Efficacy of Welchol in Type 2 Diabetes

Significant A1C reductions

When added to preexisting anti-diabetic therapy, Welchol significantly lowered A1C.

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Welchol: Add-on therapy for patients with uncontrolled A1C

In the GLOWS pilot study (N=65), Welchol significantly reduced A1C, fasting plasma glucose, and postprandial glucose^† when added to preexisting anti-diabetic therapy.^*1

Primary endpoint: Placebo-adjusted mean change in A1C
Secondary endpoints included: Fasting plasma glucose and postprandial glucose fructosamine, LDL-C from baseline to week 12

The following data were based on a subgroup analysis determined prior to unblinding:

^†Results from a prospective, randomized, double-blind, placebo-controlled, parallel-group pilot study. Adult subjects (N=65) with A1C levels 7%-10% were included if they had type 2 diabetes that had been inadequately controlled on an anti-diabetic therapy. Patients were maintained on preexisting sulfonylurea and/or metformin therapy throughout the study. Primary endpoint was mean change in A1C from baseline to Week 12. Secondary endpoints included mean changes in fructosamine, FPG, PPG, and LDL-C from baseline to Week 12.
(*sulfonylurea, metformin, or both)

Welchol: Add-on therapy for consistent mean A1C and LDL-C reductions

In 3 pivotal studies, Welchol significantly reduced A1C and LDL-C when added to preexisting anti-diabetic therapy.^2-5

In these same studies, patients taking Welchol also achieved significant LDL-C reductions^5,6

Please see Study Designs A1, A2, A3

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.

Effective A1C and LDL-C reductions when added to one or more common anti-diabetic therapies

Welchol added to preexisting anti-diabetic monotherapy (metformin alone, sulfonylurea alone, or insulin alone) demonstrated further A1C and LDL-C lowering.^2-5

In these studies, patients taking Welchol also achieved significant
LDL-C reductions^5,6

Please see Study Designs A1, A2, A3

Welchol added to anti-diabetic combination therapies^† demonstrated further A1C and LDL-C lowering.^2-5

Welchol added to pre-existing anti-diabetic combination therapy (metformin, sulfonylurea, or insulin based multi-agent therapy) demonstrated further A1C and LDL-C lowering.

In these studies, patients taking Welchol also achieved significant
LDL-C reductions^5,6

^†Welchol has not been studied in combination with all anti-diabetic agents.

Please see Study Designs A1, A2, A3

*ACE = American College of Endocrinology; AACE = American Association of Clinical Endocrinologists

Welchol: A bile acid sequestrant for more than just primary hyperlipidemia

Patients with T2DM may have an altered bile acid metabolism⁹

• While the exact mechanism by which Welchol improves glycemic control is unknown, there is increasing evidence that bile acids play a role in glucose metabolism, in addition to lipid metabolism.¹⁰

Welchol is a specifically engineered bile acid sequestrant

• Welchol is a high-affinity, high-capacity bile-acid–binding molecule.¹¹

Clinical significance of in vitro data is unknown.

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.^2,5

Study Design A2 (Fonseca VA, Diabetes Care. 2008)

Results from a double-blind, 26-week, placebo-controlled pivotal study of 460 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting sulfonylurea-based therapy. Either Welchol or placebo was added to sulfonylurea alone or sulfonylurea 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.^3,5

Study Design A3 (Goldberg RB, Arch Intern Med. 2008)

Results from a double-blind, 16-week, placebo-controlled pivotal study of 287 randomized patients with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Patients were enrolled and maintained on their preexisting insulin-based therapy. Either Welchol or placebo was added to insulin alone or insulin in combination with other anti-diabetic therapies for 16 weeks. The primary efficacy endpoint was mean change in A1C from baseline; secondary endpoints included mean change in LDL-C from baseline.^4,5

Please see Important Safety Information about Welchol below