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The following agents are indicated for the treatment of type 2 diabetes, when used as directed by a clinician. NDEI members are advised that decisions regarding drug therapy are the responsibility of the clinician. These descriptions are provided for informational purposes only. The entire monograph for an agent should be reviewed for a thorough understanding of the drug's indications, actions, uses, and side effects.
a-Glucosidase Inhibitors
Precose® (acarbose) is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose levels in patients with whose cannot be controlled by diet and exercise alone. may also be used in combination with a when diet and exercise plus either or a does not result in adequate glycemic control. In addition, may be used in combination with or metformin.
Glyset® (miglitol) is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose in patients with whose cannot be controlled by diet and exercise alone. may also be used in combination with a when diet and exercise plus either or a alone does not result in adequate glycemic control.
Biguanides
Metformin is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose levels in patients with whose cannot be controlled by diet and exercise alone. may be used in combination with a or to improve glycemic control.
DPP-IV Inhibitors
Januvia™ (sitagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with mellitus. is also indicated in patients with type 2 to improve glycemic control in combination with or a PPAR-gamma agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Janumet™ (sitagliptin/metformin HCl) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 who are not adequately controlled on or alone or in patients already being treated with the combination of and metformin.
GLP-1 Analogues
Victoza® (liraglutide) is indicated as a once-daily injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Additionally, Victoza is not a substitute for and should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis.
Byetta® (exenatide) is indicated as adjunctive therapy to improve glycemic control in patients with type 2 who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of and a sulfonylurea, or a combination of and a thiazolidinedione, but have not achieved adequate glycemic control.
Insulin
Insulin, in its various forms (lispro [human]; human NPH; human regular; human regular and human NPH mixture; human [zinc suspension]; NPH; regular; and zinc suspension), is indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with type 1 or 2 diabetes whose cannot be controlled by diet and exercise alone.
The various forms of can be used in combination with various oral antidiabetic agents to regulate blood glucose levels.
Meglitinides
Prandin® (repaglinide) is indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with whose cannot be controlled by diet and exercise alone. is also indicated for use in combination with to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either or alone.
Sulfonylureas
First-Generation Agents
Orinase® (tolbutamide), Tolinase® (tolazamide), or Diabinese® (chlorpropamide). Indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with whose cannot be controlled by diet and exercise alone. Tolbutamide, tolazamide, or chlorpropamide may be used in combination with when monotherapy fails to reduce symptoms and/or blood glucose levels.
Second-Generation Agents
Glucotrol® (glipizide, glyburide, or glimepiride). Indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with whose cannot be controlled by diet and exercise alone. Glipizide, glyburide, or may be used in combination with when monotherapy fails to reduce symptoms and/or blood glucose levels.
Thiazolidinediones
Pioglitazone
WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including Actos® (pioglitazone), cause or exacerbate congestive heart failure in some patients. After initiation of Actos, Actosplus Met™, or Duetact™ and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of Actos®, Actosplus Met™, or Duetact™ must be considered.
- Actos®, Actosplus Met™, and Duetact™ are not recommended in patients with symptomatic heart failure. Initiation of Actos®, Actosplus Met™, or Duetact™ in patients with established NYHA Class III or IV heart failure is contraindicated.
Actos® (pioglitazone hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with (non-insulin-dependent diabetes mellitus, NIDDM). hydrochloride is indicated for monotherapy. hydrochloride is also indicated for use in combination with a sulfonylurea, metformin, or when diet and exercise plus the single agent does not result in adequate glycemic control.
Actoplus Met™ (pioglitazone hydrochloride and hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with who are already treated with a combination of and or whose diabetes is not adequately controlled with alone, or for those patients who have initially responded to alone and require additional glycemic control.
Duetact™ (pioglitazone hydrochloride and glimepiride) is indicated as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with who are already treated with a combination of and a or whose diabetes is not adequately controlled with a alone, or for those patients who have initially responded to alone and require additional glycemic control.
Rosiglitazone
WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including Avandia® (rosiglitazone), cause or exacerbate congestive heart failure in some patients. After initiation of Avandia®, Avandamet®, or Avandaryl™, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia®, Avandamet®, or Avandaryl™, must be considered.
- Avandia®, Avandamet®, and Avandaryl™, are not recommended in patients with symptomatic heart failure. Initiation of Avandia®, Avandamet®, or Avandaryl™, in patients with established NYHA Class III or IV heart failure is contraindicated.
Avandia® (rosiglitazone maleate) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with mellitus. maleate is indicated as monotherapy. maleate is also indicated for use in combination with a sulfonylurea, metformin, or when diet, exercise, and a single agent do not result in adequate glycemic control. For patients inadequately controlled with a maximum dose of a or metformin, maleate should be added to, rather than substituted for, a or metformin. maleate is also indicated for use in combination with a plus when diet, exercise, and both agents do not result in adequate glycemic control.
Update 2/22/10: FDA is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with Avandia. The clinical study, called Evaluated for Cardiovascular Outcomes and Regulation of in Diabetes (RECORD), evaluated the cardiovascular safety of among patiehts with type 2 diabetes. For more information, click here.
Avandamet® (rosiglitazone maleate and hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 when treatment with dual and therapy is appropriate.
Avandaryl™ (rosiglitazone maleate and glimepiride) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with who are already treated with a combination of and or who are not adequately controlled on a alone or for those patients who have initially responded to alone and require additional glycemic control.
Troglitazone
Rezulin® (troglitazone) was the first in the thiazolidinediones class to be launched (March 1997), was taken off the market in March 2000.
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