Welchol (colesevelam hydrochloride)

Company
Daiichi Sankyo

Approval Status
Approved January 2008

Treatment for
glycemic control in type 2 diabetes mellitus

Areas
Diabetes / Endocrinology

Welchol contains colesevelam hydrochloride, a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent. It works by binding bile acids, including the major bile acid in humans known as glycocholic acid. However, the exact mechanism by which Welchol improves glycemic control is unknown.

Welchol is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Welchol is supplied as a 625 mg tablet designed for oral administration. The recommended initial dose of the drug is 6 tablets once daily or 3 tablets twice daily. Welchol should be taken with a meal and liquid.

FDA Approval
The FDA approval of Welchol for this indication was based on the results of three clinical trials. These double-blind, placebo-controlled add-on therapy trials enrolled a total of 1,018 subjects with baseline A1C 7.5-9.5%. The subjects received Welchol, in combination with metformin, sulfonylureas or insulin or placebo administered either as 3 tablets twice daily with lunch and dinner or as 6 tablets with dinner alone.

Add-on Combination Therapy with Metformin:
Welchol 3.8 g/day or placebo was added to background anti-diabetic therapy in a 26-week trial of 316 subjects already receiving treatment with metformin alone (N=159) or metformin in combination with other oral agents (N=157). The combination of Welchol plus metformin resulted in statistically significant placebo-corrected reductions in A1C with a -0.6 treatment difference (p<0.001) and FPG with a -14 treatment difference (p=0.10). The mean percent change in serum LDL-C levels with Welchol compared to placebo was -16% among statin users and statin non-users; the median percent change in serum TG levels with Welchol compared to placebo was -2% among statin users and 10% among statin non-users. The mean change in body weight was -0.5 kg for Welchol and -0.3 kg for placebo.

Add-on Combination Therapy with Sulfonylurea:
Welchol 3.8 g/day or placebo was added to background anti-diabetic therapy in a 26-week trial of 460 patients already treated with sulfonylurea alone (N=156) or sulfonylurea in combination with other oral agents (N=304). In combination with a sulfonylurea, Welchol resulted in statistically significant placebo corrected reductions in A1C and FPG. Welchol also reduced TC, LDL-C, Apo B, and non-HDL-C, but increased serum TG (Table 11). The mean percent change in serum LDLC levels with Welchol compared to placebo was -18% among statin users and -15% among statin non-users; the median percent increase in serum TG with Welchol compared to placebo was 29% among statin users and 9% among statin non-users. The mean change in body weight was 0.0 kg for Welchol and -0.4 kg for placebo.

Add-on Combination Therapy with Insulin:
Welchol 3.8 g/day or placebo was added to background anti-diabetic therapy in a 16-week trial of 287 patients already treated with insulin alone (N=116) or insulin in combination with oral agents (N=171). At baseline, the median daily insulin dose was 70 units in the Welchol group and 65 units in the placebo group. In combination with insulin, Welchol resulted in a statistically significant placebo-corrected reduction in A1C (Table 12). Welchol also reduced LDL-C and Apo B, but increased serum TG (Table 13). The mean percent change in serum LDL-C levels with Welchol compared to placebo was -13% among statin users and statin non-users; the median percent increase in serum TG levels with Welchol compared to placebo was 24% among statin users and 17% among statin non-users. The mean change in body weight was 0.6 kg for Welchol and 0.2 kg for placebo.

Ongoing Study Commitments

  • Daiichi Sankyp has agreed to study WelChol as monotherapy treatment for type 2 diabetes mellitus:
    Protocol Submission: by July 31, 2008
    Study Start: by January 31, 2009
    Final Report Submission: by July 31, 2011
  • Daiichi Sankyo has agreed to study WelChol in combination with thiazolidinediones as treatment for type 2 diabetes mellitus:
    Protocol Submission: by October 31, 2008
    Study Start: by April 30, 2009
    Final Report Submission: by October 31, 2011
  • Daiichi Sankyo has agreed to the following time lines for in Vivo Studies for an ARB, glimepiride, glipizide ER, and phenytoin:
    Protocol Submission: by June 30, 2008
    Study Start: by September 30, 2008
    Final Report Submission: by September 30, 2009

Adverse events associated with the use of Welchol may include, but are not limited to, the following:

  • Constipation
  • Nasopharyngitis
  • Dyspepsia
  • Hypoglycemia
  • Nausea
  • Hypertension

Colesevelam hydrochloride, the active pharmaceutical ingredient in Welchol, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption. However, the exact mechanism by which Welchol improves glycemic control is unknown.

For additional information regarding Welchol or glycemic control, please visit the Welchol web page.

Welchol (colesevelam hydrochloride) Drug Information

The Welchol (colesevelam hydrochloride) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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