December 29, 2008Diabetes Obesity and Metabolism
Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy
Why the study?
Does alogliptin reduce HbA1c in adult patients with type 2 diabetes inadequately controlled by glyburide monotherapy?
Population
500 adult patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy, mean age 57…
Comparison
Alogliptin 12.5 mg or 25 mg added to glyburide… vs Placebo added to glyburide for 26 weeks
Design
RCT, randomly assigned, double-blind
Follow-up
26 weeks
Authors
Discussion
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Member takes
Implication
Supports adding alogliptin to glyburide in T2D; confirms DPP-4 inhibitor efficacy on sulfonylurea background.
Key Points
- To evaluate the efficacy and safety of adding the DPP-4 inhibitor alogliptin to glyburide in patients with type 2 diabetes inadequately controlled by sulphonylurea monotherapy.
- Adults aged 18–80 years with type 2 diabetes and inadequate glycemic control underwent a 4-week run-in period with open-label glyburide plus single-blind placebo.
- A total of 500 patients were randomly assigned to 26 weeks of double-blind treatment with alogliptin 12.5 mg (n = 203), alogliptin 25 mg (n = 198), or placebo (n = 99).
- The primary endpoint was change in HbA1c from baseline to week 26, alongside secondary assessments of fasting glucose, beta-cell function, weight, and adverse events.
- Least squares mean reductions in HbA1c at week 26 were -0.38% with alogliptin 12.5 mg and -0.52% with alogliptin 25 mg compared to +0.01% with placebo (p < 0.001 for both).
- Target HbA1c ≤ 7.0% was achieved by 34.8% of patients receiving alogliptin 25 mg versus 18.2% on placebo (p = 0.002), and reductions ≥ 0.5% occurred in 47.3% (12.5 mg) and 50.5% (25 mg) versus 26.3% on placebo (p < 0.001).
- Incidence of hypoglycemia was 15.8% for alogliptin 12.5 mg, 9.6% for alogliptin 25 mg, and 11.1% for placebo, with overall adverse events occurring in 63–64% versus 54%.
Structured PICO
Does alogliptin reduce HbA1c in adult patients with type 2 diabetes inadequately controlled by glyburide monotherapy?
P
Population
500 adult patients (18-80 years of age) with type 2 diabetes inadequately controlled by sulphonylurea monotherapy, mean age 57 years, 52% women, 71% white.
I
Intervention
Alogliptin 12.5 mg or 25 mg added to glyburide for 26 weeks
C
Comparator
Placebo added to glyburide for 26 weeks
O
Outcome
Change from baseline to week 26 in glycosylated haemoglobin (HbA1c)surrogate
The addition of alogliptin to glyburide significantly improves glycemic control in patients with type 2 diabetes inadequately controlled by sulfonylurea monotherapy, without increasing the risk of hypoglycemia.
Cite This Study
Pratley et al. (2008) studied this question.