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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00789750

Run by

Daiichi Sankyo

People needed

562

Starts

2009-04-01

Expected to finish

2012-07-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Green Valley, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Searcy, Arkansas, United States
• Study site — Buena Park, California, United States
• Study site — Burbank, California, United States
• Study site — Chino, California, United States
• Study site — Garden Grove, California, United States
• Study site — Huntington Park, California, United States
• Study site — La Mirada, California, United States
• Study site — Lincoln, California, United States
• Study site — Lomita, California, United States
• Study site — Los Gatos, California, United States
• Study site — Modesto, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Tustin, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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