Comparative efficacy and safety of oral hypoglycaemic drugs as adjunctive therapy in the management of type 1 diabetes mellitus: A systematic review and meta‐analysis
Authors' conclusion
OHDs as adjunctive therapy in T1DM significantly improve glycaemic control and reduce insulin requirements. However, their use is associated with notable safety concerns, particularly ketoacidosis and other adverse events. Clinicians must conduct thorough risk assessments and tailor treatment plans to individual patient profiles to balance efficacy and safety. Future research should focus on long-term outcomes and strategies to mitigate adverse effects.
Study context
- Population
- Patients with T1D on insulin therapy; Randomized clinical trials (RCTs) published up to October 31, 2024 (PubMed, Embase, Cochrane Library)
- Participants
- 8,664 patients51 RCTs
- Comparison
- Oral hypoglycaemic drugs adjunct to insulin vs placebo
- Outcome
- Changes in HbA1c and hypoglycaemia risk
Methodological detailsindirect comparisons, subgroup analyses
- Indirect comparisons
- Subgroup analyses
Pooled result
As reported in the abstract
Weighted mean difference (WMD) (HbA1c)
−0.32 %
P < 0.001
Oral hypoglycaemic drugs (OHDs)
Relative risk (hypoglycaemia)
1.01
P = 0.08
did not increase risk
Further pooled results
| Outcome | Estimate | P value |
|---|---|---|
| FPG | WMD −0.91 mmol/L | P < 0.001 |
| Postprandial plasma glucose | WMD −2.08 mmol/L | P < 0.001 |
| Daily insulin dosage | WMD −4.88 IU/day | P < 0.001 |
| Body weight | WMD −1.89 kg | P < 0.001 |
| TIR 3.9-10.0 mmol/L | WMD 6.04 % | P = 0.04 |
| BMINo significant change | WMD −0.18 kg/m² | P = 0.08 |
| HbA1c reduction, indirect comparison: AGI vs thiazolidinedionesFavoured AGI | mean difference −0.46 % | P < 0.001 |
FPG reduction, subgroup: adults vs children/adolescents
- Adults: WMD
- −1.15 mmol/L
- Children/adolescents: WMD
- −0.26 mmol/L
- Greater reduction in adults; p of group difference
- p of group difference = 0.02
Safety
| Outcome | Estimate | P value |
|---|---|---|
| Hypoglycaemia subtypesOHDs vs Placebo | RR (severe hypoglycaemia) 0.95 | P = 0.73 |
| Hypoglycaemia subtypesOHDs vs Placebo | RR (nocturnal hypoglycaemia) 0.97 | P = 0.24 |
| Adverse eventsOHDs vs Placebo | RR (serious adverse events) 1.30 | P = 0.005 |
| Adverse eventsOHDs vs Placebo | RR (discontinuation due to adverse events) 1.88 | P < 0.001 |
| Adverse eventsOHDs vs Placebo | RR (genital tract infection) 3.30 | P < 0.001 |
| Adverse eventsOHDs vs Placebo | RR (gastrointestinal side effects) 1.98 | P < 0.001 |
| Adverse eventsOHDs vs Placebo | RR (ketoacidosis) 3.14 | P < 0.001 |
Original publication
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