Evidence map›Paper›PMID 26530268›Full record

Trial reportAdvances in therapy2015

Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus.

Nobuya Inagaki, Maki Goda, Shoko Yokota, Nobuko Maruyama, Hiroaki Iijima

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Advances in therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01387737 (An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01387737 phase3completednot on this map

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

TypeinterventionalSponsorTanabe Pharma CorporationRan2011 to 2012Enrolled1,299ConditionsType 2 Diabetes MellitusArmsTA-7284-Low, TA-7284-High
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. SGLT2 Inhibitors: New Hope for the Treatment of Acute Myocardial Infarction?American journal of cardiovascular drugs : drugs, devices, and other interventions · 2022
    Review
  7. An Overview of the Cardiorenal Protective Mechanisms of SGLT2 Inhibitors.International journal of molecular sciences · 2022
    Review
  8. Article
  9. Potential Impact on Lipoprotein Subfractions in Type 2 Diabetes.Clinical medicine insights. Endocrinology and diabetes · 2019
    Article
  10. Effects of sodium-glucose cotransporter 2 inhibitors on urinary excretion of intact and total angiotensinogen in patients with type 2 diabetes.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2017
    Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Maki GodaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan. gouda.maki@mm.mt-pharma.co.jp.
Shoko YokotaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Nobuko MaruyamaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Hiroaki IijimaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Mitsubishi Tanabe Pharma CorporationKyoto University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSodium glucose co-transporter 2 inhibitors decrease hemoglobin A1c (HbA1c) and blood pressure (BP) and slightly increase low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes mellitus (T2DM). The effects of baseline BP and LDL-C on the safety and efficacy of canagliflozin in patients were analyzed post hoc in a phase III study.

methodsJapanese patients with T2DM were classified by baseline systolic BP (SBP) of <130 or ≥130 mmHg, diastolic BP (DBP) of <80 or ≥80 mmHg, and LDL-C of <120 or ≥120 mg/dL. Canagliflozin was administered daily to patients for 52 weeks at doses of either 100 mg (n = 584) or 200 mg (n = 715). The effects of canagliflozin on the incidence of adverse events (AEs), BP, and LDL-C were evaluated.

resultsNo clear differences were observed in overall safety among the subgroups classified by baseline SBP, DBP, or LDL-C, except for a slight imbalance in AEs associated with volume depletion with 200 mg of canagliflozin. The decrease in mean SBP and DBP was evident in subgroups with baseline SBP ≥130 mmHg and DBP ≥80 mmHg. Mean LDL-C was decreased in subgroups with baseline LDL-C ≥120 mg/dL at both canagliflozin doses, and they were slightly increased, but did not exceed 120 mg/dL in subgroups with baseline LDL-C <120 mg/dL. The changes in HbA1c and body weight from those observed at baseline were not different between subgroups classified by SBP, DBP, and LDL-C at either dose.

conclusionThe present post hoc analysis indicates that canagliflozin is well tolerated irrespective of baseline BP and LDL-C in patients with T2DM.

trial registrationClinicalTrials.gov identifier, NCT01387737.

fundingMitsubishi Tanabe Pharma Corporation.

Indexed as

Blood PressureAgedAsian PeopleBody WeightCanagliflozinCholesterol, LDLDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsIncidenceJapanMaleMiddle AgedSodium-Glucose Transporter 2CanagliflozinCholesterol, LDLGlycated HemoglobinHypoglycemic AgentsSodium-Glucose Transporter 2Blood pressureCanagliflozinLow-density lipoprotein cholesterol (LDL-C)Sodium glucose co-transporter 2 (SGLT2) inhibitorType 2 diabetes mellitusVolume depletion

Identifiers

PMID26530268
PMCPMC4662712
OpenAlexW2144295528

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.