Evidence map›Paper›PMID 28950419›Full record

ReviewDiabetes, obesity & metabolism2018

Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials.

Serge Jabbour, Jochen Seufert, Andre Scheen, Clifford J Bailey, Cathrina Karup, Anna M Langkilde

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05565976 (Dapagliflozin Effect in Cognitive Impairment in Stroke Trial), which is not on this map. Cited by 65 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 5 pooled it
15.2field-weighted citation impact, top 1% 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.

NCT05565976 phase2 / phase3unknown statusstarted 2020, after this paper: background citation

Dapagliflozin Effect in Cognitive Impairment in Stroke Trial

Ran2020Enrolled270Registered outcomes3Posted comparisons0ConditionsDementia, Vascular, Metabolic Syndrome, Mild Cognitive Impairment, Stroke, IschemicArmsAntidiabetic, Dapagliflozin 10mg Tab, Platelet Antiaggregant, Statins (Cardiovascular Agents)
Open the trial in the graph
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 158 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Hypoglycemia and associated cardiovascular diseases, morbidity and mortality in patients with type 2 diabetes mellitus in university teaching hospitals in Rwanda.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025
    Article
  20. Review

5 more citing papers are in PubMed but not listed here.

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

6 authors at 5 institutions in 5 countries.

Serge JabbourDepartment of Endocrinology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.ORCID 0000-0002-4080-0470
Jochen SeufertDivision of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg, Medical Faculty, University of Freiburg, Freiburg, Germany.
Andre ScheenDepartment of Medicine, University of Liège, Liège, Belgium.ORCID 0000-0001-9743-4371
Clifford J BaileySchool of Life and Health Sciences, Aston University, Birmingham, UK.
Cathrina KarupDepartment of AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA), AstraZeneca Gothenburg, Mölndal, Sweden.
Anna M LangkildeDepartment of R&D, AstraZeneca Gothenburg, Mölndal, Sweden.
AstraZeneca (Sweden) · SEAston University · GBThomas Jefferson University · USUniversity of Freiburg · DEUniversity of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the safety and tolerability of dapagliflozin, a highly selective sodium-glucose co-transporter-2 inhibitor, in patients with type 2 diabetes mellitus (T2DM).

methodsData were pooled from 13 placebo-controlled trials of up to 24 weeks' duration (dapagliflozin, n = 2360; placebo, n = 2295). Larger placebo-/comparator-controlled pools of 21 (≤208 weeks; dapagliflozin, n = 5936; control, n = 3403) and 30 trials (≥12 weeks; dapagliflozin, n = 9195; control, n = 4629) assessed the rare adverse events (AEs) of diabetic ketoacidosis (DKA) and lower limb amputation, respectively.

resultsOver 24 weeks, the overall incidence of AEs and serious AEs (SAEs) was similar for dapagliflozin and placebo: 60.0% vs 55.7% and 5.1% vs 5.4%, respectively. Rates of hypoglycaemia, volume depletion AEs, urinary tract infections (UTIs) and fractures were balanced between the groups. Genital infections were more frequent with dapagliflozin (5.5%) vs placebo (0.6%) and renal function AEs occurred in 3.2% vs 1.8% of patients (the most common renal AE was decreased creatinine clearance: 1.1% vs 0.7%). In the 21-study pool, 1 SAE of DKA and 3 AEs of ketonuria/metabolic acidosis occurred with dapagliflozin vs none with control; estimated combined incidence for these events was 0.03% (95% confidence interval 0.010-0.089). In the 30-study pool, lower limb amputation occurred in 8 (0.1%) and 7 (0.2%) patients receiving dapagliflozin and control, respectively.

conclusionThe overall incidence rates of AEs and SAEs were similar in the dapagliflozin and placebo/control groups, including the incidence of hypoglycaemia, volume depletion, fractures, UTIs, amputations and DKA. Genital infections were more frequent with dapagliflozin than placebo.

Indexed as

AdultAgedAmputation, SurgicalBenzhydryl CompoundsBlood VolumeClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Diabetic KetoacidosisDouble-Blind MethodFemaleFractures, SpontaneousGlomerular Filtration RateGlucosidesHumansHypoglycemiaBenzhydryl CompoundsdapagliflozinGlucosidesHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitorsantidiabetic drugdapagliflozinSGLT2 inhibitortype 2 diabetes

Identifiers

PMID28950419
PMCPMC5836959
OpenAlexW2756910166

What OpenQuestion holds

Textmetadata
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.