Efficacy Profile
JANUVIA in initial combination therapy with metformin
Learn about:
- A1C (primary end point)
- FPG (secondary end point)
- PPG (secondary end point)
- A1C goal attainment (secondary end point)
- Study design
A1C (primary end point)
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
JANUVIA + metformin: Strong A1C lowering vs metformin alone1
Primary end point: Placebo-adjusted change from baseline A1C at week 24a

Week 24 results for patients uncontrolled on diet and exercise (intent-to-treat population).
(a) Results are adjusted for a 0.2% mean A1C increase for placebo.
(b) P<0.001 for combination therapy vs respective monotherapies.
LS = least squares.
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FPG (secondary end point)
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
JANUVIA + metformin: Strong FPG reductions vs metformin alone1
Secondary end point: Placebo-adjusted mean reductions in FPG at week 24 (P<0.001)c,d

Week 24 results for patients uncontrolled on diet and exercise (intent-to-treat population).
(c) Results are adjusted for a 6-mg/dL mean FPG increase for placebo.
(d) Includes least squares means adjusted for prior antihyperglycemic therapy and baseline values.
FPG = fasting plasma glucose.
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PPG (secondary end point)
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
JANUVIA + metformin: Strong PPG reductions vs metformin alone1
Secondary end point: Placebo-adjusted mean reductions in 2-hour PPG at week 24 (P<0.001)e,f

Week 24 results for patients uncontrolled on diet and exercise (intent-to-treat population).
(e) Includes least squares means adjusted for prior antihyperglycemic therapy and baseline values.
(f) Results are adjusted for a 0-mg/dL mean PPG reduction for placebo.
PPG = postprandial glucose.
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A1C goal attainment (secondary end point)
As an adjunct to diet and exercise for appropriate adult patients with type 2 diabetes
JANUVIA + metformin: Strong A1C lowering with about 2 of 3 patients having achieved A1C <7%1
Secondary end point: A1C goal <7% vs metformin alone at week 24

Week 24 results for patients uncontrolled on diet and exercise (intent-to-treat population).
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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.