Abstract | INTRODUCTION: METHODS: Subjects (N = 716) aged 55 to 80 years (mean, 63.6 years) with glycated hemoglobin (HbA1c) levels ≥ 7.0% to ≤ 10.0% were randomized. Seven hundred fourteen received canagliflozin 100 mg or 300 mg or placebo (1:1:1) daily. The prespecified primary endpoint was change from baseline in HbA1c level at week 26. Prespecified secondary endpoints included proportion of subjects achieving HbA1c levels < 7.0%, change from baseline in fasting plasma glucose (FPG) level and systolic blood pressure (BP), and percent change from baseline in body weight, triglyceride levels, and high-density lipoprotein cholesterol (HDL-C) level. Adverse events (AEs) were reported throughout the study. RESULTS: At week 26, treatment with canagliflozin 100 mg and 300 mg significantly reduced HbA1c levels compared with placebo (-0.60%, -0.73%, -0.03%, respectively; P < 0.001); more subjects achieved HbA1c levels < 7.0% with both canagliflozin doses compared with placebo (P < 0.001). Both canagliflozin doses significantly reduced body weight, FPG level, and systolic BP, and increased HDL-C level compared with placebo (P < 0.001); low-density lipoprotein cholesterol level was increased with both canagliflozin doses compared with placebo. The overall AE incidence was slightly higher with canagliflozin 300 mg than with canagliflozin 100 mg or placebo (78.0%, 72.2%, 73.4%, respectively). Serious AE and AE-related discontinuation rates were low across groups. Both canagliflozin doses were associated with higher rates than placebo of genital mycotic infections, urinary tract infections, and osmotic diuresis-related AEs (ie, pollakiuria, polyuria). Documented hypoglycemia rates were modestly higher with both canagliflozin doses compared with placebo. CONCLUSION:
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Authors | Bruce Bode, Kaj Stenlöf, Daniel Sullivan, Albert Fung, Keith Usiskin |
Journal | Hospital practice (1995)
(Hosp Pract (1995))
Vol. 41
Issue 2
Pg. 72-84
(Apr 2013)
ISSN: 2154-8331 [Print] England |
PMID | 23680739
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glucosides
- Hypoglycemic Agents
- Sodium-Glucose Transporter 2 Inhibitors
- Thiophenes
- Canagliflozin
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Topics |
- Age Factors
- Aged
- Aged, 80 and over
- Canagliflozin
- Diabetes Mellitus, Type 2
(drug therapy)
- Double-Blind Method
- Female
- Glucosides
(adverse effects, pharmacology, therapeutic use)
- Humans
- Hypoglycemic Agents
(adverse effects, pharmacology, therapeutic use)
- Male
- Middle Aged
- Prospective Studies
- Safety
- Sodium-Glucose Transporter 2 Inhibitors
- Thiophenes
(adverse effects, pharmacology, therapeutic use)
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