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Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus.
Diabetes Metab Res Rev. 2010 Oct; 26(7):540-9.DM

Abstract

BACKGROUND

Dipeptidyl peptidase-4 inhibitors improve glycaemic control in patients with type 2 diabetes mellitus when used as monotherapy or in combination with other anti-diabetic drugs (metformin, sulphonylurea, or thiazolidinedione). This 18-week, phase 3b, multicentre, double-blind, noninferiority trial compared the efficacy and safety of two dipeptidyl peptidase-4 inhibitors, saxagliptin and sitagliptin, in patients whose glycaemia was inadequately controlled with metformin.

METHODS

Adult type 2 diabetes mellitus patients (N = 801) with glycated haemoglobin (HbA(1c)) 6.5-10% on stable metformin doses (1500-3000 mg/day) were randomized 1 : 1 to add-on 5 mg saxagliptin or 100 mg sitagliptin once daily for 18 weeks. The primary efficacy analysis was a comparison of the change from baseline HbA(1c) at week 18 in per-protocol patients. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the HbA(1c) difference between treatments was < 0.3%.

RESULTS

The adjusted mean changes in HbA(1c) following the addition of saxagliptin or sitagliptin to stable metformin therapy were - 0.52 and - 0.62%, respectively. The between-group difference was 0.09% (95% confidence interval, - 0.01 to 0.20%), demonstrating noninferiority. Both treatments were generally well tolerated; incidence and types of adverse events were comparable between groups. Hypoglycaemic events, mostly mild, were reported in approximately 3% of patients in each treatment group. Body weight declined by a mean of 0.4 kg in both groups.

CONCLUSIONS

Saxagliptin added to metformin therapy was effective in improving glycaemic control in patients with type 2 diabetes mellitus inadequately controlled by metformin alone; saxagliptin plus metformin was noninferior to sitagliptin plus metformin, and was generally well tolerated.

Authors+Show Affiliations

University of Liège, Division of Diabetes, Nutrition and Metabolic Disorders and Clinical Pharmacology Unit, CHU Liège, Liège, Belgium. Andre.Scheen@chu.ulg.ac.beNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20824678

Citation

Scheen, André J., et al. "Efficacy and Safety of Saxagliptin in Combination With Metformin Compared With Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus." Diabetes/metabolism Research and Reviews, vol. 26, no. 7, 2010, pp. 540-9.
Scheen AJ, Charpentier G, Ostgren CJ, et al. Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes Metab Res Rev. 2010;26(7):540-9.
Scheen, A. J., Charpentier, G., Ostgren, C. J., Hellqvist, A., & Gause-Nilsson, I. (2010). Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. Diabetes/metabolism Research and Reviews, 26(7), 540-9. https://doi.org/10.1002/dmrr.1114
Scheen AJ, et al. Efficacy and Safety of Saxagliptin in Combination With Metformin Compared With Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus. Diabetes Metab Res Rev. 2010;26(7):540-9. PubMed PMID: 20824678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus. AU - Scheen,André J, AU - Charpentier,Guillaume, AU - Ostgren,Carl Johan, AU - Hellqvist,Asa, AU - Gause-Nilsson,Ingrid, PY - 2010/9/9/entrez PY - 2010/9/9/pubmed PY - 2011/1/29/medline SP - 540 EP - 9 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab Res Rev VL - 26 IS - 7 N2 - BACKGROUND: Dipeptidyl peptidase-4 inhibitors improve glycaemic control in patients with type 2 diabetes mellitus when used as monotherapy or in combination with other anti-diabetic drugs (metformin, sulphonylurea, or thiazolidinedione). This 18-week, phase 3b, multicentre, double-blind, noninferiority trial compared the efficacy and safety of two dipeptidyl peptidase-4 inhibitors, saxagliptin and sitagliptin, in patients whose glycaemia was inadequately controlled with metformin. METHODS: Adult type 2 diabetes mellitus patients (N = 801) with glycated haemoglobin (HbA(1c)) 6.5-10% on stable metformin doses (1500-3000 mg/day) were randomized 1 : 1 to add-on 5 mg saxagliptin or 100 mg sitagliptin once daily for 18 weeks. The primary efficacy analysis was a comparison of the change from baseline HbA(1c) at week 18 in per-protocol patients. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the HbA(1c) difference between treatments was < 0.3%. RESULTS: The adjusted mean changes in HbA(1c) following the addition of saxagliptin or sitagliptin to stable metformin therapy were - 0.52 and - 0.62%, respectively. The between-group difference was 0.09% (95% confidence interval, - 0.01 to 0.20%), demonstrating noninferiority. Both treatments were generally well tolerated; incidence and types of adverse events were comparable between groups. Hypoglycaemic events, mostly mild, were reported in approximately 3% of patients in each treatment group. Body weight declined by a mean of 0.4 kg in both groups. CONCLUSIONS: Saxagliptin added to metformin therapy was effective in improving glycaemic control in patients with type 2 diabetes mellitus inadequately controlled by metformin alone; saxagliptin plus metformin was noninferior to sitagliptin plus metformin, and was generally well tolerated. SN - 1520-7560 UR - https://www.unboundmedicine.com/medline/citation/20824678/Efficacy_and_safety_of_saxagliptin_in_combination_with_metformin_compared_with_sitagliptin_in_combination_with_metformin_in_adult_patients_with_type_2_diabetes_mellitus_ L2 - https://doi.org/10.1002/dmrr.1114 DB - PRIME DP - Unbound Medicine ER -