Patient considerations and clinical utility of a fixed dose combination of saxagliptin/metformin in the treatment of type 2 diabetes

Figures & data

Table 1 DPP-4 agonists: dosage and use

Drug	Dosage	Use
Sitagliptin	100 mg once daily	As an adjunct to diet and exercise to improve glycemic control as an add-on therapy to: metformin (dual therapy) sulfonylurea (dual therapy) pioglitazone (dual therapy) sulfonylurea plus metformin (triple therapy) pioglitazone plus metformin (triple therapy) In the US as monotherapy; in the EU as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance Insulin (with or without metformin)
Vildagliptin	50 mg twice daily	As an adjunct to diet and exercise to improve glycemic control as an add-on therapy to: metformin (dual therapy) sulfonylurea (dual therapy): in that case vildagliptin should be used at the dosage of 50 mg/day pioglitazone (dual therapy)
Saxagliptin	5 mg once daily	As an adjunct to diet and exercise to improve glycemic control as an add-on therapy to: metformin (dual therapy) sulfonylurea (dual therapy) pioglitazone (dual therapy)

Table 2 summary of the studies included in the review

Study	Duration	Drugs involved	Baseline population	Results
Pfützner et al^Citation20,Citation21	76 weeks	saxagliptin/metformin 5/500 mg saxagliptin/metformin 10/500 mg saxagliptin 10 g/placebo metformin 500 mg/placebo.	1306 patients, 18–77 years of age with HbA1c 8.0%–12.0%.	HbA1c : −2.31% for saxagliptin/metformin 5/500 mg* −2.33% for saxagliptin/metformin 10/500 mg* −1.55% for saxagliptin 10 mg −1.79% for metformin 500 mg (*P < 0.0001 versus metformin and saxagliptin monotherapies)
Scheen et al^Citation22	18 weeks	saxagliptin 5 mg once daily as add on therapy to previously taken metformin sitagliptin 100 mg once daily as add-on therapy to previously taken metformin.	801 patients with HbA1c between 6.5%–10% on stable metformin doses (1500–3000 mg/day).	HbA1c: −0.52% for saxagliptin/metformin −0.62% for sitagliptin/metformin (P not significant)
De Fronzo et al^Citation23	24 weeks	saxagliptin 2.5 mg once daily as add on therapy to previously taken metformin saxagliptin 5 mg once daily as add on therapy to previously taken metformin saxagliptin 10 mg once daily as add on therapy to previously taken metformin placebo as add on therapy to previously taken metformin.	743 patients taking a stable dose of metformin (1.500 but not >2.550 mg/day)	HbA1c : −0.59% for saxagliptin 2.5 mg/metformin* −0.69% for saxagliptin 5 mg/metformin* −0.58% for saxagliptin 10 mg/metformin* +0.13% for placebo/metformin (*P ≤ 0.0001 versus placebo)
Goke et al^Citation24	52 weeks	saxagliptin 5 mg once daily as add on therapy to previously taken metformin glipizide up-titrated as needed from 5 to 20 mg/day as add on therapy to previously taken metformin.	858 patients on stable metformin doses ≥1500 mg/day	HbA1c : −0.74% for saxagliptin/metformin −0.80% for glipizide/metformin (P not significant) Hypoglycemia: 3% for saxagliptin/metformin* 36.3% for glipizide/metformin (*P < 0.0001 versus glipizide/metformin) Body weight: −1.1 kg for saxagliptin/metformin* +1.1 kg for with glipizide/metformin (*P < 0.0001 versus glipizide/metformin)

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DeFronzo RA Hissa MN Garber AJ for 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 9 1649 1655 19478198

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