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Efficacy of Welchol in Type 2 Diabetes
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Significant A1C reductions
When added to preexisting anti-diabetic therapy, Welchol significantly lowered A1C.
On this page:
- Welchol: Add-on therapy to improve glycemic control
- Make Welchol your preferred add-on therapy for additional A1C and LDL-C reductions
- Welchol: A bile acid sequestrant that goes beyond primary hyperlipidemia
- Welchol delivers efficacy without being systemically absorbed
- Study Design A1
- Study Design A2
Welchol: Add-on therapy to improve glycemic control
In the GLOWS pilot study, adding Welchol helped patients already on anti-diabetic therapy significantly reduce A1C, FPG, and PPG.1
The following data were based on a subgroup analysis determined prior to unblinding:
Make Welchol your preferred add-on therapy for additional A1C and LDL-C reductions
Welchol can help your adult patients with T2DM and primary hyperlipidemia achieve the additional A1C and LDL-C reductions they need.2-4
In a POST-HOC analysis of the Bays pivotal study...
Welchol + metformin combination therapy vs metformin combination therapy helped more patients achieve the ADA‡ and NCEP§ goals for A1C and LDL-C2,4,5,6
In this clinical trial, the most common adverse reaction observed by ≥5% of the subjects after receiving Welchol was constipation.
Contraindications
Welchol is contraindicated in individuals with bowel obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL, or with a history of hypertriglyceridemia-induced pancreatitis.
Welchol: A bile acid sequestrant that goes beyond primary hyperlipidemia
Increasing evidence suggests that bile acids may function as signaling molecules in the liver and GI tract for lipid and glucose metabolism.7
Welchol delivers efficacy without being systemically absorbed
Welchol binds to bile acids in the intestine without being metabolized by the liver and kidney
Welchol may increase triglyceride levels especially in patients on a sulfonylurea- or insulin-based therapy. Periodic monitoring of lipid parameters including TG and non–HDL-C levels is recommended. The long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain.
Study Designs
Study Design A1 (Bays HE, Arch Intern Med. 2008)
Results from a double-blind, 26-week, placebo-controlled pivotal study of 316 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting metformin-based therapy. Either Welchol or placebo was added to metformin alone or metformin in combination with other anti-diabetic therapies for 26 weeks. The primary efficacy endpoint was mean change in A1C from baseline; secondary endpoints included mean change in LDL-C from baseline.2,3
Study Design A2 (Post-hoc analysis of the Bays pivotal study)
This post-hoc analysis evaluated the percentages of patients achieving A1C and LDL-C goals. Of the total number of patients (N=69) in the Welchol + metformin combination therapy group, 17 patients (25%) achieved a reduction in A1C of <7% compared with 4 patients (5%) in the metformin combination therapy group (N=76). Additionally, 22 patients (37%) in the Welchol + metformin combination therapy group (N=59) and 8 patients (12%) in the metformin combination therapy group (N=65) achieved an LDL-C <70 mg/dL.4
Of the total number of patients (N=79) in the Welchol + metformin monotherapy group, 16 patients (20%) achieved a reduction in A1C of <7% compared with 5 patients (7%) in the metformin monotherapy group (N=76). Additionally, 17 patients (26%) in the Welchol + metformin monotherapy group (N=66) and 12 patients (20%) in the metformin monotherapy group (N=61) achieved an LDL-C <70 mg/dL.4
