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Head-to-Head vs Sulfonylurea

For appropriate patients uncontrolled on metformin...

Add the power of JANUVIA


In a 24-week study of patients inadequately controlled on metformin...

Adding JANUVIA to metformin provided significant A1C reductions vs metformin alone1

A1C reductions at 24 weeks in APT (all patients treated) population

type 2 diabetes add-on therapy

  • Similar incidence of gastrointestinal adverse events with JANUVIA plus metformin vs
    metformin alone
  • A significant number of patients who were uncontrolled on metformin achieved A1C goal <7% by adding JANUVIA (47% vs 18% for placebo + metformin)


In a separate study of JANUVIA (100 mg daily) added to ongoing metformin therapy ( >1500 mg daily). . .

Adding JANUVIA to metformin provided powerful reductions in A1C2

type 2 diabetes add-on therapy
  • In this study, patients taking JANUVIA had a similar incidence of hypoglycemia compared with patients taking placebo (1.0% vs 0.0%)
  • JANUVIA also demonstrated a neutral effect on body weight (decrease in mean body weight of 1.1 lb with both placebo and JANUVIA)

When added to certain other therapies such as glimepiride or insulin, patients treated with sitagliptin experienced an increased incidence of:

  • Hypoglycemia: 12.2% for patients treated with sitagliptin + glimepiride ± metformin vs 1.8% for placebo + glimepiride ± metformin; 15.5% for patients treated with sitagliptin + insulin ± metformin vs 7.8% for placebo + insulin ± metformin. A lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia
  • Weight gain: +1.8 lb for patients treated with sitagliptin + glimepiride ± metformin vs –0.9 lb for placebo + glimepiride ± metformin; +0.2 lb for patients treated with sitagliptin + insulin ± metformin vs +0.2 lb for placebo + insulin ± metformin

Selected Important Risk Information

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.

Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dose of JANUVIA is prescribed.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. A subset of these reports involved patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA 100 mg vs placebo was as follows: abdominal pain (2.3%, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%).

View Additional Selected Important Risk Information

JANUVIA: 24-week study in patients inadequately controlled on metformin1

Objective

To assess the efficacy and safety of JANUVIA, added to ongoing metformin therapy, in patients with type 2 diabetes with inadequate glycemic control (A1C ≥7% and ≤10%) with metformin alone.

Study design

A randomized, double-blind, placebo-controlled parallel group study to evaluate the safety and efficacy of JANUVIA as add-on therapy to patients with type 2 diabetes and inadequate control with metformin. A total of 701 patients were randomized 1:2 to receive the addition of placebo or JANUVIA 100 mg once-daily, for 24 weeks. The efficacy analyses were based on the all-patients-treated population.

Enrolled patient population

Men and women (aged 18–78 years) with type 2 diabetes and inadequate glycemic control (A1C ≥7% and ≤10%) while taking metformin monotherapy at a stable dose of at least 1,500 mg/day, either at entry into the study or after a metformin dose-stable run-in period, were eligible to be randomized.

End points

Primary: A1C change at week 24
Secondary: Change at week 24 in FPG, and in glucose, insulin, and C-peptide concentrations during a standard meal.

Januvia® (sitagliptin) : efficacy and safety as add-on to metformin study

Reference: 1. Charbonnel B, Wu M, Karasik A, et al; for Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29(12):2638–2643.

JANUVIA: An evaluation of efficacy and safety when added to metformin1

Objective

To evaluate the efficacy and safety of JANUVIA as an add-on to metformin therapy in patients with moderately severe (A1C ≥8.0%–≤11.0%) type 2 diabetes mellitus.

Study design

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of adding JANUVIA in 190 patients with type 2 diabetes inadequately controlled on metformin (A1C ≥8.0%–≤11.0%). Primary analysis was the A1C reduction after 18 weeks of treatment.

Enrolled patient population

Patients aged 18 to 78 years who were: (1) currently on metformin monotherapy or any other single oral antihyperglycemic agent, or (2) treated with metformin in combination with another oral antihyperglycemic agent.

End points

Primary: A1C change at week 18
Secondary: Change from baseline in FPG and 2-hour PPG at week 18, and change from baseline in A1C at week 30.

Januvia® (sitagliptin) : efficacy and safety as add-on to metformin study

Reference: 1. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537–550.

 
Important Information

JANUVIA® (sitagliptin) tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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.

Before prescribing JANUVIA® (sitagliptin) tablets, please read the Prescribing Information. The Medication Guide also is available.

References: 1. Charbonnel B, Wu M, Karasik A, et al; for Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29(12):2638–2643. 2. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537–550.

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Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of  Merck & Co., Inc. All rights reserved.

DIAB-1050515-0002 12/12

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2.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DIAB-1003569-0004.
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16.
Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537–550.
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Herman GA, Stevens C, Van Dyck K, et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005;78(6):675-688.
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Alba M, Sheng D, Guan Y, et al. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009;25(10):2507-2514.
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Charbonnel B, Wu M, Karasik A, et al. Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone. Diabetes Care, 2006; 29:2638–2643.
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JANUVIA: Single-dose study design1 :

Objective

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of JANUVIA.

Study design

Two double-blind, randomized, placebo-controlled studies were conducted at a single study center. In each study, 6 subjects received single oral doses of JANUVIA (1.5–600 mg) and 2–3 subjects received placebo in a randomized, balanced manner.

Enrolled patient population

Healthy male volunteers with normal glucose concentrations.

End points

Pharmacokinetic assessments: Plasma concentrations of JANUVIA.
Pharmacodynamic assessments: DPP-4 enzyme activity, active and total GLP-1 assays, and glucose, insulin, glucagon, and C-peptide assays.

DPP-4 = dipeptidyl peptidase-4.
GLP-1 = glucagon-like peptide 1.

Reference: 1. Herman GA, Stevens C, Van Dyck K, et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005;78(6):675-688.