Evidence mapPaperPMID 30222367Full record

Trial reportDiabetes technology & therapeutics2018

Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

Robert R Henry, Poul Strange, Rong Zhou, Jeremy Pettus, Leon Shi, Sergey B Zhuplatov, Traci Mansfield, David Klein, Arie Katz

Open access · hybridFull text readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes technology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 6 pooled it
5.7field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 6 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
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  19. Association of Time in Range with Endothelial Injury in Patients with Type 2 Diabetes Treated with Exenatide.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
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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

9 authors at 4 institutions in 2 countries.

Robert R Henry1 Division of Endocrinology and Metabolism, University of California San Diego School of Medicine , San Diego, California.
Poul Strange3 Integrated Medical Development, LLC , Princeton Junction, New Jersey.
Rong Zhou4 Medpace, Inc. , Cincinnati, Ohio.
Jeremy Pettus1 Division of Endocrinology and Metabolism, University of California San Diego School of Medicine , San Diego, California.
Leon Shi3 Integrated Medical Development, LLC , Princeton Junction, New Jersey.
Sergey B Zhuplatov5 AstraZeneca , Fort Washington, Pennsylvania.
Traci Mansfield5 AstraZeneca , Fort Washington, Pennsylvania.
David Klein4 Medpace, Inc. , Cincinnati, Ohio.
Arie Katz5 AstraZeneca , Fort Washington, Pennsylvania.
AstraZeneca (Brazil) · BRIntegrated Oncology (United States) · USMedpace (United States) · USUniversity of San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlycated hemoglobin (HbA1c) and measures of short-term glycemia do not fully capture daily patterns in plasma glucose dynamics. This study evaluated 24-h glycemic profiles in patients with type 2 diabetes (T2D) initiated on dapagliflozin treatment using continuous glucose monitoring (CGM).

methodsThis randomized double-blind placebo-controlled multicenter parallel-design 4-week study compared dapagliflozin (10 mg/d; n = 50) with placebo (n = 50) in adult patients with T2D uncontrolled (HbA1c 7.5%-10.5%) on either stable doses of metformin monotherapy (≥1500 mg/d) or insulin (≥30 U/d with or without up to two oral antidiabetes drugs). CGM was used to measure 24-h glycemic profiles for 7 days pretreatment and during week 4 of treatment. The primary outcome was change from baseline in 24-h mean glucose (MG) at week 4.

resultsThe 24-h MG decreased 18.2 mg/dL with dapagliflozin and increased 5.8 mg/dL with placebo (P < 0.001). The proportion of time spent in the target glucose range (70-180 mg/dL) increased significantly with dapagliflozin versus placebo (69.6% vs. 52.9%; P < 0.001), with a small (0.3%) increase in time spent in the hypoglycemic range (<70 mg/dL), driven by those on background insulin therapy. Dapagliflozin reduced postprandial glucose and significantly decreased overall glucose variability. Few events of symptomatic hypoglycemia occurred. The most common adverse event was urinary tract infection (6% in each treatment arm).

conclusionsCompared with placebo, dapagliflozin improved measures of glycemic control and variability as assessed by CGM. Glycemic improvements were more pronounced in the group on background metformin than those receiving basal insulin.

Indexed as

AdolescentAdultAgedBenzhydryl CompoundsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsInsulinMaleBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinMetforminContinuous glucose monitoringDaily glycemic variabilityDapagliflozinSGLT2 inhibitor

Identifiers

PMID30222367
PMCPMC6208164
OpenAlexW2889577950

What Socratic holds

Textfull text, public
LicenceCC BY
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Registered trials

None linked

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.