Phase 2
Completed N=36
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00147745 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. — -0.06; -0.011; -0.01 mg/kg/min — p=0.5499
Summary
This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment. |
-0.06; -0.011; -0.01 | 0.5499 |
| PRIMARY Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12. |
-0.08; -0.16; -0.04 | 0.2042 |
| PRIMARY Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose |
-38.4 | 0.0362 sig |
| SECONDARY The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks |
-49.1; -4.7; -59.3 | 0.4104 |
| SECONDARY Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks |
-0.29; 0.16; -0.81 | 0.2286 |
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 18 - 75, inclusive
- Diagnosed with type 2 diabetes
- Hemoglobin A1c value greater than or equal to 8.0%
- Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
- Overweight, obese (body mass index 25-45 kg/m2)
Exclusion Criteria
- Change of dose of lipid or blood pressure lowering therapy within past three months
- Previous treatment with colesevelam for hyperlipidemia
- Serum triglyceride greater than 500 mg/dL
- Serum low density lipoprotein-cholesterol less than 60 mg/dL
Data sourced from ClinicalTrials.gov (NCT00147745). 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.