Abstract | BACKGROUND: METHODS: Pooled data from 4 randomised, placebo-controlled, 26-week, Phase 3 studies (N = 2,313) evaluating canagliflozin 100 and 300 mg were analysed by age: <65 years (n = 1,868; mean age, 52.8 years) or ≥65 years (n = 445; mean age, 69.3 years). Efficacy evaluations included change from baseline in glycaemic parameters and systolic blood pressure (BP), and percent change from baseline in body weight. Assessment of safety/tolerability included adverse event (AE) reports, incidence of documented hypoglycaemia, and percent change from baseline in fasting plasma lipids. RESULTS:
Canagliflozin 100 and 300 mg reduced HbA1c and fasting plasma glucose relative to placebo in patients <65 and ≥65 years of age. Both canagliflozin doses reduced body weight and systolic BP relative to placebo in patients <65 and ≥65 years of age. Incidence of overall AEs was similar across all treatment groups in patients <65 and ≥65 years of age. Incidences of serious AEs and AE-related discontinuations were similar across all treatment groups in patients <65 years of age and higher with canagliflozin 100 mg than other groups in patients ≥65 years of age. As in patients <65 years of age, incidences of genital mycotic infections and osmotic diuresis-related AEs were higher with canagliflozin relative to placebo in those ≥65 years of age. Incidences of urinary tract infections (UTIs), renal-related AEs, AEs related to volume depletion, and documented hypoglycaemia episodes were similar across all treatment groups in patients ≥65 years of age; no notable trends were observed with canagliflozin 100 and 300 mg relative to placebo in these AEs among patients <65 years of age. Changes in lipid parameters with canagliflozin were similar in both age subsets. CONCLUSIONS:
Canagliflozin improved glycaemic control, body weight, and systolic BP, and was generally well tolerated in older patients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01081834; NCT01106677; NCT01106625; NCT01106690.
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Authors | Alan Sinclair, Bruce Bode, Stewart Harris, Ujjwala Vijapurkar, Cristiana Mayer, Albert Fung, Wayne Shaw, Keith Usiskin, Mehul Desai, Gary Meininger |
Journal | BMC endocrine disorders
(BMC Endocr Disord)
Vol. 14
Pg. 37
(Apr 18 2014)
ISSN: 1472-6823 [Print] England |
PMID | 24742013
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Glucosides
- Thiophenes
- Canagliflozin
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Canagliflozin
- Clinical Trials, Phase III as Topic
- Diabetes Mellitus, Type 2
(drug therapy)
- Female
- Glucosides
(therapeutic use)
- Humans
- Male
- Meta-Analysis as Topic
- Middle Aged
- Prognosis
- Randomized Controlled Trials as Topic
- Thiophenes
(therapeutic use)
- Young Adult
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