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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone; Drug: Placebo; Drug: Colesevelam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789750

WEL-A-U306

Details and patient eligibility

About

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.

Enrollment: 562 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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562 participants in 2 patient groups, including a placebo group

Colesevelam

Experimental group

Description:

Participants receive six colesevelam tablets (3.8 grams/day) in addition to pioglitazone-based therapy (30 mg or 45 mg)

Treatment:

Drug: Colesevelam

Drug: Pioglitazone

Placebo

Placebo Comparator group

Description:

Participants receive six placebo tablets in addition to pioglitazone-based therapy (30 mg or 45 mg)

Treatment:

Drug: Placebo

Drug: Pioglitazone