The efficacy of dapagliflozin combined with hypoglycemic drugs in treating type 2
diabetes: protocol for meta-analysis of randomized controlled trials.
Author(s): Sun YN, Zhou Y, Chen X, Che WS, Leung SW(1).
Affiliation(s): Author information:
(1)State Key Laboratory of Quality Research in Chinese Medicine, Institute of
Chinese Medical Sciences, University of Macau, Macao, China. siu@inf.ed.ac.uk.
Publication date & source: 2013, Syst Rev. , 2:103
BACKGROUND: Dapagliflozin is a first-in-class oral sodium glucose co-transporter
2 (SGLT2) inhibitor. It is often used in combination with conventional
anti-diabetic drugs such as metformin, glimepiride, and insulin in treating type
2 diabetes (T2D). It not only reduces glucose reabsorption in the kidney but also
increases renal glucose excretion. Some studies found the actions of
dapagliflozin independent of insulin and free from risk of weight gain. This
meta-analysis aims to evaluate whether dapagliflozin is synergistic with other
anti-diabetic drugs without risk of weight gain.
METHODS/DESIGN: This meta-analysis will include the randomized controlled trials
(RCT) evaluating the efficacy of dapagliflozin as an add-on drug in treating T2D
for >8 weeks with the outcome measures glycosylated hemoglobin (HbA1c), fasting
plasma glucose (FPG) and body weight. Information of relevant RCTs will be
retrieved from major databases including PubMed, Cochrane Library, Embase,
ClinicalTrials.gov, and Google Scholar according to a pre-specified search
strategy. Google and manual search will find other unpublished reports and
supplementary data. Eligible RCTs will be selected according to pre-specified
inclusion and exclusion criteria. Data will be extracted and input into a
pre-formatted spreadsheet. The Cochrane risk of bias tool will be used to assess
the quality of the eligible RCTs. Meta-analysis based on the random-effects model
will be conducted to compare the changes of HbA1c (%), FPG (mmol/L), and body
weight (kg) between dapagliflozin arm and placebo arm. Publication bias will be
evaluated with a funnel plot and the Egger's test. Heterogeneity will be assessed
with the I2 statistics. Sensitivity analysis will be conducted on follow-up
periods. The evidential quality of the findings will be assessed with the GRADE
profiler.
DISCUSSION: The findings of this meta-analysis will be important to clinicians,
patients, and health policy-makers regarding the use of dapagliflozin in T2D
treatment.
STUDY REGISTRATION: PROSPERO registration number: CRD42013005034.
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