Table 2

GRADE assessment of the outcomes (HbA1c, FPG and body weight)

10 mg Dapagliflozin arm compared with PLA arm for GRADE
Patient or population: patients with type 2 diabetes mellitus
Intervention: 10 mg dapagliflozin combined with antidiabetic drugs
Comparison: placebo combined with antidiabetic drugs
OutcomesIllustrative comparative risks* (95% CI)Number of participants
(studies)
Quality of the evidence (GRADE)
Assumed riskCorresponding risk
Placebo combined with antidiabetic drugs10 mg Dapagliflozin combined with antidiabetic drugs
HbA1c (%)
Follow-up: 12–104 weeks
The mean HbA1c ranged across control groups from
1.44 to 0.09%
The mean HbA1c in the intervention groups was
0.52 lower (0.6 to 0.45 lower)
3986
(14 studies)
⊕⊕⊕⊕
High
FPG (mmol/L)
Follow-up: 12–104 weeks
The mean FPG ranged across control groups from
1.93 to 0.99 mmol/L
The mean FPG in the intervention groups was
1.13 lower (1.33 to 0.93 lower)
3620
(12 studies)
⊕⊕⊕⊕
High
Body weight (kg)
Follow-up: 12–104 weeks
The mean body weight ranged across control groups from
2.12 to 2.99 kg
The mean body weight in the intervention groups was
2.10 lower (2.32 to 1.88 lower)
4008
(14 studies)
⊕⊕⊕⊝
Moderate
  • GRADE Working Group grades of evidence.

  • High quality: Further research is very unlikely to change our confidence in the estimate of effect.

  • Moderate quality Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

  • Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

  • Very low quality: We are very uncertain about the estimate.

  • *The basis for the assumed risk (eg, the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

  • FPG, fasting plasma glucose; HbA1c, glycosylated haemoglobin; PLA, placebo.