JANUVIA SUMMARY
JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.
JANUVIA1 is indicated for the following:
Monotherapy and Combination Therapy
JANUVIA1 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [See Clinical Studies.]
Important Limitations of Use
JANUVIA 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.
JANUVIA has not been studied in combination with insulin.
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NEWS HIGHLIGHTS
Published Studies Related to Januvia (Sitagliptin)
A thorough QTc study to assess the effect of sitagliptin, a DPP4 inhibitor, on ventricular repolarization in healthy subjects. [2009.08]
A randomized, double-blind, placebo-controlled, 4-period crossover study was performed with a single oral dose of sitagliptin (100 mg, 800 mg), moxifloxacin (400 mg), and placebo in order to provide a rigorous assessment of the effect of sitagliptin on ventricular repolarization based on the ICH E14 guidance...
Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. [2009.03]
The aim of the study was to assess the efficacy/safety of once- (100 mg q.d.) or twice-daily (50 mg b.i.d.) sitagliptin 100 mg/day in Japanese patients with type 2 diabetes (T2DM). In this randomized, double-blind study, 80 patients with inadequate glycemic control (HbA1c=6.5-10%; FPG </=15.0 mmol/l) were randomized equally to sitagliptin 100 mg q.d., 50 mg b.i.d...
Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. [2009.01]
The efficacy and safety of sitagliptin as monotherapy were evaluated in Chinese, Indian, and Korean patients with type 2 diabetes inadequately controlled by diet and exercise. In a randomized, placebo-controlled, double-blind, 18-week trial, 530 patients with HbA(1c) >or=7.5% and <or=11.0% (mean baseline 8.7%) received sitagliptin 100mg once daily or placebo...
Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. [2008.02]
CONCLUSIONS: Addition of sitagliptin 100 mg once daily to ongoing metformin therapy was well-tolerated and resulted in significant glycemic improvement in patients with moderately severe T2DM who were treated for 30 weeks.
Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. [2008.02]
Efficacy and tolerability of sitagliptin, a dipeptidyl peptidase-4 inhibitor, were assessed in Japanese patients with type 2 diabetes. In a multicenter, double-blind, randomized, placebo-controlled trial in Japan, 151 patients with inadequate glycemic control [HbA(1c) > or =6.5% to <10%, fasting plasma glucose (FPG) > or =126 to < or =240 mg/dL] were randomized to once-daily sitagliptin 100mg or placebo for 12 weeks...
Clinical Trials Related to Januvia (Sitagliptin)
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.
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2) [Recruiting]
This study will compare the benefits of exenatide once weekly treatment to those achieved by
the approved antidiabetic therapies sitagliptin and thiazolidinedione in subjects whose type
2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three
treatment regimens will also be compared.
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects [Recruiting]
Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in
combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus.
Sitagliptin has been shown to have fewer side effects in the control of blood glucose
values.
Obesity and diabetes are states of increased inflammation and can influence the free
radicals and inflammatory markers (chemicals in the blood which increase due to inflammation
in the body) and are also major risk factors for atherosclerotic disease. In this study we
want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may
exert an anti-inflammatory effect in the human. The purpose of this study is to determine if
the addition of sitagliptin to diabetic patients will provide added benefit. We believe that
sitagliptin provides these added benefits by suppressing free radicals (charged substances
that cause damage to the body) and inflammation.
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus [Recruiting]
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone
co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients
with type 2 diabetes
Effect of Sitagliptin on Incretin Effect in Patients With Type 2 Diabetes Mellitus [Recruiting]
The purpose of this study is to assess the effect of the DPP-4 inhibitor sitagliptin on the
incretin effect in patients with type 2 diabetes mellitus.
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