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JANUMET® XR
(sitagliptin and metformin HCl
extended-release) tablets

JANUMET®
(sitagliptin/metformin HCI)
tablets

JANUVIA®
(sitagliptin)
tablets

JUVISYNC™
(sitagliptin and simvastatin)
tablets

Patient
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Starting Therapy

For appropriate patients with type 2 diabetes...

Start with JANUMET: Help nearly twice as many patients get to goal

In a study of patients uncontrolled with diet and exercise at 24 weeks1:

  • Starting with JANUMET got nearly twice as many patients to goal as metformin alone
  • Similar rate of GI adverse events vs metformin alone
Efficacy Formulary Savings
A1C goal attainment


Primary end point: change in A1C at 24 weeks

Powerful glucose reductions beyond metformin alone, placebo-adjusted1

  • Sitagliptin 100 mg daily; mean baseline A1C 8.9%; n=175; –0.8%
  • Metformin 1000 mg daily; mean baseline A1C 8.9%; n=178; –1.0%
  • Metformin 2000 mg daily; mean baseline A1C 8.7%; n=177; –1.3%
  • JANUMET 100/1000 mg daily; mean baseline A1C 8.8%; n=183; –1.6% (P≤0.001 vs monotherapy components)
  • JANUMET 100/2000 mg daily; mean baseline A1C 8.8%; n=178; –2.1% (P≤0.001 vs monotherapy components)

GI adverse events

  • Similar rate of gastrointestinal adverse events vs metformin alone
  • Weight loss for JANUMET similar to metformin alone at 24 weeks, range: –1.3 lb to –2.9 lb
  • Incidence of hypoglycemia for JANUMET similar to metformin alone over 24 weeks, range: 0.5% to 2.2%

When added to a sulfonylurea (glimepiride) or insulin, patients treated with sitagliptin + metformin experienced:


  • An increased incidence of hypoglycemia: 16% for patients treated with sitagliptin + metformin + glimepiride vs 1% for placebo + metformin + glimepiride and 15% for patients treated with sitagliptin + metformin + insulin vs 8% for placebo + metformin + insulin. A lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia
  • Weight gain: +0.9 lb for patients treated with sitagliptin + metformin + glimepiride vs –1.5 lb for placebo + metformin + glimepiride

View Study Design

Selected Important Risk Information
There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis.

Measure renal function before initiation of therapy with JANUMET and periodically thereafter. In patients in whom development of renal dysfunction is anticipated, particularly in elderly patients, renal function should be assessed more frequently and JANUMET discontinued if evidence of renal impairment is present.

When lactic acidosis occurs, it is fatal in approximately 50% of cases. The reported incidence of lactic acidosis in patients receiving metformin is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications.

Please read the Boxed Warning about lactic acidosis.

JANUMET: Study evaluating initial combination therapy1-3

Objective

To assess the glycemic efficacy and safety of JANUMET in patients with type 2 diabetes who had inadequate glycemic control (A1C 7.5%–11%) on diet and exercise.

Study design

A total of 1,091 patients with type 2 diabetes and inadequate glycemic control on diet and exercise participated in a randomized, double-blind, placebo-controlled factorial study designed to assess the efficacy and safety of JANUMET (coadministered as separate tablets of sitagliptin and metformin) compared to respective monotherapies. Patients were randomized into 1 of 6 treatment groups: JANUMET 50/500 mg bid, JANUMET 50/1000 mg bid, metformin 500 mg bid, metformin 1000 mg bid, sitagliptin 100 mg once daily, or placebo. After a 24-week, placebo-controlled period, patients receiving placebo were switched in a blinded manner to metformin (beginning with 500 mg/day and uptitrated weekly in 500-mg increments to 2000 mg/day); all other patients continued on the same treatment throughout a 30-week continuation phase. The primary end point was measured after 24 weeks of treatment (phase A). The study continued with a 30-week continuation (phase B), followed by a 50-week extension study.

Enrolled patient population

Patients aged 18 to 78 years who were either on, or not on, an oral antihyperglycemic agent at screening, with an A1C of 7.5%–11% after wash off.

End points

Primary: A1C change at week 24.
Secondary: Included change at week 24 in FPG, HOMA-β, HOMA-IR, and a standard meal tolerance test.

image: baseline characteristics

References 1. Goldstein BJ, Feinglos MN, Lunceford JK, et al; for Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30(8):1979–1987. Dr. Goldstein is currently an employee at Merck, but was in academia at the time of publication. 2. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(5):442–451. 3. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes: a 54-week study. Curr Med Res Opin. 2009;25(3):569–583.

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3.
Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(5):442–451.
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6.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DIAB-1003569-0001.
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9.
Goldstein BJ, Feinglos MN, Lunceford JK, et al; for Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30:1979–1987. Dr. Goldstein is currently an employee at Merck, but was in academia at the time of publication.
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10.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DIAB-1003569-0000.
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45.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 21052857(1)-JAN.
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46.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DIAB-1003569-0002.
Close
55.
Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes: a 54-week study. Curr Med Res Opin. 2009;25(3):569–583.
Close
56.
Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package DIAB-1023729-0000.
Close
57.
Reasner C, Olansky L, Seck TL, et al. 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. Diabetes Obes Metab. 2011;13(7):644–652.
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58.
Olansky L, Reasner C, Seck TL, et al. 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. Diabetes Obes Metab. 2011;13(9):841–849.