Data from Pooled Analyses Demonstrates Welchol, Combined with Metformin- or Sulfonylurea-Based Therapy, Significantly Lowers Blood Glucose in Adults with Type ...(sity Health Sciences Center a principali...),Health

Several mechanisms have been proposed for the glucose-lowering effect of Welchol, including reductions in glucose absorption and effects on glucose metabolism via nuclear receptors in the intestine and/or the liver. The exact mechanism(s) is under investigation and remains to be confirmed.

About the Analyses

A pooled analysis evaluated 696 patients on metformin-based therapy (monotherapy or combination with other antidiabetes agents) who received add- on treatment with Welchol 3.75 g/day (n=355) or placebo (n=341). Efficacy endpoints in this analysis included change from baseline in A1C and fasting plasma glucose (FPG). Lipids and weight were not analyzed in this pooled analysis, however, LDL-C was significantly reduced in each of the primary studies (P<0.001 vs. placebo). Weight did not significantly change with Welchol in any of the primary studies. The addition of Welchol to metformin- based therapy achieved a significant mean reduction in A1C levels of 0.42% while A1C increased by 0.08% in the placebo group, resulting in a placebo- corrected mean change from baseline of -0.50% (P<0.001). Fasting plasma glucose decreased by -4.6 mg/dL in the Welchol group and increased by 11.1 mg/dL in the group treated with placebo, resulting in a mean treatment difference of -15.7 mg/dL (P<0.001). Furthermore, the addition of Welchol to metformin therapy resulted in a significantly higher proportion of patients achieving a mean reduction in A1C of greater than or equal to 0.7% (38.3% vs. 19.4%; P<0.001) or a reduction in FPG greater than or equal to 30 mg/dL (30.1% vs. 22.0%; p=0.015), from baseline to endpoint versus the placebo.

A second pooled analysis evaluated 653 patients on sulfonylurea-based therapy (monotherapy or combination with other antidiabetes agents). Patients
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