Evidence map›Paper›PMID 27600862›Full record

Trial reportInternational journal of clinical practice2016

Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates.

Mathew John, Sonia Cerdas, Rafael Violante, Chaicharn Deerochanawong, Mohamed Hassanein, April Slee, William Canovatchel, Gill Hamilton

5 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00968812. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT00968812 phase3completed

A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

Ran2009Enrolled1,452Registered outcomes4Posted comparisons8ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin (JNJ-28431754), Glimepiride, Metformin
Open the trial in the graph
NCT01081834 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Ran2010Enrolled678Registered outcomes16Posted comparisons16ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin, Placebo, Sitagliptin
Open the trial in the graph
NCT01106625 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

Ran2010Enrolled469Registered outcomes7Posted comparisons14ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin, Metformin, Placebo, Sulphonylruea
Open the trial in the graph
NCT01106677 phase3completed

A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Ran2010Enrolled1,284Registered outcomes14Posted comparisons35ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin, Metformin immediate release, Placebo, Sitagliptin
Open the trial in the graph
NCT01106690 phase3completed

A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

Ran2010Enrolled344Registered outcomes8Posted comparisons16ConditionsDiabetes Mellitus, Type 2ArmsCanagliflozin, Metformin, Pioglitazone, Placebo, Sitagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  6. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Observational
  12. Review
  13. Article
  14. Article
  15. 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

8 authors at 6 institutions in 5 countries.

Mathew JohnProvidence Endocrine & Diabetes Specialty Centre, Trivandrum, Kerala, India. drmathewjohn@yahoo.com.
Sonia CerdasHospital Cima, Centro de Investigacíon Clínica San Agustín, San José, Costa Rica.
Rafael ViolanteCentro de Estudios de Investigacíon Metabólicos y Cardiovasculares S.C., Tampico, Mexico.
Chaicharn DeerochanawongRajavithi Hospital, Rangsit Medical School, Bangkok, Thailand.
Mohamed HassaneinDubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
April SleeAxio Research, Seattle, WA, USA.
William CanovatchelJanssen Global Services, LLC, Raritan, NJ, USA.
Gill HamiltonJanssen-Cilag Ltd, High Wycombe, UK.
Dubai Hospital · AEJanssen (United Kingdom) · GBJanssen (United States) · USJothydev's Diabetes and Research Center · INRangsit University · THSeattle University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsPatients with type 2 diabetes mellitus (T2DM) have increased risk of adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This analysis assessed the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot climates.

methodsThis post hoc analysis evaluated patients with T2DM using pooled data from four 26-week, placebo-controlled studies (N=2,313) and data from a 104-week, active-controlled study (add-on to metformin vs glimepiride; N=1,450). Changes in HbA1c, fasting plasma glucose (FPG), body weight and blood pressure (BP) were assessed in subsets of patients living in hot climates (pooled, placebo-controlled studies, n=611; active-controlled study, n=307) and those living in other climates (i.e. other climate subset; pooled, placebo-controlled studies, n=1,702; active-controlled study, n=1,143). Safety was assessed based on AE reports.

resultsCanagliflozin 100 and 300 mg lowered HbA1c, FPG, body weight and BP vs placebo over 26 weeks and glimepiride over 104 weeks in the hot climate subsets. Canagliflozin was generally well tolerated in the hot climate subsets, with a higher incidence of AEs related to the mechanism of SGLT2 inhibition (i.e. genital mycotic infections). Volume depletion-related AEs were low across groups.

conclusionCanagliflozin improved glycaemic control, lowered body weight and BP, and was generally well tolerated in patients with T2DM living in hot climates compared with placebo over 26 weeks or glimepiride over 104 weeks. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT01081834, NCT01106677, NCT01106625, NCT01106690, NCT00968812.

Indexed as

AdolescentAdultAgedAged, 80 and overBlood PressureCanagliflozinDiabetes ComplicationsDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGenital Diseases, FemaleGenital Diseases, MaleGlycated HemoglobinHot TemperatureHumansHypoglycemiaCanagliflozinGlycated HemoglobinHypoglycemic Agents

Identifiers

PMID27600862
PMCPMC5129493
OpenAlexW2520540059

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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 Socratic graph.