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
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)
A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. [2011.09]
AIMS: Combination therapy with sitagliptin and metformin has shown superior efficacy compared with metformin monotherapy. In this study, we compare two strategies: initial combination therapy with sitagliptin/metformin as a fixed-dose combination (FDC) and initial metformin monotherapy, with the option to add additional antihyperglycaemic agents (AHAs) in either treatment arm during the second phase of the study in order to reach adequate glycaemic control... CONCLUSIONS: A strategy initially implementing combination therapy with sitagliptin/metformin FDC was superior to a strategy initially implementing metformin monotherapy, even when accounting for the later addition of supplemental AHAs. Sitagliptin/metformin FDC was generally well tolerated. (c) 2011 Blackwell Publishing Ltd.
The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. [2011.07]
AIMS: This study was conducted to compare the glycaemic efficacy and safety of initial combination therapy with the fixed-dose combination of sitagliptin and metformin versus metformin monotherapy in drug-naive patients with type 2 diabetes... CONCLUSION: Compared with metformin monotherapy, initial treatment with sitagliptin/metformin FDC provided superior glycaemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhoea. (c) 2011 Blackwell Publishing Ltd.
A treatment strategy implementing combination therapy with sitagliptin and
metformin results in superior glycaemic control versus metformin monotherapy due
to a low rate of addition of antihyperglycaemic agents. [2011]
the second phase of the study in order to reach adequate glycaemic control... CONCLUSIONS: A strategy initially implementing combination therapy with
Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. [2010]
BACKGROUND: Treatment with an oral antihyperglycaemic agent administered as monotherapy is often unsuccessful at achieving or maintaining glycaemic control in patients with type 2 diabetes mellitus. The combined use of sitagliptin and metformin is an effective treatment for type 2 diabetes mellitus, consistent with the complementary mechanisms of action by which these two agents improve glucose control. OBJECTIVES: To establish bioequivalence between sitagliptin/metformin fixed-dose combination (FDC) tablets (Janumet(R)) and co-administration of corresponding doses of sitagliptin and metformin as individual tablets... CONCLUSION: The sitagliptin/metformin 50 mg/500 mg and 50 mg/1000 mg FDC tablets are bioequivalent to co-administration of corresponding doses of sitagliptin and metformin as individual tablets and support bioequivalence to the sitagliptin/metformin 50 mg/850 mg tablet strength. These results indicate that the safety and efficacy profile of co-administration of sitagliptin and metformin can be extended to the sitagliptin/metformin FDC tablets.
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.
Clinical Trials Related to Janumet (Sitagliptin / Metformin)
Janumet Re-examination Study (0431A-182) [Recruiting]
This survey is conducted for preparing application materials for re-examination under the
Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the
clinical usefulness of Janumet through collecting the safety information according to the
Re-examination Regulation for New Drugs.
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.
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus (MK-0431A-202 AM2) [Recruiting]
This study will assess the effect of MK-0431A compared with the effect of glimepiride on
hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, MK-0431A provides
superior reduction in HbA1c (mean change from baseline) compared to glimepiride.
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
Reports of Suspected Janumet (Sitagliptin / Metformin) Side Effects
Pancreatitis (26),
Diarrhoea (24),
Weight Decreased (21),
Lactic Acidosis (20),
Pancreatic Carcinoma (19),
Nausea (18),
Renal Failure (18),
Inappropriate Schedule of Drug Administration (16),
Malaise (15),
Lipase Increased (15), more >>
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Page last updated: 2013-02-10
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