insulin or TZD's, or incretins

• LDL <70 mg/dL

• Serum triglycerides >500 mg/dL

• History of hypertriglyceridemia-induced pancreatitis

• History of gastrointestinal disorder such as dysphagia, swallowing disorder, intestinal motility disorder or prior bowel obstruction

• History or presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study

• Unable to follow the study protocol

• Unable to speak, read and write in English

• Pregnant, planning to become pregnant, breast feeding