Fixed-dose combination of sitagliptin and metformin for the treatment of type 2 diabetes

Figures & data

Table 1 Glycosylated hemoglobin (A1C) endpoints for the treatment arms studied by Goldstein and colleagues²⁸

Treatment arm	n	A1C at baseline	A1C at week 24	Change in A1C (%) from baseline to week 24
Metformin/sitagliptin 1,000 mg/50 mg bid	178	8.76% ± 0.95%	6.87% ± 1.09%	−1.90% (−2.06% to − 1.74%)
Metformin/sitagliptin 500 mg/50 mg bid	183	8.79% ± 1%	7.37% ± 1.20%	−1.40% (−1.56% to −1.24%)
Metformin 1,000 mg bid	177	8.68% ± 0.91%	7.58% ± 1.27%	−1.13% (− 1.29% to −0.97%)
Metformin 500 mg bid	178	8.90% ± 1%	8.04% ± 1.36%	−0.82% (−0.98% to −0.66%)
Sitagliptin 100 mg qd	175	8.87% ± 0.99%	8.18% ± 1.45%	−0.66% (−0.83 to −0.50%)
Placebo	165	8.68% ± 1%	8.88% ± 1.47%	0.17% (±0.00–0.33)

Table 2 Key features and conclusions of trials that added sitagliptin to patients with type 2 diabetes mellitus (T2DM) who were currently under poor control with metformin or other therapy for glycemic control

Study authors	Treatment arms	N	Conclusions
Hermansen et al^Citation27	Placebo + glimepiride Placebo + glimepiride + metformin Sitagliptin + glimepiride Sitagliptin + glimepiride + metformin	Completed N = 87 Completed N = 92 Completed N = 83 Completed N = 102	The addition of sitagliptin 100 mg qd significantly improved glycemic control in patients who were inadequately controlled with glimepiride or glimepiride + metformin
Nauck et al^Citation24	Sitagliptin + metformin Glipizide + metformin	Completed N = 386 Completed N = 412	The addition of sitagliptin compared with glipizide provided similar A1C lowering efficacy over 52 weeks in patients on ongoing metformin therapy
Charbonnel et al^Citation25	Sitagliptin + metformin Placebo + metformin	N = 464 N = 237	Sitagliptin 100 mg qd added to ongoing metformin therapy was efficacious and well tolerated in patients with T2DM who were inadequately controlled on metformin alone
Brazg et al^Citation26	Placebo/sitagliptin 50 mg bid + metformin Sitagliptin 50 mg bid/placebo + metformin	N = 13 N = 15	Addition of sitagliptin 50 mg b.i.d. to ongoing metformin therapy was well tolerated and improved glycemic control and β-cell function
Raz et al^Citation30	Placebo Sitagliptin 100 mg qd Sitagliptin 200 mg qd	N = 110 N = 205 N = 206	Sitagliptin was well tolerated and significantly improved glycemic control in patients with T2DM who were inadequately controlled on exercise and diet. Sitagliptin 100 mg qd had a slight numerical benefit over sitagliptin 200 mg qd
Scott et al^Citation29	Placebo + metformin Sitagliptin 100 mg qd + metformin Rosiglitazone 8 mg qd + metformin	N = 92 N = 94 N = 87	Addition of sitagliptin was effective and well tolerated in T2DM patients who were inadequately controlled on metformin therapy alone. Treatment with sitagliptin and rosiglitazone produced similar reductions in A1C
Aschner et al^Citation21	Placebo Sitagliptin 100 mg qd. Sitagliptin 200 mg qd	N = 253 N = 238 N = 250	Once daily sitagliptin monotherapy was well tolerated improved glycemic control in the fasting and postprandial states and improved measures of β-cell function. Sitagliptin 200 mg qd was slightly favored over sitagliptin 100 mg qd

Abbreviations: bid, twice daily; qd, once daily.

Table 3 Endpoints for the treatment arms studied by Vanderpoel and colleagues⁴⁴

Therapy	n	Medication possession ratios pre-index	Medication possession ratios post-index
Remained on monotherapy throughout study	N = 14291	0.90	0.89
Switched to free-dose combination therapy after index date	N = 931	0.80	0.67
Switched to a fixed-dose combination after index date	N = 349	0.87	0.83
Remained on free-dose combination therapy after index date	N = 1,230	0.84	0.83
Switched the fixed-dose combination therapy after index date	N = 127	0.79	0.82

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