Januvia Vs. Metformin Sitagliptin: Drug Comparison

Januvia^® (sitagliptin) is an oral medication used to manage type 2 diabetes by inhibiting the enzyme DPP-4, which increases the levels of incretin hormones that stimulate insulin release and reduce sugar production in the liver. Its FDA-approved indication is for improving blood sugar control in adults with type 2 diabetes, typically in combination with diet and exercise. Januvia is available in tablet form and is usually taken once daily. Common side effects include upper respiratory infections, headaches, and nausea, while more serious risks include pancreatitis and kidney dysfunction. Caution is advised in patients with kidney impairment or a history of pancreatitis.

Sitagliptin and metformin together are the active ingredients in the brand-name medication Janumet^®. The information below is about brand name Janumet. According to the FDA, “Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.”

Janumet (sitagliptin and metformin) is an oral medication used to treat type 2 diabetes, combining two active ingredients: sitagliptin, a DPP-4 inhibitor, and metformin, a biguanide. It works by improving blood sugar control through sitagliptin’s ability to increase insulin production and decrease glucose production in response to meals, while metformin reduces the liver's production of glucose and improves insulin sensitivity. Its FDA-approved indication is for the management of type 2 diabetes when diet and exercise alone are insufficient to control blood sugar. Janumet comes in tablet form, taken once or twice daily with meals. Common side effects include nausea, diarrhea, and upper respiratory infections, while serious risks include lactic acidosis (from metformin) and pancreatitis (from sitagliptin).

Dipeptidyl peptidase-4 (DPP-4) inhibitor

Sitagliptin: dipeptidyl peptidase-4 (DPP-4) inhibitor

Metformin hydrochloride: biguanide

Januvia (sitagliptin) is indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Janumet (sitagliptin and metformin hydrochloride) is indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• Typically taken orally once daily

• Comes in 25 mg, 50 mg, and 100 mg tablets

• Typically taken orally twice daily

• Comes in 50 mg/500 mg and 50 mg/1,000 mg tablets

Adverse reactions reported in ≥5% of patients treated with Januvia and more commonly than in patients treated with placebo are:

• Upper respiratory tract infection

• Inflammation of the nose and throat

• Headache

In the add-on to sulfonylurea and add-on to insulin studies, low blood sugar was also more commonly reported in patients treated with Januvia compared to placebo

The most common adverse reactions reported in ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were:

• Diarrhea

• Upper respiratory tract infection

• Headache

• History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema

• Severe renal impairment: (eGFR below 30 mL/min/1.73 m² )

• Metabolic acidosis, including diabetic ketoacidosis

• History of a serious hypersensitivity reaction to Janumet, sitagliptin, or metformin, such as anaphylaxis or angioedema

• Drug interactions: carbonic anhydrase inhibitors, drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine), alcohol

• Pancreatitis

• Heart failure

• Acute renal failure

• Low blood sugar with concomitant use with insulin or insulin secretagogues

• Hypersensitivity reactions

• Severe and disabling joint pain

• Bullous pemphigoid

• Lactic acidosis

• Pancreatitis

• Heart failure

• Acute renal failure

• Vitamin B12 deficiency

• Low blood sugar with concomitant use with insulin or insulin secretagogues

• Hypersensitivity reactions

• Severe and disabling joint pain

• Bullous pemphigoid

• Females and males of reproductive potential: Advise premenopausal females of the potential for an unintended pregnancy

WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL.

Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the Full Prescribing Information.

If lactic acidosis is suspected, discontinue Janumet and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

*This information is from the label for brand name Januvia^®. See the Full Prescribing Information for more complete information. Sitagliptin, the active ingredient in Januvia, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient sitagliptin.

*This information is from the label for brand name Janumet^®. See the Full Prescribing Information for more complete information. Sitagliptin and metformin, the active ingredients in Janumet, may also be the active ingredients in other medications, and this information may not be accurate for all medications that include the active ingredients sitagliptin and metformin.