For appropriate patients uncontrolled on metformin...
Similar A1C reductions and goal achievement with significantly less hypoglycemia and with weight loss, compared with glipizide
Compared with glipizide in a 52-week add-on study of patients uncontrolled on >1500 mg metformin,
JANUVIA delivered1 :
- Similar A1C reductions and goal attainment
- Weight loss and significantly less hypoglycemia
Comparable A1C reductions at 52 weeks (primary end point)
- In the intent-to-treat population, patients treated with JANUVIA + metformin (n=576) achieved LS mean A1C reductions from baseline comparable to glipizide ≥ 5–20 mg (mean daily dose 10 mg): JANUVIA –0.5% (mean baseline A1C 7.7%); glipizide –0.6% (mean baseline A1C 7.6%)
- In the per-protocol analysis, from a mean baseline A1C of 7.5%, similar LS mean A1C reductions were seen: JANUVIA –0.7% (n=382); glipizide –0.7% (n=411).1 Note: The per-protocol population included patients without major protocol violations who had observations at baseline and week 52
- A conclusion in favor of the noninferiority of JANUVIA to glipizide may be limited to patients with baseline A1C comparable to those included in the study (>70% of patients had baseline A1C <8%, and >90% had A1C <9%)
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
aPer-protocol population; bPercentage of patients (all-patients-as-treated population); P<0.001 for between-group difference; cLeast squares mean change from baseline in body weight, lb (all-patients-as-treated population; dn values shown at 52 weeks; dNauck MA et al. Diabetes Obes Metab. 2007:9(2);194–205. ©2007 Blackwell Publishing Ltd. Reproduced with permission of Blackwell Publishing, Ltd.; eFor between-treatment-group comparison at 52 weeks.
View Percentage of Hypoglycemic Events
Selected Important Risk Information
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.
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.
JANUVIA: 52-week study results vs glipizide in patients uncontrolled on metformin alone1,2
Objective
To assess the effect of the addition of JANUVIA compared with glipizide on A1C in patients with type 2 diabetes with inadequate glycemic control (A1C >6.5 – <10.0%) on metformin >1500 mg/day.
Study design
In a multinational, double-blind, randomized, factorial, parallel-group study, with week 52 as the primary time point, patients meeting eligibility criteria were randomized to receive JANUVIA 100 mg/day or glipizide 5 mg/day (which could be titrated up to 20 mg/day), in a 1:1 ratio.
Enrolled patient population
Patients aged 18 to 78 years (1) not on an antihyperglycemic agent, (2) on a single antihyperglycemic agent (either metformin or another agent), or (3) on dual oral combination treatment with metformin and another antihyperglycemic agent.
End points
Primary: A1C change at week 52.
Secondary: Including change in FPG, incidence of hypoglycemic events, body weight, C-peptide, insulin, and glucose profiles after a meal challenge.
References: 1. Nauck MA, Meininger G, Sheng D, et al; for Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9(2):194–205. 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-1038791-0003.
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. Nauck MA, Meininger G, Sheng D, et al; for Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9(2):194–205. 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-1045468-0001.
Copyright © 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
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