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Clinical Guideline
Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline From the American College of Physicians
Amir Qaseem, MD, PhD, MHA; Linda L. Humphrey, MD, MPH; Donna E. Sweet, MD; Melissa Starkey, PhD; and Paul Shekelle, MD, PhD, for the Clinical Guidelines Committee of the American College of Physicians*

Description: The American College ofPhysicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the comparative effectiveness and safety of type 2 diabetes medications. Methods: This guideline is based on a systematic evidence review evaluating literature published on this topic from 1966 through April 2010 that was identified by using MEDLINE (updated through December 2010), EMBASE, and theCochrane Central Register of Controlled Trials. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy. This guideline grades the evidence and recommendations by using the American College of Physicians clinicalpractice guidelines grading system. Recommendation 1: ACP recommends that clinicians add oral pharmacologic therapy in patients diagnosed with type 2 diabetes

when lifestyle modifications, including diet, exercise, and weight loss, have failed to adequately improve hyperglycemia (Grade: strong recommendation; high-quality evidence). Recommendation 2: ACP recommends that clinicians prescribemonotherapy with metformin for initial pharmacologic therapy to treat most patients with type 2 diabetes (Grade: strong recommendation; high-quality evidence). Recommendation 3: ACP recommends that clinicians add a second agent to metformin to treat patients with persistent hyperglycemia when lifestyle modifications and monotherapy with metformin fail to control hyperglycemia (Grade: strongrecommendation; highquality evidence).

Ann Intern Med. 2012;156:218-231. For author affiliations, see end of text.

www.annals.org

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iabetes mellitus is the seventh leading cause of death in the United States. In addition, it is a leading cause of morbidity and leads to microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular (coronary artery, cerebrovascular, and peripheralvascular disease) complications. Type 2 diabetes mellitus is the most common form of the disease (affecting 90% to 95% of persons with diabetes), with a prevalence of approximately 25.8 million people in the United States (1). Type 2 diabetes increases with age, and nearly 27% of people in the United States older than 65 years have diabetes (1). In addition, because of increasing rates of obesity inthe United States, the incidence and prevalence of diabetes mellitus are increasing substantially (1). The costs associated
See also: Print Summary for Patients. . . . . . . . . . . . . . . . . . . . . . . I-36 Web-Only Appendix Tables Conversion of graphics into slides

with diabetes in the United States alone reached $174 billion in 2007 (2). Good management of type 2 diabetes withpharmacologic and nonpharmacologic therapies is important and includes patient education, evaluation for microvascular and macrovascular complications, treatment of glycemia, and minimization of cardiovascular and other long-term risks. In the United States, 11 unique classes of drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperglycemia in type 2 diabetes; all ofthese medications vary in cost and risk (3). Among people diagnosed with diabetes, most will receive more than 1 class of diabetes medication: 14% take both insulin and oral medication and 58% take oral medications only (2). The purpose of this American College of Physicians (ACP) guideline is to address the pharmacologic management of type 2 diabetes by comparing the effectiveness and safety of...