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New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes
Date:11/21/2008

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  • the prespecified pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia in patients treated with JANUVIA 100mg was similar to placebo (1.2% vs 0.9%). Adverse reactions of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required. The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA 100mg, 2.3%; placebo, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%).

    • an additional, 24-week, placebo-controlled factorial study of initial therapy with sitagliptin in combination with metformin, the adverse reactions reported (regardless of investigator assessment of causality) in >=5% of patients are shown in Table 2. The incidence of hypoglycemia was 0.6% in patients given placebo, 0.6% in patients given sitagliptin alone, 0.8% in patients given metformin alone, and 1.6% in patients given sitagliptin in combination with metformin.

    Table 2

    Initial Therapy with Combination of Sitagliptin and Metformin:

    Adverse Reactions Reported (Regardless of Investigator Assessment of Causality) in >=5% of PatientsReceiving Combination Therapy (and Greater than in Patients Receiving Metformin alone, Sitagliptinalone, and Placebo)†

    Number of Patients (%) Placebo

    Sitagliptin(JANUVIA)100 mg QD

    Metformin500 or 1000 mg bid ††

    Sitagliptin50 mg bid +Metformin500 or 1000 mg bid ††

    N = 176 N = 179 N = 364†† N = 372†† Upper Respiratory Infection 9 (5.1) 8 (4.5) 19 (5.2) 23 (6.2) Headache 5 (2.8) 2 (1.1) 14
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