TY - JOUR

T1 - The effects of sodium-glucose co-transporter 2 inhibitors in patients with type 2 diabetes

T2 - protocol for a systematic review with meta-analysis of randomised trials

AU - Storgaard, Heidi

AU - Gluud, Lise Lotte

AU - Christensen, Mikkel

AU - Knop, Filip Krag

AU - Vilsbøll, Tina

PY - 2014

Y1 - 2014

N2 - INTRODUCTION: Sodium-glucose co-transporter 2 inhibitors (SGLT-2i) increase urinary glucose excretion through a reduced renal glucose reabsorption. We plan to perform a systematic review of SGLT-2i for treatment of type 2 diabetes.METHODS AND ANALYSIS: A systematic review with meta-analyses of randomised clinical trials on SGLT-2i versus placebo, other oral glucose lowering drugs or insulin for patients with type 2 diabetes will be performed. The primary end point will be the glycated haemoglobin. Secondary end points will include changes in body weight, body mass index, fasting plasma glucose, plasma cholesterol, kidney and liver blood tests, blood pressure and adverse events. Electronic (the Cochrane Library, MEDLINE, EMBASE and the Science Citation Index) and manual searches will be performed. Meta-analyses will be performed and the results presented as mean differences for continuous outcomes and risk differences for dichotomous outcomes, both with 95% CIs. Subgroup, sensitivity, regression and sequential analyses will be performed to evaluate intertrial heterogeneity, bias and the robustness of results due to cumulative testing.ETHICS AND DISSEMINATION: The study will contribute to the knowledge regarding the beneficial and harmful effects of SGLT-2i in patients with type 2 diabetes. We plan to publish the study irrespective of the results.RESULTS: The study will be disseminated by peer-review publication and conference presentation.TRIAL REGISTRATION NUMBER: PROSPERO CRD42014008960

AB - INTRODUCTION: Sodium-glucose co-transporter 2 inhibitors (SGLT-2i) increase urinary glucose excretion through a reduced renal glucose reabsorption. We plan to perform a systematic review of SGLT-2i for treatment of type 2 diabetes.METHODS AND ANALYSIS: A systematic review with meta-analyses of randomised clinical trials on SGLT-2i versus placebo, other oral glucose lowering drugs or insulin for patients with type 2 diabetes will be performed. The primary end point will be the glycated haemoglobin. Secondary end points will include changes in body weight, body mass index, fasting plasma glucose, plasma cholesterol, kidney and liver blood tests, blood pressure and adverse events. Electronic (the Cochrane Library, MEDLINE, EMBASE and the Science Citation Index) and manual searches will be performed. Meta-analyses will be performed and the results presented as mean differences for continuous outcomes and risk differences for dichotomous outcomes, both with 95% CIs. Subgroup, sensitivity, regression and sequential analyses will be performed to evaluate intertrial heterogeneity, bias and the robustness of results due to cumulative testing.ETHICS AND DISSEMINATION: The study will contribute to the knowledge regarding the beneficial and harmful effects of SGLT-2i in patients with type 2 diabetes. We plan to publish the study irrespective of the results.RESULTS: The study will be disseminated by peer-review publication and conference presentation.TRIAL REGISTRATION NUMBER: PROSPERO CRD42014008960

U2 - 10.1136/bmjopen-2014-005378

DO - 10.1136/bmjopen-2014-005378

M3 - Journal article

C2 - 25232561

VL - 4

SP - 1

EP - 5

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 8

M1 - e005378

ER -