WARNING: LACTIC ACIDOSIS
Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.
Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.
If acidosis is suspected, JANUMET1 should be discontinued and the patient hospitalized immediately. [See Warnings and Precautions.]
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JANUMET SUMMARY
WARNING: LACTIC ACIDOSIS
JANUMET (sitagliptin/metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: sitagliptin and metformin hydrochloride. Sitagliptin Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in JANUMET tablets in the form of sitagliptin phosphate monohydrate.
JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [See Clinical Studies .]
Important Limitations of Use
JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
JANUMET has not been studied in combination with insulin.
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NEWS HIGHLIGHTS
Published Studies Related to Janumet (Sitagliptin / Metformin)
Tolerability and pharmacokinetics of metformin and the dipeptidyl peptidase-4 inhibitor sitagliptin when co-administered in patients with type 2 diabetes. [2006.10]
OBJECTIVE: As part of the clinical development of sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes, the potential for pharmacokinetic interactions with other antihyperglycemic agents used in managing patients with type 2 diabetes are being carefully evaluated. The purposes of this study were to evaluate the tolerability of co-administered sitagliptin and metformin and effects of sitagliptin on metformin pharmacokinetics as well as metformin on sitagliptin pharmacokinetics under steady-state conditions... CONCLUSIONS: In this study, co-administration of sitagliptin and metformin was generally well tolerated in patients with type 2 diabetes and did not meaningfully alter the steady-state pharmacokinetics of either agent.
Janumet: a combination product suitable for use in patients with Type 2 diabetes. [2008.10]
Inhibition of the enzyme dipeptidyl peptidase-4 represents the latest pharmacologic intervention to become available to assist patients with Type 2 diabetes to achieve glycemic control. A combination tablet of sitagliptin (Januvia) and metformin HCl (Glucophage) is now available from Merck (Janumet)...
Clinical Trials Related to Janumet (Sitagliptin / Metformin)
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus [Not yet recruiting]
This study will assess the effect of Janumet (MK0431A) compared with the effect of
glimepiride on HbA1c.
A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin [Not yet recruiting]
Comparison between the effectiveness of one anti-diabetic drug (Metformin, To combination of
this drug and additional drug (Janufer), In the community setting.
MK0431A Comparative Study in Patients With Type 2 Diabetes [Recruiting]
Comparative Study of MK0431A in Patients With Type 2 Diabetes [Recruiting]
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used
medication in patients with type 2 diabetes
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes [Recruiting]
A study to evaluate the efficacy and safety of Sitagliptin and MK0431A in comparison to a
commonly used medication in patients with type 2 diabetes.
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Page last updated: 2009-02-08
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