Evidence map›Paper›PMID 25381876›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2015

Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial.

C J Bailey, E C Morales Villegas, V Woo, W Tang, A Ptaszynska, J F List

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00528372. Cited by 70 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 26 pooled it
–field-weighted citation impact
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.

NCT00528372 phase3completed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Ran2007Enrolled1,067Registered outcomes17Posted comparisons54ConditionsType 2 DiabetesArmsdapagliflozin, Dapagliflozin placebo, Metformin
PMID 20566676other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 26 syntheses or guidelines pooled it.

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  18. Metformin monotherapy for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2020 · on this map
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10 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.

C J BaileyLife and Health Sciences, Aston University, Birmingham, UK.
E C Morales Villegas
V Woo
W Tang
A Ptaszynska
J F List

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess initial pharmacotherapy of Type 2 diabetes with the sodium-glucose cotransporter-2 inhibitor dapagliflozin.

methodsThis double-blind, placebo-controlled trial, randomly allocated people with Type 2 diabetes aged 18-77 years and inadequate glycaemic control on diet and exercise [HbA1c 53-86 mmol/mol (7.0-10.0%)] to receive placebo (n = 75) or dapagliflozin monotherapy 2.5 mg (n = 65), 5 mg (n = 64) or 10 mg (n = 70) once daily in the morning. After 24 weeks, low-dose double-blind metformin 500 mg/day was added to the placebo group regimen (placebo+low-dose metformin group). Changes in HbA1c level, fasting plasma glucose and body weight, as well as adverse events, were assessed over 102 weeks.

resultsOf the 274 participants randomized, 167 completed the study (60.9%). At 102 weeks, significant differences vs placebo+low-dose metformin with dapagliflozin 5 and 10 mg were observed for HbA1c (-5.8 mmol/mol [-0.53%], P = 0.018; and -4.8 mmol/mol [-0.44%], P = 0.048), respectively); and for FPG (-0.69 mmol/L, P = 0.044; and -1.12 mmol/l, P = 0.001, respectively). For body weight, the difference between the dapagliflozin 10-mg group and the placebo+low-dose metformin group was significant (-2.60 kg; P = 0.016). Hypoglycaemic events were uncommon, with rates of 5.3% for placebo+low-dose metformin group and 0-4.6% for the dapagliflozin groups. Genital infections and urinary tract infections were more common in the dapagliflozin groups than in the placebo+low-dose metformin group.

conclusionsDapagliflozin as monotherapy in treatment-naïve people with early Type 2 diabetes improved glycaemic control and reduced weight without increasing hypoglycaemia over 102 weeks. Dapagliflozin may provide an alternative initial pharmacotherapy in such people.

Indexed as

AdolescentAdultAgedBenzhydryl CompoundsBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleFemaleGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMaleMetforminBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID25381876

What OpenQuestion holds

Texttitle and abstract
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.