Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

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

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Pioglitazone

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 diabetes mellitus

• Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications [metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor]

• Hemoglobin A1c (HbA1c) >= 7.5% and =< 9.5% at screening

• Fasting plasma glucose =<240 mg/dL at randomization (Week 0/Day 1).

• Male or female >= 18 years of age.

• Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol

• Fasting C-peptide level >0.5 ng/mL at screening

• Clinically stable in regards to medical conditions other than type 2 diabetes

• Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period

Exclusion Criteria:

• History of Type 1 diabetes and/or history of ketoacidosis

• History of bowel obstruction

• History of hypertriglyceridemia-induced pancreatitis

• Fasting serum triglyceride concentration >500 mg/dL

• History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery

• History of insulin use >= 2 weeks duration during the previous 3 months or a total of >2 months insulin therapy at any time prior to screening

• Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening

• Female subject who is pregnant or breastfeeding

• History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening