Product Indications
The following agents are indicated for the treatment of type 2 diabetes, when used as directed by a clinician. NDEI.org visitors 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.
NEW: Now featuring information on Risk Evaulation and Mitgation Strategy (REMS) and patient Medication Guides.
Precose® (acarbose) is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose levels in patients with type 2 diabetes whose hyperglycemia cannot becontrolled by diet and exercise alone. Acarbose may also be used in combination with a sulfonylurea when diet and exercise plus either acarbose or a sulfonylurea does not result in adequate glycemic control. In addition, acarbose may be used in combination with insulin or metformin.
Glyset® (miglitol) is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone. Miglitol may also be used in combination with a sulfonylurea when diet and exercise plus either miglitol or a sulfonylurea alone does not result in adequate glycemic control.
JANUMET XR® (sitagliptin and metformin hydrochloride extended-release) is a combination dipeptidyl peptidase-IV (DPP-IV) inhibitor and biguanide product indicated as an adjunct to diet and exercise to improve glycemic control among adults with type 2 diabetes in whom treatment with both sitagliptin and metformin extended-release is appropriate. JANUMET XR should not be used to treat type 1 diabetes or diabetic ketoacidosis. Use of JANUMET XR has not been studied in patients with a history of pancreatitis.
WARNINGS
- Lactic acidosis can occur due to metformin accumulation. Risk is increased among those with renal impairment, sepsis, dehydration, excess alcohol intake, hepatic insufficiency, and acute congestive heart failure. JANUMET XR should be discontinued and the patient should be hospitalized immediately if acidosis is suspected
- JANUMET XR is contraindicated in patients with renal dysfunction, metabolic acidosis (including diabetic ketoacidosis), and hypersensitivity to sitagliptin or metformin extended-release
Click here for Janumet XR patient Medication Guide.
Janumet™ (sitagliptin/metformin HCl) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin.
Update 4/4/11:
Janumet has been released from the REMS requirement by FDA. Click here for the Janumet patient Medication Guide.
Update 9/25/09:
FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.
Eighty-eight (88) postmarketing cases of acute pancreatitis, including two (2) cases of hemorrhagic or necrotizing pancreatitis, in patients using sitagliptin were reported to the agency between October 16, 2006 and February 9, 2009. Based on these reports, FDA is working with the manufacturer of sitagliptin/metformin to revise the prescribing information to include:
- Information regarding postmarketing reports of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis
- Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected during use of these products
- Information noting that sitagliptin has not been studied in patients with a history of pancreatitis
Click here for additional information.
Linagliptin and metformin hydrochloride (Jentadueto™) is a combination dipeptidyl peptidase-IV (DPP-IV) inhibitor and biguanide product indicated as an adjunct to diet and exercise to improve glycemic control among adults with type 2 diabetes in whom treatment with both linagliptin and metformin is appropriate. Jentadueto should not be used to treat type 1 diabetes or diabetic ketoacidosis. Use of Jentadueto with insulin has not been studied.
WARNINGS
- Lactic acidosis can occur due to metformin accumulation. Risk is increased among those with renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. Jentadueto should be discontinued and the patient should be hospitalized immediately if acidosis is suspected
- Jentadueto is contraindicated in patients with renal impairment, metabolic acidosis (including diabetic ketoacidosis), and hypersensitivity to linagliptin or metformin
Metformin (Glucophage®, Riomet®, Fortamet®, Glumetza®) is indicated as monotherapy as an adjunct to diet and exercise to lower blood glucose levels in patients with hyperglycemia cannot be controlled by diet and exercise alone. Metformin may be used in combination with a sulfonylurea or insulin to improve glycemic control.
JANUMET XR® (sitagliptin and metformin hydrochloride extended-release) is a combination dipeptidyl peptidase-IV (DPP-IV) inhibitor and biguanide product indicated as an adjunct to diet and exercise to improve glycemic control among adults with type 2 diabetes in whom treatment with both sitagliptin and metformin extended-release is appropriate. JANUMET XR should not be used to treat type 1 diabetes or diabetic ketoacidosis. Use of JANUMET XR has not been studied in patients with a history of pancreatitis.
WARNINGS
- Lactic acidosis can occur due to metformin accumulation. Risk is increased among those with renal impairment, sepsis, dehydration, excess alcohol intake, hepatic insufficiency, and acute congestive heart failure. JANUMET XR should be discontinued and the patient should be hospitalized immediately if acidosis is suspected
- JANUMET XR is contraindicated in patients with renal dysfunction, metabolic acidosis (including diabetic ketoacidosis), and hypersensitivity to sitagliptin or metformin extended-release
Click here for Janumet XR patient Medication Guide.
Linagliptin and metformin hydrochloride (Jentadueto™) is a combination dipeptidyl peptidase-IV (DPP-IV) inhibitor and biguanide product indicated as an adjunct to diet and exercise to improve glycemic control among adults with type 2 diabetes in whom treatment with both linagliptin and metformin is appropriate. Jentadueto should not be used to treat type 1 diabetes or diabetic ketoacidosis. Use of Jentadueto with insulin has not been studied.
WARNINGS
- Lactic acidosis can occur due to metformin accumulation. Risk is increased among those with renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. Jentadueto should be discontinued and the patient should be hospitalized immediately if acidosis is suspected
- Jentadueto is contraindicated in patients with renal impairment, metabolic acidosis (including diabetic ketoacidosis), and hypersensitivity to linagliptin or metformin
Januvia™ (sitagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Sitagliptin is also indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin or a PPAR-gamma agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Update 4/4/11:
Januvia has been released from the REMS requirement by FDA. Click here for the Januvia patient Medication Guide.
Janumet™ (sitagliptin/metformin HCl) is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. Update 4/4/11: Janumet has been released from the REMS requirement by FDA. Click here for the Janumet patient Medication Guide.
Update 9/25/09:
FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.
Eighty-eight (88) postmarketing cases of acute pancreatitis, including two (2) cases of hemorrhagic or necrotizing pancreatitis, in patients using sitagliptin were reported to the agency between October 16, 2006 and February 9, 2009. Based on these reports, FDA is working with the manufacturer of sitagliptin/metformin to revise the prescribing information to include:
- Information regarding postmarketing reports of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis
- Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected during use of these products
- Information noting that sitagliptin has not been studied in patients with a history of pancreatitis
Click here for additional information.
JUVISYNC™ (sitagliptin and simvastatin tablets) is indicated in patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to reduce the risk of total mortality by reducing coronary heart disease deaths; reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), Apo B, and triglycerides, and increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated triglycerides in patients with hypertriglyceridemia and reduce triglycerides and very—low-density lipoprotein cholesterol (VLDL-C) in patients with primary dysbetalipoproteinemia; and reduce total cholesterol and LDL-C in adult patients with homozygous familial hypercholesterolemia.
Onglyza™ (saxagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. Onglyza should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
WARNING
When used with an insulin secretagogue (eg, sulfonylurea), a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia.
Tradjenta™ (linagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This agent should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis and has not been studied in combination with insulin.
WARNING
When used with an insulin secretagogue (eg, sulfonylurea), a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia. No clinical studies establishing conclusive evidence of macrovascular risk reduction with this or any other antidiabetic drug have been conducted.
WARNING
- Exenatide extended-release causes thyroid C-cell tumors at clinically relevant exposures in rats. It is unknown whether Bydureon causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies.
- Bydureon is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Click here for Bydureon Risk Evaluation and Mitigation Strategy (REMS).
Click here for Bydureon patient Medication Guide.
WARNING
- Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in rodents. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be determined by clinical or nonclinical studies.
- Victoza is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Click here for Victoza Risk Evaluation and Mitigation Strategy (REMS).
Click here for Victoza patient Medication Guide.
Update 10/19/11:
FDA has approved a new use for Byetta, which is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.
Update 8/5/11:
Byetta has been released from the REMS requirement by FDA. Click here for the Byetta patient Management Guide.
Update 11/2/09:
FDA has approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.
Changes include:
- Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease
- Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
- Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product
Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta Click here for additional information.
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 hyperglycemia cannot be controlled by diet and exercise alone.
The various forms of insulin can be used in combination with various oral antidiabetic agents to regulate blood glucose levels.
Prandin® (repaglinide) is indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone. Repaglinide is also indicated for use in combination with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either repaglinide or metformin alone.
Starlix® (nateglinide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Starlix is contraindicated in patients with type 1 diabetes and diabetic ketoacidosis.
First-Generation Agents
Diabinese® (chlorpropamide). Indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone. Chlorpropamide may be used in combination with insulin when sulfonylurea monotherapy fails to reduce symptoms and/or blood glucose levels.
Second-Generation Agents
Glucotrol® (glipizide); DiaBeta, Glynase, or Micronase (glyburide); or Amaryl (glimepiride). Indicated as an adjunct to diet and exercise to lower blood glucose levels in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone. Glipizide, glyburide, or glimepiride may be used in combination with insulin when sulfonylurea monotherapy fails to reduce symptoms and/or blood glucose levels.
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 type 2 diabetes (non-insulin-dependent diabetes mellitus, NIDDM). Pioglitazone hydrochloride is indicated for monotherapy. Pioglitazone hydrochloride is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent does not result in adequate glycemic control.
Update 6/15/11:
FDA has informed the public that use of the diabetes medication, Actos (pioglitazone), for more than 1 year may be associated with an increased risk of bladder cancer. Information about the risk will be added to the Warninings and Precautions section of the label for pioglitazone-containing medications. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer
Click here for additional information.
Click here for Actos patient Medication Guide.
Actoplus Met™ and Actoplus Met™ XR (pioglitazone hydrochloride and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control.
Click here for Actoplus Met patient Medication Guide.
Click here for Actoplus Met XR patient Medication Guide.
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 type 2 diabetes who are already treated with a combination of pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control.
Click here for Duetact patient Medication Guide.
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 type 2 diabetes mellitus. Rosiglitazone maleate is indicated as monotherapy. Rosiglitazone maleate is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and a single agent do not result in adequate glycemic control. For patients inadequately controlled with a maximum dose of a sulfonylurea or metformin, rosiglitazone maleate should be added to, rather than substituted for, a sulfonylurea or metformin. Rosiglitazone maleate is also indicated for use in combination with a sulfonylurea plus metformin when diet, exercise, and both agents do not result in adequate glycemic control.
Update 5/18/11:
FDA announced new restrictions to the prescribing and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl). Healthcare providers and patients must enroll in a special program to prescribe and receive these drugs.
FDA has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
Click here for additional information.
Click here for the Avandia-Rosiglitazone Medicines Access Program.
Update 2/3/11:
Avandia labels now contain updated information about cardiovascular risks and use in certain patients.
The FDA announced that information on the cardiovascular risks (including heart attack) of the diabetes drug, rosiglitazone, has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2011 as part of new restrictions for prescribing and use of this drug.
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other antidiabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Click here for the Avandia patient Medication Guide.
Click here for Advandamet patient Medication Guide.
Click here for Avandaryl patient Medication Guide.
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