Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: A 52-week, randomized, double-blind, active-controlled, parallel-group study

Diabetes, Obesity and Metabolism

Volumn 13, Issue 12, 2011, Pages 1088-1096

  Bosi, E ^a   Ellis, G C ^b   Wilson, C A ^c   Fleck, P R ^c  

^a VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^b Helderberg Diabetes and Medical Centre   (South Africa)

^c TAKEDA PHARMACEUTICALS   (United States)

Author keywords

Combination therapy; Dipeptidylpeptidase 4; DPP 4 inhibitor; Glycaemic control; Metformin; Pioglitazone; Thiazolidinedione; Triple therapy; Type 2 diabetes

Indexed keywords

ALOGLIPTIN; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PIOGLITAZONE;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; B LYMPHOCYTE; BACKACHE; BRONCHITIS; CONTROLLED STUDY; DIARRHEA; DIET RESTRICTION; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DYSLIPIDEMIA; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INFLUENZA; LYMPHOCYTE FUNCTION; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PERIPHERAL EDEMA; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

EID: 80055037047     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2011.01463.x     Document Type: Article

References (25)

1. DeFronzo RA. Banting lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009; 58: 773-795.
2. Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412.
3. Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving in U.S. adults? Diabetes Care 2008; 31: 81-86.
4. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999; 281: 2005-2012.
5. Goodarzi MO, Bryer-Ash M. Metformin revisited: re-evaluation of its properties and role in the pharmacopoeia of modern antidiabetic agents. Diabetes Obes Metab 2005; 7: 654-665.
6. Martens FM, Visseren FL, Lemay J, de Koning EJ, Rabelink TJ. Metabolic and additional vascular effects of thiazolidinediones. Drugs 2002; 62: 1463-1480.
7. Wajchenberg BL. β-cell failure in diabetes and preservation by clinical treatment. Endocr Rev 2007; 28: 187-218.
8. Staels B. Metformin and pioglitazone: effectively treating insulin resistance. Curr Med Res Opin 2006; 22(Suppl. 2): S27-37.
9. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
10. Rodbard HW, Jellinger PS, Davidson JA et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009; 15: 540-559.
11. Lovshin JA, Drucker DJ. Incretin-based therapies for type 2 diabetes mellitus. Nat Rev Endocrinol 2009; 5: 262-269.
12. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008; 31: 2315-2317.
13. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009; 63: 46-55.
14. Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009; 25: 2361-2371.
15. Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care 2010; 33: 2406-2408.
16. Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q. Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009; 11: 167-176.
17. Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab 2009; 11: 1145-1152.
18. Ahrén B. Novel combination treatment of type 2 diabetes DPP-4 inhibition + metformin. Vasc Health Risk Manag 2008; 4: 383-394.
19. Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care 2007; 30: 890-895.
20. DeFronzo RA, Hissa MN, Garber AJ et al. Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care 2009; 32: 1649-1655.
21. Mikhail N. Combination therapy with DPP-4 inhibitors and pioglitazone in type 2 diabetes: theoretical consideration and therapeutic potential. Vasc Health Risk Manag 2008; 4: 1221-1227.
22. Hollander P, Li J, Allen E, Chen R, CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab 2009; 94: 4810-4819.
23. DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley R. Effect of alogliptin combined with pioglitazone on glycemic control in metformin-treated patients with type 2 diabetes (Abstract). Diabetes 2009; 58(Suppl. 1): A519.
24. Dobs A, Goldstein BJ, Wieczorek L et al. Triple combination therapy with sitagliptin, metformin, and rosiglitazone improves glycemic control in patients with type 2 diabetes (Abstract). Diabetes 2008; 57(Suppl. 1): A595-A596.
25. Bloomgarden ZT, Dodis R, Viscoli CM, Holmboe ES, Inzucchi SE. Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: a meta-regression analysis. Diabetes Care. 2006; 29: 2137-2139.