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Clinical Summary

Type 2 diabetes: efficacy and safety of initial triple therapy

Takeaway

  • In drug-naïve patients with type 2 diabetes (T2D) and high baseline glycated haemoglobin (HbA1c), initial triple combination therapy with metformin, sitagliptin, and lobeglitazone demonstrated better efficacy and safety compared with conventional stepwise approach of sequential dose escalation with metformin and sulfonylurea.

Why this matter

  • Triple combination therapy with dipeptidyl peptidase-4 inhibitor to preserve β-cells and with thiazolidinedione and metformin to lower the burden on the β-cells may be a good therapeutic option for T2D patients with high HbA1c levels.

Study design

  • 100 drug-naïve patients with T2D who initiated initial triple therapy (1000 mg/day metformin, 100 mg/day sitagliptin and 0.5 mg/day lobeglitazone) were matched with 100 patients who initiated conventional stepwise therapy (2-6 mg/day glimepiride+1000-2000 mg/day metformin) for 12 months.
  • Primary outcome: change in HbA1c level from baseline to 12 months.
  • Funding: Seoul National University Bundang Hospital.

Key results

  • After 12 months, HbA1c levels significantly reduced in the triple therapy vs conventional therapy group (6.7%±1.3% vs 7.3%±1.2%; P<.001).
  • Higher proportion of patients achieved HbA1c levels ≤6.5% (69.8% vs 52.4%; P=.027) and <7.0% (58.1% vs 36.9%; P=.006) in the triple therapy vs conventional therapy group.
  • Triple vs conventional therapy showed significant improvement in indexes related to:
    • homeostasis model assessment of β-cell function,
    • homeostasis model assessment of insulin resistance and
    • urinary albumin-creatinine ratio (P<.05 for all).
  • Hypoglycaemia was more frequently reported in conventional (13.1%; P=.002) vs triple therapy group (4.8%; P=.057).

Limitations

  • Study did not use same drugs and number in the comparison.

References


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