Efficacy in Type 2 Diabetes

Efficacy of Welchol in Type 2 Diabetes

In patients on preexisting antidiabetic (AD) monotherapy, Welchol™ (colesevelam HCl) achieved additional mean A1C reductions of 0.8%, 0.5%, and 0.6% when added to preexisting monotherapy with a sulfonylurea, metformin, or insulin, respectively.*

Welchol + preexisting sulfonylurea monotherapy:
Additional mean A1C reduction

p<0.001
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 26-week, double-blind, placebo-controlled pivotal trial of patients (n=460) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.8% when added to preexisting sulfonylurea monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.

• No washout period — ie, no discontinuation of preexisting type 2 diabetes therapy

Welchol is the first and only therapy approved to reduce both A1C and LDL-C

*Results from 3 double-blind, placebo-controlled pivotal trials of patients (n=1018) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved the following mean A1C reductions with preexisting AD therapy: metformin (0.5%, n=316), a sulfonylurea (0.8%, n=460), or insulin (0.6%, n=287). Patients were enrolled and maintained on their preexisting type 2 diabetes therapy. Either Welchol or placebo was added to a sulfonylurea or metformin for 26 weeks or to insulin for 16 weeks.

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 + preexisting metformin monotherapy

In patients on preexisting antidiabetic (AD) monotherapy, Welchol achieved a significant additional mean A1C reduction of 0.5% when added to metformin.

Welchol + preexisting metformin monotherapy:
Additional mean A1C reduction

p=0.002
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 26-week, double-blind, placebo-controlled pivotal trial of patients (n=316) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.5% when added to preexisting metformin monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.

Welchol is the first and only therapy approved to reduce both A1C and LDL-C

Welchol + preexisting insulin monotherapy

In patients on preexisting antidiabetic (AD) monotherapy, Welchol achieved an additional mean A1C reduction of 0.6% when added to insulin.

Welchol + preexisting insulin monotherapy:
Additional mean A1C reduction

p<0.001
†Represents the treatment difference of Welchol reductions minus placebo reductions

Result from a 16-week, double-blind, placebo-controlled pivotal trial of patients (n=287) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved a mean A1C reduction of 0.6% when added to preexisting insulin monotherapy. Patients were enrolled and maintained on their preexisting type 2 diabetes therapy.

Welchol in hard-to-treat patients

With preexisting antidiabetic (AD) monotherapy and combination therapy, Welchol achieved consistent and significant additional mean A1C reductions of 0.5% with a sulfonylurea, metformin, or insulin alone and in combination with other ADs.¹

Welchol + preexisting AD therapy:
Additional mean A1C reductions

†Represents the treatment difference of Welchol reductions minus placebo reductions

Results from 3 double-blind, placebo-controlled pivotal trials of patients (n=1018) with inadequate glycemic control (baseline A1C ≥7.5% and ≤9.5%). Welchol achieved the following mean A1C reductions with preexisting AD monotherapy: a sulfonylurea (0.8%, n=69), metformin (0.5%, n=79), or insulin (0.6%, n=54). Welchol achieved the following mean A1C reductions with preexisting AD combination therapy that included: a sulfonylurea (0.4%, n=149), metformin (0.6%, n=69), or insulin (0.4%, n=90). Welchol achieved the following mean A1C reductions with preexisting AD monotherapy and combination therapy: metformin (0.5%, n=144), a sulfonylurea (0.5%, n=218), or insulin (0.5%, n=144). Patients were enrolled and maintained on their preexisting type 2 diabetes therapy. Either Welchol or placebo was added to a sulfonylurea or metformin, alone and in combination with other AD therapy, for 26 weeks or insulin, alone and in combination with other AD therapy, for 16 weeks.

Welchol provided consistent and sustained mean A1C reductions

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