The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.
The information on this site is intended for healthcare professionals in the United States and is not intended for the general public.
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.
A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis.
JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiating JANUVIA, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.
When JANUVIA was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.
There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA, such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.
In clinical studies, the adverse reactions reported, regardless of investigator assessment of causality, in >5% of patients treated with JANUVIA as monotherapy and in combination therapy and more commonly than in patients treated with placebo, were upper respiratory tract infection, nasopharyngitis, and headache.
There are no adequate and well-controlled studies in pregnant women. Therefore, JANUVIA should be used during pregnancy only if clearly needed.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., maintains a registry to monitor the pregnancy outcomes of women exposed to JANUVIA while pregnant. Health care providers are encouraged to report any prenatal exposure to JANUVIA by calling the Pregnancy Registry at 1-800-986-8999.
It is not known whether sitagliptin is excreted in human milk. Therefore, caution should be exercised when JANUVIA is administered to a nursing woman.
Safety and effectiveness of JANUVIA in children under 18 years have not been established.
No dosage adjustment is required based on age; however, because JANUVIA is substantially excreted by the kidney, it may be useful to assess renal function in elderly patients before initiation and periodically thereafter.
a Intent-to-treat population.
To enhance the precision of subgroup analyses through a prespecified pooling of data from Phase III monotherapy studies.
Both multicenter, randomized, double-blind studies evaluated the safety and efficacy of monotherapy with JANUVIA in patients with type 2 diabetes who have inadequate glycemic control and were similarly designed with placebo-controlled treatment periods of either 24 weeks or 18 weeks. The placebo group and the group receiving JANUVIA 100 mg were pooled for analysis of change from baseline in A1C by subgroup factors at the common time point of Week 18.
Men and women aged 18 to 75 with type 2 diabetes with inadequate glycemic control (A1C between 7% and 10%). Because these studies included a placebo treatment group, patients with more severe hyperglycemia (A1C >10%) were not enrolled. Patients with type 1 diabetes or a history of ketoacidosis were also excluded.
The placebo and JANUVIA groups were pooled for analysis of the difference in change from baseline in A1C by subgroup factors at the common time point of Week 18.
To assess the glycemic efficacy and safety of JANUVIA as monotherapy in patients with type 2 diabetes who had inadequate glycemic control with diet and exercise.
A multinational, randomized, parallel-group trial with a placebo-controlled, double-blind period and a single-blind treatment period. Study design included a screening diet and exercise run-in period of up to 15 weeks, a diet and exercise run-in period of up to 12 weeks, an antihyperglycemic agent (AHA) wash-off for patients on AHAs, and a 2-week, single-blind, placebo-controlled run-in period before randomization into the 18-week, double-blind, placebo-controlled treatment period.
Men and women (N=521) aged 18 to 75 with type 2 diabetes who had inadequate glycemic control with diet and exercise, defined by A1C between 7% and 10%. Because this study included a placebo treatment group, patients with more severe hyperglycemia (A1C >10%) were not enrolled. Patients with type 1 diabetes or a history of ketoacidosis were also excluded.
Primary: Effect of treatment with JANUVIA compared with placebo on A1C as well as safety and tolerability of JANUVIA.
Secondary: Included assessment of effect of JANUVIA on FPG, insulin, proinsulin, and lipids.
To assess the glycemic efficacy and tolerability of JANUVIA in patients with type 2 diabetes who had inadequate glycemic control on diet and exercise.
A multinational, randomized, parallel-group trial with a placebo-controlled, double-blind period and a single-blind treatment period. Study design included a screening diet and exercise run-in period of up to 15 weeks, a diet and exercise run-in period of up to 12 weeks, and a 2-week, single-blind, placebo-controlled run-in period before randomization into the 24-week, double-blind, placebo-controlled treatment period.
Men and women aged 18 to 75 with type 2 diabetes who had A1C between 7% and 10%. Because this study included a placebo treatment group, patients with more severe hyperglycemia (A1C >10%) were not enrolled. Patients with type 1 diabetes or a history of ketoacidosis were also excluded.
Primary: The effect of treatment with JANUVIA compared with placebo on A1C and to assess the safety and tolerability of JANUVIA.
Secondary: The effect of treatment with JANUVIA compared with placebo on fasting plasma glucose (FPG) and the plasma glucose profile with a standard meal challenge (PPG).
To evaluate the efficacy and safety of JANUVIA in combination with metformin in patients with type 2 diabetes who had inadequate glycemic control (A1C between 7% and 10%) on metformin monotherapy.
A 24-week, multinational, randomized, double-blind, parallel-group, placebo-controlled study with 701 patients, who after a screening diet and exercise run-in period, a metformin dose adjustment and stabilization period, and a 2-week, single-blind, placebo run-in period, were randomized to receive placebo or JANUVIA 100 mg once daily in addition to metformin therapy. Patients who did not meet specific glycemic goals during the studies were treated with pioglitazone rescue therapy.
Men and women aged 19 to 78 with mild to moderate hyperglycemia (mean A1C 8%). Patients with type 1 diabetes, a history of ketoacidosis, acute or rapidly progressive renal disease, or a history of renal transplant were excluded from this trial.
Primary: A1C change compared with placebo and safety and tolerability at Week 24.
Secondary: Change in FPG compared with placebo at Week 24 and in glucose, insulin, and C peptide measured immediately before and at 60 and 120 minutes after a meal.
To evaluate the efficacy and safety of JANUVIA in combination with pioglitazone in patients with type 2 diabetes and inadequate glycemic control (A1C between 7% and 10%) on pioglitazone therapy.
A 24-week, multinational, randomized, double-blind, parallel-group, placebo-controlled study with 353 patients who, after a screening diet and exercise run-in period, a pioglitazone dose adjustment and stabilization period, and a 2-week single-blind placebo run-in period, were randomized to receive JANUVIA 100 mg once daily in addition to pioglitazone therapy. Patients who did not meet specific glycemic goals during the studies were treated with metformin rescue therapy.
Patients with type 2 diabetes aged 18 or older inadequately controlled (A1C between 7% and 10%) with a stable dose of pioglitazone. Patients with type 1 diabetes or a history of ketoacidosis were excluded from this trial.
Primary: A1C change compared to placebo and safety and tolerability at Week 24.
Secondary: Change in FPG compared to placebo, insulin, and proinsulin.
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