Tolerability Profile
JANUVIA in initial combination therapy with metformin
Learn about:
Hypoglycemia
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
Established tolerability profile: Similar rates of hypoglycemia with JANUVIA + metformin vs metformin alone1
Percentage of patients with ≥1 episode of hypoglycemia over 24 weeks (APaT population)
APaT = all-patients-as-treated.
Back to top | Study design below
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 adult patients with type 2 diabetes
Established tolerability profile: Similar weight change with JANUVIA + metformin vs metformin alone1
Weight loss for JANUVIA + metformin vs metformin alone
LS = least squares; APaT = all-patients-as-treated.
Back to top | Study design below
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.
GI events
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
Established tolerability profile: Similar rate of GI events with JANUVIA + metformin vs metformin alone1
Incidence of all GI adverse events for JANUVIA + metformin vs metformin alone over 24 weeksa,b

(a) Incidence of all GI adverse events: placebo (n=176), 10.8%; JANUVIA 100 mg daily (n=179), 15.1%.
(b) Percentage of patients (APaT population).
GI = gastrointestinal; APaT = all-patients-as-treated.
Back to top | Study design below
The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA and metformin was similar to those of placebo and metformin: nausea (1.3%, 0.8%), vomiting (1.1%, 0.8%), abdominal pain (2.2%, 3.8%) and diarrhea (2.4%, 2.5%).
Study design
Study evaluating the efficacy and safety of initial combination therapy with sitagliptin and metformin vs metformin or sitagliptin alone: 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 sitagliptin + metformin compared with respective monotherapies. Patients were randomized into 1 of 6 treatment groups: sitagliptin + metformin 50/500 mg bid (n=190), sitagliptin + metformin 50/1000 mg bid (n=182), metformin 500 mg bid (n=182), metformin 1000 mg bid (n=182), sitagliptin 100 mg once daily (n=179), or placebo (n=176). The primary end point was measured after 24 weeks of treatment.1
bid = twice daily.