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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

ride with or without metformin, were also conducted. In addition to a stable dose of metformin, pioglitazone, glimepiride, or glimepiride and metformin, patients whose diabetes was not adequately controlled were given either JANUVIA 100mg daily or placebo. The adverse reactions, reported regardless of investigator assessment of causality in >=5% of patients treated with JANUVIA 100mg daily as monotherapy, JANUVIA in combination with pioglitazone, or JANUVIA in combination with glimepiride, with or without metformin, and more commonly than in patients treated with placebo, are shown in Table1.
Table 1

Placebo-Controlled Clinical Studies of JANUVIA Monotherapy or Add-on Combination Therapy with Pioglitazone or Glimepiride +/- Metformin: Adverse Reactions Reported in >=5% of Patients and More Commonly than in Patients Given Placebo, Regardless of Investigator Assessment of Causality†

Number of Patients (%) Monotherapy JANUVIA 100 mg Placebo N = 443 N = 363 Nasopharyngitis 23 (5.2) 12 (3.3) Combination with Pioglitazone JANUVIA 100 mg + Pioglitazone

Placebo + Pioglitazone

N = 175 N = 178 Upper Respiratory Tract Infection 11 (6.3) 6 (3.4) Headache 9 (5.1) 7 (3.9) Combination with Glimepiride (+/- Metformin) JANUVIA 100 mg + Glimepiride

(+/- Metformin)

Placebo + Glimepiride

(+/- Metformin)

N = 222 N = 219 Hypoglycemia 27 (12.2) 4 (1.8) Nasopharyngitis 14 (6.3) 10 (4.6) Headache 13 (5.9) 5 (2.3) † Intent to treat population

  • the study of patients receiving JANUVIA as add-on combination therapy with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in e5% of patients and more commonly than in patients given placebo.


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