Phase 3
Completed N=562
Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00789750 ↗Enrolled (actual)
562
Serious AEs
2.7%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 — -0.34; -0.02 percent — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 |
-0.34; -0.02 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 4 |
-0.28; -0.11 | <0.001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 8 |
-0.35; -0.14 | 0.0002 sig |
| SECONDARY Change From Baseline in HbA1c at Week 16 |
-0.50; -0.15 | <0.001 sig |
| SECONDARY Number of Participants Achieving an HbA1c Goal of <7.0% |
56; 35 | 0.012 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-4.8; 9.9 | <0.0001 sig |
| SECONDARY Number of Participants With a Decrease of >= 0.7 Percent in HbA1c |
108; 70 | 0.0003 sig |
| SECONDARY Number of Participants With a Decrease of >= 0.5 Percent in HbA1c |
147; 106 | <0.001 sig |
| SECONDARY Number of Participants With a Reduction in FPG of >= 30 mg/dL |
60; 47 | 0.132 |
| SECONDARY Percent Change From Baseline in Total Cholesterol (TC) |
-3.4; 3.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-9.1; 7.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) |
2.9; 1.1 | 0.1652 |
| SECONDARY Percent Change From Baseline in Non-HDL-C |
-5.2; 4.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides (TG) |
14.1; 2.2 | 0.0004 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I) |
3.2; -0.2 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B) |
-5.2; 3.6 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Insulin Levels |
0.2; 0.8 | 0.7286 |
| SECONDARY Change From Baseline in Fasting C-peptide |
0.1; 0.3 | 0.0653 |
| SECONDARY Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
0.2; 0.3 | 0.8862 |
Eligibility 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 = = 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
Data sourced from ClinicalTrials.gov (NCT00789750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.