Trial reportBritish journal of clinical pharmacology2017
Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.
Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A model-based meta analysis study of sodium glucose co-transporter-2 inhibitors.CPT: pharmacometrics & systems pharmacology · 2023Pooled it
- Population Pharmacokinetic and Pharmacodynamic Modeling to Support Molar Dose Ratio Determination of Long-Acting Insulin Analogs.Clinical pharmacokinetics · 2026Trial
- Pharmacokinetic and pharmacodynamic modelling for renal function dependent urinary glucose excretion effect of ipragliflozin, a selective sodium-glucose cotransporter 2 inhibitor, both in healthy subjects and patients with type 2 diabetes mellitus.British journal of clinical pharmacology · 2019Trial
- Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.British journal of clinical pharmacology · 2017Trial
- Population pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus.British journal of clinical pharmacology · 2026Article
- Population Pharmacokinetic-pharmacodynamic Model Analysis of Dapagliflozin for HbA1c-lowering Effects in Japanese Patients with Type 2 Diabetes Mellitus using Long-term Real-world Data.International journal of medical sciences · 2025Article
- Comparison of Power, Prognosis, and Extrapolation Properties of Four Population Pharmacodynamic Models of HbA1c for Type 2 Diabetes.CPT: pharmacometrics & systems pharmacology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimCanagliflozin is an SGLT2 inhibitor approved for the treatment of type-2 diabetes. A dynamic population pharmacokinetic-pharmacodynamic (PK/PD) model relating 24-h canagliflozin exposure profiles to effects on glycosylated haemoglobin was developed to compare the efficacy of once-daily and twice-daily dosing.
methodsData from two clinical studies, one with once-daily, and the other with twice-daily dosing of canagliflozin as add-on to metformin were used (n = 1347). An established population PK model was used to predict full 24-h profiles from measured trough concentrations and/or baseline covariates. The dynamic PK/PD model incorporated an E
resultsInternal and external model validation demonstrated that the model adequately predicted HbA1c-lowering for canagliflozin once-daily and twice-daily dosing regimens. The differences in HbA1c reduction between the twice-daily and daily mean profiles were minimal (at most 0.023% for 100 mg total daily dose [TDD] and 0.011% for 300 mg TDD, up to week 26, increasing with time and decreasing with TDD) and not considered clinically meaningful.
conclusionsSimulations using this model demonstrated the absence of clinically meaningful between-regimen differences in efficacy, supported the regulatory approval of a canagliflozin-metformin immediate release fixed-dose combination tablet and alleviated the need for an additional clinical study.
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