the efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-na?ve patients with type 2 diabetes mellitus a randomized controlled trial的疗效和安全性dipeptidyl peptidase-4抑制剂saxagliptin treatment-na ve 2型糖尿病患者的随机对照试验.pdfVIP
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the efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-na?ve patients with type 2 diabetes mellitus a randomized controlled trial的疗效和安全性dipeptidyl peptidase-4抑制剂saxagliptin treatment-na ve 2型糖尿病患者的随机对照试验
Frederich et al. Diabetology Metabolic Syndrome 2012, 4:36
DIABETOLOGY
/content/4/1/36
METABOLIC SYNDROME
RESEARCH Open Access
The efficacy and safety of the dipeptidyl
peptidase-4 inhibitor saxagliptin in
treatment-naïve patients with type 2 diabetes
mellitus: a randomized controlled trial
1* 2 3 1 1
Robert Frederich , Robert McNeill , Niklas Berglind , Douglas Fleming and Roland Chen
Abstract
Background: The aim of this study was to assess efficacy and safety of saxagliptin monotherapy for up to 76 weeks
in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, with main efficacy assessment at
24 weeks.
Methods: 365 treatment-naïve patients with T2DM (HbA1c 7.0%– 10.0%) were treated with saxagliptin 2.5 mg q.A.M.,
saxagliptin 2.5 mg q.A.M. with possible titration to saxagliptin 5 mg, saxagliptin 5 mg q.A.M., saxagliptin 5 mg q.P.
M., or placebo. After week 24, patients in all groups were eligible for titration to saxagliptin 10 mg based on HbA1c
≥7%, and all unrescued placebo patients began blinded metformin 500 mg/day. Rescue with open-label metformin
was available for patients with inadequate glycemic control.
Results: At week 24, placebo-subtracted mean HbA1c reduction from baseline (LOCF) was significantly greater in
the saxagliptin treatment groups vs placebo, and remained greater through week 76. Serious adverse events (AEs)
and discontinuations due to AEs were similar in saxagliptin and control groups; incidence of confirmed
hypoglycemia was low acros
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