( inical Pharmacology(12.3).) Use...)An Investigational Study Released at ADA Showed that Initial,Combination Therapy with Januvia (sitagliptin) and Metformin Led to,Improvement in Markers of Beta Cell Function in Patients with Type,2 Diabetes,Health

inical Pharmacology (12.3).) Use with Medications Known to Cause Hypoglycemia: In clinical trials of JANUVIA as monotherapy and JANUVIA as part of combination therapy with metformin or pioglitazone, rates of hypoglycemia reported with JANUVIA were similar to rates in patients taking placebo. The use of JANUVIA in combination with medications known to cause hypoglycemia, such as sulfonylureas or insulin, has not been adequately studied. 6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience In controlled clinical studies as both monotherapy and combination therapy, the overall incidence of adverse reactions with JANUVIA was similar to that reported with placebo. Discontinuation of therapy due to clinical adverse reactions was also similar to placebo. Two placebo-controlled monotherapy studies, one of 18- and one of 24-week duration, included patients treated with JANUVIA 100 mg daily, JANUVIA 200 mg daily, and placebo. Two 24-week, placebo-controlled combination studies, one with metformin and one with pioglitazone, were also conducted. In addition to a stable dose of metformin or pioglitazone, patients whose diabetes was not adequately controlled were given either JANUVIA 100 mg daily or placebo. The adverse reactions, reported regardless of investigator assessment of causality in greater than or equal to 5% of patients treated with JANUVIA 100 mg daily as monotherapy or in combination with pioglitazone and more commonly than in patients treated with placebo, are shown in Table 1. Table 1 Placebo-Controlled Clinical Studies of JANUVIA Monotherapy or Combination with Pioglitazone: Adverse R
'"/>




Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
Related medicine technology :

1. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
2. Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes
3. Investigational Study Demonstrated a Re-Establishment of Clinical Improvement with Orencia (Abatacept) in Children with Juvenile Idiopathic Arthritis upon Re-Introduction of Therapy
4. Mercks Investigational Migraine Treatment MK-0974 Significantly Improved Migraine Pain on Several Efficacy Measures in a Phase II Study
5. Data Demonstrated Metastatic Melanoma Response to Investigational Immunotherapy Ipilimumab
6. Investigational Drug Cediranib (AZD2171) Shows Promise in Patients With Recurrent Glioblastoma (GBM)
7. Additional New Data from Satraplatin SPARC Phase 3 Investigational Trial Presented at ASCO Annual Meeting
8. Additional New Data from Satraplatin SPARC Phase 3 Investigational Trial Presented at ASCO Annual Meeting
9. Investigational Cancer Drug Pertuzumab Shows Promising Results in Advanced Breast Cancer When Combined with Herceptin
10. Shire Announces Positive Results of Studies With Guanfacine Extended Release, An Investigational Nonstimulant Medication Filed for the Treatment of ADHD in Children and Adolescents
11. Investigational Study Evaluates the Effectiveness of Aripiprazole in Adolescents With Schizophrenia