Metformin × adverse events & safety

TrialDiabetes, obesity & metabolism2023

Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24-week, randomized, double-blind, placebo-controlled trial.

Yuan-Di Halvorsen et al.PubMed ↗Publisher ↗

  • Bexagliflozin plus metforminlooks good hereLower long-term blood sugar, lower systolic blood pressure, lower fasting blood sugar.Randomised, small.

What the trial testedrandomised · 317 people · 2023

Randomised comparison

Probably lowered glycemic control

−1.09percentage points−1.24 to −0.94

As reported

difference −1.09 %, 95% CI −1.24 to −0.94

Randomised vs placebo plus metformin

Probably lowered long-term blood sugar

−0.53percentage points−0.74 to −0.32

bexagliflozin plus metformin vs placebo plus metformin

As reported

difference −0.53 %, 95% CI −0.74 to −0.32 · the paper's word: change in glycated haemoglobin (HbA1c) from baseline to week 24

Randomised vs placebo plus metformin

Probably lowered long-term blood sugar

−0.70percentage points−0.92 to −0.48

bexagliflozin plus metformin vs placebo plus metformin

As reported

difference −0.70 %, 95% CI −0.92 to −0.48 · the paper's word: change in glycated haemoglobin (HbA1c) from baseline to week 24

Randomised vs placebo plus metformin

Probably lowered systolic blood pressure

−7.07mmHg−9.83 to −4.32

bexagliflozin plus metformin vs placebo plus metformin

As reported

difference −7.07 mmHg, 95% CI −9.83 to −4.32

+3 more in the walkthrough ↓

Who was studied, and how

317people with type 2 diabetes, in this paper

The trial randomly assignedassigned by chance

bexagliflozin plus metformin
placebo plus metformin

Probably lowered long-term blood sugar−0.53

Probably lowered systolic blood pressure−7.07

Probably lowered fasting blood sugar−1.35

randomised

the abstract, start to end

The mean change in HbA1c was -1.09% (95% CI -1.24%, -0.94%) in the bexagliflozin arm and -0.56% (-0.71%, -0.41%) in the placebo arm, a difference of -0.53% (-0.74%, -0.32%; p < .0001).

the intergroup difference was -0.70% (-0.92, -0.48; p < .0001).

The open label group change in HbA1c was -2.82% (-3.23%, -2.41%).

plasma glucose and body mass were -7.07 mmHg (-9.83, -4.32; p < .0001), -1.35 mmol/L (-1.83, -0.86; p < .0001) and -2.51 kg (-3.45, -1.57; p < .0001).

← favours treatmentfavours comparator →
could be chance
Glycemic control
−1.09−1.24 to −0.94
Change in glycated haemoglobin (HbA1c) from baseline to week 24bexagliflozin plus metformin vs placebo plus metformin
−0.53−0.74 to −0.32
Change in glycated haemoglobin (HbA1c) from baseline to week 24bexagliflozin plus metformin vs placebo plus metformin
−0.70−0.92 to −0.48
Change in glycated haemoglobin (HbA1c) from baseline to week 24bexagliflozin plus metformin (open label arm), in participants with HbA1c >10.5%
−2.82−3.23 to −2.41
Systolic blood pressure (SBP)bexagliflozin plus metformin vs placebo plus metformin
−7.07−9.83 to −4.32
Fasting plasma glucosebexagliflozin plus metformin vs placebo plus metformin
−1.35−1.83 to −0.86
Body massbexagliflozin plus metformin vs placebo plus metformin
−2.51−3.45 to −1.57
MetforminSGLT2 inhibitorsGlycemic controlBody weight & compositionBlood pressureAdverse events & safety

Metformin × adverse events & safetyharms?mixed

unlikelylikely
0.270.29 without it

SGLT2 inhibitors × adverse events & safetyharms?mixed

unlikelylikely
0.000.00 without it

SGLT2 inhibitors × glycemic controlhelps?replicated

unlikelylikely
0.920.92 without it
← favours treatmentfavours comparator →
this papermore certainless certain
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8 papers cite it

2023
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Full record →Abstract, authors, funding and every citing paper · PMID 37409573