Janumet Vs. Metformin: Drug Comparison

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).

Metformin is an oral medication commonly prescribed to manage blood sugar levels in individuals with type 2 diabetes. It works by decreasing glucose production in the liver, improving the body's sensitivity to insulin, and reducing the amount of sugar absorbed by the intestines. Metformin is often used as a first-line treatment due to its efficacy, safety profile, and additional benefits, such as weight stabilization and low risk of low blood sugar. Common side effects include gastrointestinal issues like nausea, diarrhea, and abdominal discomfort.

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

Metformin hydrochloride: biguanide

Biguinide

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

Metformin hydrochloride tablets are indicated:

• As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus

• Typically taken orally twice daily

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

• Typically taken orally once, twice, or three times daily

• Comes in 500 mg, 850 mg, and 1,000 mg tablets

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

For metformin hydrochloride, the most common adverse reactions (>5%) are:

• Diarrhea

• Nausea/vomiting

• Flatulence

• Weakness

• Indigestion

• Abdominal discomfort

• Headache

• 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

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

• Hypersensitivity to metformin

• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

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

• 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

• Lactic acidosis: See Boxed Warning

• Vitamin B12 deficiency: Metformin may lower vitamin B12 levels

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

• Females and males of reproductive potential: 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.

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 metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

*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.

*This information is from the metformin hydrochloride label used by Epic Pharma, LLC. See the Full Prescribing Information for more complete information. Metformin may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient metformin.