Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes*
- 15 September 2008
- journal article
- research article
- Published by Wiley in Diabetes, Obesity and Metabolism
- Vol. 10 (10), 959-969
- https://doi.org/10.1111/j.1463-1326.2007.00839.x
Abstract
Aim: To assess the addition of sitagliptin to ongoing metformin therapy in patients with type 2 diabetes who were inadequately controlled [haemoglobin A1c (HbA1c) 7–11%] on metformin monotherapy. Methods: Patients (n = 273) on metformin (≥1500 mg/day) were randomized to receive the addition of once‐daily placebo, sitagliptin 100 mg or rosiglitazone 8 mg in a 1 : 1 : 1 ratio for 18 weeks. The efficacy analysis was based on the all‐patients‐treated population using an analysis of co‐variance with change in HbA1c from baseline as the primary endpoint. Results: The mean baseline HbA1c was 7.7% for the entire cohort. After 18 weeks, both active add‐on therapies led to greater improvements in HbA1c from baseline: −0.73% for sitagliptin (p < 0.001 vs. placebo) and −0.79% for rosiglitazone compared with −0.22% for placebo. No difference was observed between the sitagliptin and rosiglitazone treatments (0.06% [95% confidence interval (CI): −0.14 to 0.25]). The proportion of patients achieving an HbA1c < 7% was greater with sitagliptin (55%) and rosiglitazone (63%) compared with placebo (38%). Body weight increased from baseline with rosiglitazone (1.5 kg) compared with body weight reduction with sitagliptin (−0.4 kg) and placebo (−0.8 kg). The difference in body weight between the sitagliptin and rosiglitazone groups was 1.9 kg (95% CI: 1.3–2.5). In a prespecified analysis, the proportion of patients experiencing a greater than 3‐kg increase in body weight was 21% in the rosiglitazone group compared with 2% in both the sitagliptin and placebo groups. Both active treatments were generally well tolerated, with no increased risk of hypoglycaemia or gastrointestinal adverse events compared with placebo. Conclusions: In this 18‐week study, the addition of sitagliptin was effective and well tolerated in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Treatment with sitagliptin produced similar reductions in HbA1c compared with the addition of rosiglitazone.Keywords
This publication has 24 references indexed in Scilit:
- Efficacy and safety of the dipeptidyl peptidase‐4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double‐blind, non‐inferiority trialDiabetes, Obesity and Metabolism, 2007
- Effect of adding sitagliptin, a dipeptidyl peptidase‐4 inhibitor, to metformin on 24‐h glycaemic control and β‐cell function in patients with type 2 diabetesDiabetes, Obesity and Metabolism, 2006
- Glycemic Durability of Rosiglitazone, Metformin, or Glyburide MonotherapyThe New England Journal of Medicine, 2006
- Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin AloneDiabetes Care, 2006
- The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetesThe Lancet, 2006
- DPP-4 inhibitors and their potential role in the management of type 2 diabetesInternational Journal of Clinical Practice, 2006
- Oral Antidiabetic AgentsDrugs, 2005
- Rosiglitazone plus metformin: combination therapy for Type 2 diabetesExpert Opinion on Pharmacotherapy, 2004
- Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34)The Lancet, 1998
- Relationship between lactate dehydrogenase and myeloperoxidase levels in human gingival crevicular fluid and clinical and microbial measurementsJournal of Clinical Periodontology, 1988