Status:
COMPLETED
Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 monothera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT00789750
Start Date
April 1 2009
End Date
July 1 2012
Last Update
June 26 2017
Active Locations (141)
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1
Birmingham, Alabama, United States, 35205
2
Birmingham, Alabama, United States, 35216
3
Birmingham, Alabama, United States, 35294
4
Montgomery, Alabama, United States, 36106