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A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy.

ABSTRACT: To compare the safety and efficacy of saxagliptin 2.5 mg twice daily (BID) versus placebo add-on therapy to metformin immediate release (IR) in patients with type 2 diabetes and inadequate glycemic control with metformin alone.This multicenter, 12-week, double-blind, parallel-group trial enrolled adult outpatients with type 2 diabetes (glycated hemoglobin [HbA1c] 7.0%-10.0%) on stable metformin IR monotherapy (?1500 mg, BID for ?8 weeks). Patients were randomized to double-blind saxagliptin 2.5 mg BID or placebo added on to metformin IR following a 2-week, single-blind, placebo add-on therapy lead-in period. The primary end point was the change from baseline to week 12 in HbA1c. Key secondary end points included change from baseline to week 12 in fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7.0% or HbA1c???6.5% at week 12. Efficacy was analyzed in all patients who received randomized study drug with ?1 postbaseline assessment. Safety was assessed in all treated patients.In total, 74 patients were randomized to double-blind saxagliptin add-on therapy and 86 to placebo add-on therapy. At week 12, least-squares mean changes (95% CI) from baseline HbA1c (adjusted for baseline HbA1c) were significantly greater (P?=?0.006) in the saxagliptin?+?metformin group -0.56% (-0.74% to -0.38%) versus the placebo?+?metformin group -0.22% (-0.39% to -0.06%). Adjusted mean changes from baseline in FPG were numerically greater with saxagliptin versus placebo; the difference (95% CI) -9.5 mg/dL (-21.7 to 2.7) was not statistically significant (P?=?0.12). A numerically greater proportion of patients in the saxagliptin group than the placebo group achieved HbA1c?

SUBMITTER: White JL

PROVIDER: S-EPMC3946011 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy.

White Judith L JL Buchanan Patricia P Li Jia J Frederich Robert R

BMC endocrine disorders 20140224

<h4>Background</h4>To compare the safety and efficacy of saxagliptin 2.5 mg twice daily (BID) versus placebo add-on therapy to metformin immediate release (IR) in patients with type 2 diabetes and inadequate glycemic control with metformin alone.<h4>Methods</h4>This multicenter, 12-week, double-blind, parallel-group trial enrolled adult outpatients with type 2 diabetes (glycated hemoglobin [HbA1c] 7.0%-10.0%) on stable metformin IR monotherapy (≥1500 mg, BID for ≥8 weeks). Patients were randomiz ...[more]

PMID: 24565221

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Project description:BackgroundImpaired insulin activity in women with polycystic ovary syndrome might differ from that seen in type 2 diabetes mellitus without polycystic ovary syndrome. This study was designed to compare the effects of treatment with metformin, saxagliptin, and their combination in newly diagnosed women with type 2 diabetes mellitus and polycystic ovary syndrome in China.MethodsA total of 75 newly diagnosed patients from Shanghai, China with type 2 diabetes mellitus and polycystic ovary syndrome were included in this randomized, parallel, open-label study. All patients received treatment for 24 weeks with metformin, saxagliptin, or their combination. Patients were allocated to one of three treatment groups by a computer-generated code that facilitated equal patient distribution of 25 patients per group. The primary outcome was a change in glycemic control and ?-cell function.ResultsA total of 63 patients completed the study (n?=?21, for each group). The reduction in hemoglobin A1c was significant in the combination group, compared to the monotherapy groups (saxagliptin vs. combination treatment vs. metformin: -?1.1 vs. -1.3 vs. -1.1%, P?=?0.016), whereas it was comparable between the metformin and saxagliptin groups (P?>?0.05). Saxagliptin, metformin, and the combination treatment significantly reduced the homeostasis model assessment- insulin resistance index and increased the deposition index (P?<?0.01 for all). However, no significant change was observed in the homeostasis model assessment- ?-cell function among the metformin and combination groups, and no significant changes were observed in the insulinogenic index among all three groups (P?>?0.05 for all). In addition, saxagliptin and metformin treatments significantly reduced body mass index and high-sensitivity C-reactive protein levels (P?<?0.01 for both).ConclusionsSaxagliptin and metformin were comparably effective in regulating weight loss, glycemic control, and ?-cell function, improving lipid profiles, and reducing inflammation in newly diagnosed type 2 diabetes mellitus patients with polycystic ovary syndrome.Trial registrationChiCTR-IPR-17011120 (retrospectively registered on 2017-04-12).

Project description:BACKGROUND:This study aim at evaluating the efficacy and safety of dapagliflozin plus saxagliptin vs monotherapy as added to metformin in patients with type 2 diabetes mellitus (T2DM). METHOD:PubMed, Cochrane library, Embase, CNKI and Wanfang databases were searched up to 31 December 2019. Randomized controlled trials (RCTs) applicable in dapagliflozin plus saxagliptin vs monotherapy as added to metformin in the treatment of T2DM were included. The outcomes included changes in HbA1c, FPG, body weight, SBP, DBP and adverse reactions. Fixed or random effects model were used to assess these outcomes. RESULTS:In this study, 8 RCTs involved 7346 patients were included. Compared with dapagliflozin plus metformin(DM) group, patients treated with dapagliflozin plus saxagliptin add on to metformin(DSM) could significantly increase the adjusted mean change levels of HbA1c, FPG, SBP and DBP(P?<?.00001, SMD?=?-4.88, 95%CI?=?-6.93?-2.83; P?<?.00001, SMD?=?-6.50, 95%CI?=?-8.55?-4.45; P?<?.00001, SMD?=?-0.97, 95%CI?=?-1.15?-0.78; P?<?.00001, SMD?=?-2.00, 95%CI?=?-2.20?-1.80), but no major difference in body weight loss showed(P?=?.12, SMD?=?0.92, 95%CI?=?-0.22?2.06). Furthermore, DSM therapy displayed better effects than saxagliptin plus metformin(SM) in the adjusted mean change levels of HbA1c, FPG, body weight and SBP(P?<?.00001, SMD?=?-7.75, 95%CI?=?-8.84?-6.66; P?<?.00001, SMD?=?-7.75, 95%CI?=?-8.84?-6.66; P?=?.04, SMD?=?-3.40, 95%CI?=?-6.64?-0.17; P?=?.04, SMD?=?-7.75, 95%CI?=?-8.84?-6.66), whereas no obvious difference in lowering DBP(P?=?.18, SMD?=?-16.35, 95%CI?=?-40.12?7.41). Additionally, compared with DM and SM groups, there were no remarkable difference in the incidence of nausea, influenza, headache, diarrhea, urinary tract infection and renal failure for patients taking DSM, but the incidence of genital infection and hypoglycemia were higher in DSM group. CONCLUSIONS:Patients taking the DSM therapy had better effects in reducing the level of HbA1c, FPG, body weight, SBP and DBP than the DM and SM therapy. However, patients treated with DSM therapy are more likely to have hypoglycemia and genital infection. Dapagliflozin plus saxagliptin may be a suitable therapy strategy for patients with T2DM inadequately controlled with metformin, and this will provide a clinical reference for the treatment of T2DM.

Dataset Information

A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy.

Publications

A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy.

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