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Treatment Goals in Type 2 Diabetes

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Treatment Goals in Type 2 Diabetes

The treatment of type 2 diabetes represents a significant challenge, as treatment goals become more aggressive and many patients may not easily reach their goals. According to an American Diabetes Association (ADA) consensus statement, "addition of medications is the rule, not the exception, if treatment goals are to be met over time."1

A1C goals in type 2 diabetes

According ADA guidelines, A1C goals should be <7% for patients in general, and for individual patients it should be <6% (as close to normal as possible).2

It has been estimated that 63% of patients with type 2 diabetes are not at the A1C goal of <7%.3

Not at A1C goal of <7%:3

LDL-C goals in type 2 diabetes

Patients with type 2 diabetes may require intensive LDL-C reduction therapy due to increased cardiovascular risk.4, 5 These patients have a cardiovascular disease risk equivalent to a post-MI patient.4

According to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Guidelines, LDL-C goals should be <100 mg/dL for patients with type 2 diabetes, with an optional goal of <70 mg/dl for patients with type 2 diabetes plus cardiovascular disease.4, 6

It has been estimated that 45% of patients with type 2 diabetes are not at the LDL-C goal of <100 mg/dL.7

Not at LDL-C goal of <100 mg/dL:7

Next: Goals in primary hyperlipidemia

References

1. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care. 2006;29:1963-72.

2. American Diabetes Association. Standards of medical care in diabetes-2007. Diabetes Care. 2007;30(suppl 1):S4-S41.

3. Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.

4. National Heart, Lung, and Blood Institute. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Final Report. Bethesda, MD: National Institutes of Health, US Dept of Health and Human Services; 2002. NIH Publication 02-5215.

5. National Diabetes Education Program. The link between diabetes and cardiovascular disease. Available at: http://ndep.nih.gov/diabetes/pubs/CVD_FactSheet.pdf. Accessed October 30, 2007.

6. Grundy SM, Cleeman JI, Bairey Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-39. Adapted with permission. Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm

7. Davidson MH, Maki KC, Pearson TA, et al. Results of the National Cholesterol Education (NCEP) Program Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE) II survey and implications for treatment under the recent NCEP Writing Group recommendations. Am J Cardiol. 2005;96:556-63.

Effective Therapy

For patients with type 2 diabetes, adding Welchol can provide additional A1C reductions.

See A1C Data

IMPORTANT INFORMATION ABOUT WELCHOL

INDICATIONS

Welchol is indicated as an adjunct to diet and exercise to:

  • Reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor
  • Improve glycemic control in adults with type 2 diabetes mellitus

Important Limitations of Use

  • Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Welchol has not been studied in type 2 diabetes as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with thiazolidinediones
  • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias

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.

WARNINGS AND PRECAUTIONS

Welchol can increase serum TG concentrations particularly when used in combination with sulfonylureas or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL. Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat soluble vitamin deficiencies. Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders. Welchol reduces gastrointestinal absorption of some drugs. Drugs with a known interaction with colesevelam (glyburide, levothyroxine, and oral contraceptives [ethinyl estradiol, norethindrone]) should be administered at least 4 hours prior to Welchol. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug.

ADVERSE REACTIONS

Primary Hyperlipidemia: In clinical trials, the adverse reactions observed in placebo – regardless of investigator assessment of causality were constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs. 3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%), pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% vs. 3.1%), rhinitis (3.2% vs. 3.1%) and myalgia (2.1% vs. 0.4%). Type 2 Diabetes: In clinical trials, the adverse reactions observed in placebo – regardless of investigator assessment of causality were constipation (8.7% vs. 2.0%), nasopharyngitis (4.1% vs. 3.6%), dyspepsia (3.9% vs. 1.4%), hypoglycemia (3.0% vs. 2.3%), nausea (3.0% vs. 1.4%) and hypertension (2.8% vs. 1.6%). Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship. Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol. Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol.

PREGNANCY

Welchol is Pregnancy Category B.

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This information is intended for U.S. healthcare professionals only.
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