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

  1. J. Rosenstock1,*,
  2. M. S. Rendell2,
  3. J. L. Gross3,
  4. P. R. Fleck4,
  5. C. A. Wilson4,
  6. Q. Mekki4

Article first published online: 16 SEP 2009

DOI: 10.1111/j.1463-1326.2009.01124.x

Issue

Diabetes, Obesity and Metabolism

Diabetes, Obesity and Metabolism

Volume 11, Issue 12, pages 1145–1152, December 2009

Additional Information

How to Cite

Rosenstock, J., Rendell, M. S., Gross, J. L., Fleck, P. R., Wilson, C. A. and Mekki, Q. (2009), Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes, Obesity and Metabolism, 11: 1145–1152. doi: 10.1111/j.1463-1326.2009.01124.x

Author Information

  1. 1

    Dallas Diabetes and Endocrine Center, Dallas, TX, USA

  2. 2

    Creighton Diabetes Center, Omaha, NE, USA

  3. 3

    Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil

  4. 4

    Takeda Global Research & Development Center, Inc., Lake Forest, IL, USA

*Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center at Medical City, 7777 Forest Lane, C-685 Dallas, TX 75230, USA. E-mail: juliorosenstock@dallasdiabetes.com

Publication History

  1. Issue published online: 10 NOV 2009
  2. Article first published online: 16 SEP 2009
  3. Received 14 April 2009; returned for revision 22 May 2009; revised version accepted 3 July 2009

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Keywords:

  • alogliptin;
  • dipeptidyl peptidase 4 inhibitor;
  • insulin type 2 diabetes

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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