Open AccessSafety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2‐year study
Author(s) -
Seck T.,
Nauck M.,
Sheng D.,
Sunga S.,
Davies M. J.,
Stein P. P.,
Kaufman K. D.,
Amatruda J. M.
Publication year - 2010
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/j.1742-1241.2010.02353.x
Subject(s) - sitagliptin , glipizide , medicine , metformin , type 2 diabetes , diabetes mellitus , endocrinology , sitagliptin phosphate , gastroenterology
Summary Objectives: To evaluate the 2‐year safety and efficacy of adding sitagliptin or glipizide to ongoing metformin in patients with type 2 diabetes. Methods: Patients who were on a stable dose of metformin (≥ 1500 mg/day) for at least 8 weeks were randomised in a double‐blind manner to receive either sitagliptin 100 mg q.d. ( N = 588) or glipizide 5 mg/day (up‐titrated up to 20 mg/day based upon prespecified glycaemic criteria) ( N = 584). The efficacy analysis assessed the change in HbA 1c from baseline using the per‐protocol (PP) population. Results: For the PP cohort, mean baseline HbA 1c was 7.3% in both groups. After 2 years, the least squares (LS) mean change in HbA 1c from baseline [95% confidence interval (CI)] was −0.54% (−0.64, −0.45) with sitagliptin ( n = 248) and −0.51% (−0.60, −0.42) with glipizide ( n = 256). The rise in HbA 1c from week 24 to week 104 [i.e. coefficient of durability (COD)] was smaller with sitagliptin [COD (95% CI) 0.16%/year (0.10, 0.21)] compared with glipizide [0.26%/year (0.21, 0.31)]. The proportion of patients with an HbA 1c < 7% was 63% and 59% with sitagliptin and glipizide, respectively. The beta‐cell responsiveness to a meal challenge was maintained with sitagliptin and decreased with glipizide. The proportion of patients who reported hypoglycaemia was 5% with sitagliptin and 34% with glipizide [difference in proportions (95% CI) = −29% (−33, −25)]. Relative to baseline, sitagliptin was associated with weight loss (−1.6 kg) compared with weight gain (+0.7 kg) with glipizide. Conclusion: In patients with type 2 diabetes, adding sitagliptin to metformin monotherapy improved glycaemic control over 2 years, similar to the glucose‐lowering efficacy observed with adding glipizide, but with greater durability and generally better maintenance of beta‐cell function. Sitagliptin was generally well tolerated with a lower risk of hypoglycaemia and weight loss compared with weight gain observed with glipizide.