Tolerability Profile
JANUVIA head-to-head vs sulfonylurea
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Hypoglycemia
As an adjunct to diet and exercise for appropriate patients with type 2 diabetes:
Established tolerability profile: Lower incidence of hypoglycemia with JANUVIA + metformin compared with glipizide + metformin1
Percentage of patients (APaT population) reporting 1 or more episodes of hypoglycemia over 52 weeks

Week 52 results for patients uncontrolled on ≥1500 mg metformin.
(a) P<0.001 for between-group difference.
APaT = all-patients-as-treated.
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When added to a sulfonylurea (glimepiride) or insulin, patients treated with JANUVIA experienced increased incidence of hypoglycemia.
12.2% for patients treated with JANUVIA + glimepiride ± metformin vs 1.8% for placebo + glimepiride ± metformin; 15.5% for patients treated with JANUVIA + 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
As an adjunct to diet and exercise for appropriate patients with type 2 diabetes:
Established tolerability profile: No weight gain with JANUVIA + metformin vs glipizide + metformin1,2
LS mean change in weight from baseline (APaT population) at week 52b

Week 52 results for patients uncontrolled on ≥1500 mg metformin.
(b) Values at 52 weeks: 389 for metformin + JANUVIA and 416 for metformin + glipizide.
(c) For between-treatment-group comparison at 52 weeks.
LS = least squares; APaT = all-patients-as-treated.
This is an electronic version of a figure published in Diabetes, Obesity and Metabolism. Volume 9, Issue 2, pages 194-205, March 2007. Author: Nauck. Published by Wiley.
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When added to a sulfonylurea (glimepiride) or insulin, patients treated with JANUVIA experienced a mean increase in body weight.
+1.8 lb for patients treated with JANUVIA + glimepiride ± metformin vs –0.9 lb for placebo + glimepiride ± metformin; +0.2 lb for patients treated with JANUVIA + insulin ± metformin vs +0.2 lb for placebo + insulin ± metformin.
Study design
52-week study evaluating sitagliptin vs glipizide in patients uncontrolled on metformin alone: A multinational, randomized, double-blind, parallel-group, noninferiority study was conducted in 1,172 patients with type 2 diabetes who were 18 to 78 years of age and were inadequately controlled on metformin (A1C ≥6.5%–≤10%). Patients on a stable dose of metformin (≥1500 mg/day) were randomized to receive sitagliptin 100 mg once daily (n=588) or glipizide 5 mg/day (n=584) in addition to metformin. Based on glycemic control, glipizide could be titrated to a maximum dose of 20 mg/day. The efficacy and safety of sitagliptin were compared with glipizide over 52 weeks.1