- --------
Difference from placebo (adjusted -20ss. -17ss.
mean++) (95% CI) (-31, (-24,
-9) -10)
------------------------------------------- -------- -------- --------
2-hour PPG (mg/dL) % % N = 201 N = 204
------------------------------------------- -------- -------- --------
Baseline (mean) 257 271
------------------------------------------- -------- -------- --------
Change from baseline (adjusted
mean++) -49 -2
------------------------------------------- -------- -------- --------
Difference from placebo (adjusted -47ss.
mean++) (95% CI) (-59,
-34)
------------------------------------------- -------- -------- --------
+ Intent to Treat Population using last observation on study prior
to metformin rescue therapy.
++ Least squares means adjusted for prior antihyperglycemic
therapy status and baseline value.
ss. pless than0.001 compared to placebo.
% Data not available.
Additional Monotherapy Study
A multinational, randomized, double-blind, placebo-controlled
study was also conducted to assess the safety and tolerability of
JANUVIA in 91 patients with type 2 diabetes and chronic renal
insufficiency (creatinine clearance less than 50 mL/min). Patients
with moderate renal insufficiency received 50 mg daily of JANUVIA and
those with severe renal insufficiency or with ESRD on hemodialysis or
peritoneal dialysis received 25 mg daily. In this study, the safety
and tolerability of JANUVIA were generally similar to placebo. A small
increase in serum creatinine was reported in patients with moderate
renal insufficiency treated with JANUVIA relative to those on placebo.
In addit
'"/>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 Haemostasis2.
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 Diabetes3.
Investigational Study Demonstrated a Re-Establishment of Clinical
Improvement with Orencia (Abatacept) in Children with Juvenile
Idiopathic Arthritis upon Re-Introduction of Therapy4.
Mercks Investigational Migraine Treatment MK-0974 Significantly
Improved Migraine Pain on Several Efficacy Measures in a Phase II
Study5.
Data Demonstrated Metastatic Melanoma Response to Investigational
Immunotherapy Ipilimumab6.
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 Meeting8.
Additional New Data from Satraplatin SPARC Phase 3 Investigational
Trial Presented at ASCO Annual Meeting9.
Investigational Cancer Drug Pertuzumab Shows Promising Results in
Advanced Breast Cancer When Combined with Herceptin10.
Shire Announces Positive Results of Studies With Guanfacine
Extended Release, An Investigational Nonstimulant Medication Filed
for the Treatment of ADHD in Children and Adolescents11.
Investigational Study Evaluates the Effectiveness of Aripiprazole
in Adolescents With Schizophrenia