Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia

J. Rosenstock, M. S. Rendell, J. L. Gross, P. R. Fleck, C. A. Wilson, Q. Mekki

Research output: Contribution to journalArticle

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Abstract

Aims: To assess the efficacy and safety of alogliptin added to insulin in patients with type 2 diabetes inadequately controlled with insulin alone or combined with metformin. Methods: In this 26-week, double-blind, placebo-controlled study, 390 patients were randomized to receive alogliptin 12.5 mg (n = 131), alogliptin 25 mg (n = 129) or placebo (n = 130) once daily, as add-on to stable insulin therapy with or without metformin. The primary endpoint was change in haemoglobin A1C (HbA1C) at week 26. Results: At week 26, mean HbA1C changes from the mean baseline value of 9.3% were significantly greater for alogliptin 12.5 mg (-0.63 ± 0.08%) and alogliptin 25 mg (-0.71 ± 0.08%) than placebo (-0.13 ± 0.08%; p <0.001). Significantly greater proportions of patients receiving alogliptin 12.5 or 25 mg than placebo had HbA1C decreases of ≥0.5, ≥1.0 and ≥1.5%. Insulin doses remained unchanged, and there were no differences in the proportions of patients experiencing hypoglycaemia among placebo (24%), alogliptin 12.5 mg (27%) and alogliptin 25 mg (27%). Mean weight increases from baseline at week 26 were similar for placebo (0.6 ± 0.2 kg), alogliptin 12.5 mg (0.7 ± 0.2 kg) and alogliptin 25 mg (0.6 ± 0.2 kg). Incidences of overall adverse events, and of gastrointestinal, dermatological and infection-related events, were similar among groups. Conclusions: Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia. Further studies are warranted to explore the role of alogliptin added to optimized basal insulin regimens.

Original languageEnglish
Pages (from-to)1145-1152
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number12
DOIs
StatePublished - Dec 2009

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Hypoglycemia
Type 2 Diabetes Mellitus
Weight Gain
Insulin
Placebos
Metformin
Therapeutics
Hemoglobins
alogliptin
Incidence
Safety
Weights and Measures

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. / Rosenstock, J.; Rendell, M. S.; Gross, J. L.; Fleck, P. R.; Wilson, C. A.; Mekki, Q.

In: Diabetes, Obesity and Metabolism, Vol. 11, No. 12, 12.2009, p. 1145-1152.

Research output: Contribution to journalArticle

Rosenstock, J. ; Rendell, M. S. ; Gross, J. L. ; Fleck, P. R. ; Wilson, C. A. ; Mekki, Q. / Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. In: Diabetes, Obesity and Metabolism. 2009 ; Vol. 11, No. 12. pp. 1145-1152.
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abstract = "Aims: To assess the efficacy and safety of alogliptin added to insulin in patients with type 2 diabetes inadequately controlled with insulin alone or combined with metformin. Methods: In this 26-week, double-blind, placebo-controlled study, 390 patients were randomized to receive alogliptin 12.5 mg (n = 131), alogliptin 25 mg (n = 129) or placebo (n = 130) once daily, as add-on to stable insulin therapy with or without metformin. The primary endpoint was change in haemoglobin A1C (HbA1C) at week 26. Results: At week 26, mean HbA1C changes from the mean baseline value of 9.3{\%} were significantly greater for alogliptin 12.5 mg (-0.63 ± 0.08{\%}) and alogliptin 25 mg (-0.71 ± 0.08{\%}) than placebo (-0.13 ± 0.08{\%}; p <0.001). Significantly greater proportions of patients receiving alogliptin 12.5 or 25 mg than placebo had HbA1C decreases of ≥0.5, ≥1.0 and ≥1.5{\%}. Insulin doses remained unchanged, and there were no differences in the proportions of patients experiencing hypoglycaemia among placebo (24{\%}), alogliptin 12.5 mg (27{\%}) and alogliptin 25 mg (27{\%}). Mean weight increases from baseline at week 26 were similar for placebo (0.6 ± 0.2 kg), alogliptin 12.5 mg (0.7 ± 0.2 kg) and alogliptin 25 mg (0.6 ± 0.2 kg). Incidences of overall adverse events, and of gastrointestinal, dermatological and infection-related events, were similar among groups. Conclusions: Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia. Further studies are warranted to explore the role of alogliptin added to optimized basal insulin regimens.",
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AB - Aims: To assess the efficacy and safety of alogliptin added to insulin in patients with type 2 diabetes inadequately controlled with insulin alone or combined with metformin. Methods: In this 26-week, double-blind, placebo-controlled study, 390 patients were randomized to receive alogliptin 12.5 mg (n = 131), alogliptin 25 mg (n = 129) or placebo (n = 130) once daily, as add-on to stable insulin therapy with or without metformin. The primary endpoint was change in haemoglobin A1C (HbA1C) at week 26. Results: At week 26, mean HbA1C changes from the mean baseline value of 9.3% were significantly greater for alogliptin 12.5 mg (-0.63 ± 0.08%) and alogliptin 25 mg (-0.71 ± 0.08%) than placebo (-0.13 ± 0.08%; p <0.001). Significantly greater proportions of patients receiving alogliptin 12.5 or 25 mg than placebo had HbA1C decreases of ≥0.5, ≥1.0 and ≥1.5%. Insulin doses remained unchanged, and there were no differences in the proportions of patients experiencing hypoglycaemia among placebo (24%), alogliptin 12.5 mg (27%) and alogliptin 25 mg (27%). Mean weight increases from baseline at week 26 were similar for placebo (0.6 ± 0.2 kg), alogliptin 12.5 mg (0.7 ± 0.2 kg) and alogliptin 25 mg (0.6 ± 0.2 kg). Incidences of overall adverse events, and of gastrointestinal, dermatological and infection-related events, were similar among groups. Conclusions: Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia. Further studies are warranted to explore the role of alogliptin added to optimized basal insulin regimens.

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