Clinical utility of fixed combinations of sitagliptin–metformin in treatment of type 2 diabetes

Figures & data

Table 1 Efficacy trials of sitagliptin–metformin combination therapy

Author	Subjects (n)	Mean age gender, race	Baseline mean HbA1C	Sitagliptin dose	Compared with	Add-on to	Trial duration	Mean HbA1C reduction	Change in body weight (kg)
Charbonnel et al^Citation28	701	Age 54y 58% male 65% White 14% Hispanic 11% Asian 6% Black 4% other	8.0%	100 mg daily	PBO	Metformin ≥1500 mg daily	24 weeks	PBO/M: 0.02% S/M: −0.67% HbA1C < 7.0%: PBO/M: 18.3% S/M: 47%	No difference between the groups
Goldstein et al^Citation29	1091	Age 54y 51% female 52% White 26% Hispanic 7% Black 6% Asian 9% other	8.8%	100 mg daily	S100/M2000 (S/M2), or S100/M1000 (S/M1), or M2000 (M2), or M1000 (M1), or S100 (S), or PBO	Diet and exercise	24 weeks	Change compared with PBO: S/M2: −2.07% S/M1: −1.57% M2: −1.30% M1: −0.99% S: −0.83% HbA1C < 7.0%: S/M2: 66% S/M1: 43% M2: 38% M1: 23% S: 20% PBO: 9%	−0.6 to −1.3 for all groups other than S [PBO −0.9]
Williams Herman et al^Citation30	885 of 1091	Age 54y 51% female 52% White 26% Hispanic 7% Black 6% Asian 9% other	8.6%	100 mg daily	S100/M2000 (S/M2), or S100/M1000 (S/M1), or M2000 (M2), or M1000 (M1), or S100 (S)	Diet and exercise	54 weeks (30 week continuation of Goldstein study)	LS mean change from baseline: (all subjects treated analysis) S/M2: −1.8% S/M1: −1.4% M2: −1.3% M1: −1.0% S: −0.8% HbA1C < 7.0%: S/M2: 67% S/M1: 48% M2: 44% M1: 25% S: 23%	−0.7 to −1.7 for all groups other than S
Raz et al^Citation31	190	55y 54% female 45% White 29% Hispanic 2% Black 23% multiracial	9.2%	100 mg daily	PBO	Metformin ≥1500 mg daily	30 weeks	PBO/M:0% S/M: −1.0% [Subjects with higher HbA1C tended to have greater reductions in HbA1C] HbA1C < 7%: 22.1% (S/M) +3.3% (PBO/M)	−0.5 in both groups
Nauck et al^Citation32	1172 (APT) cohort 793 (PP) cohort	56.7y 57% male 74% White 6.5% Black 7.6% Hispanic 8.5% Asian 3.5% other	7.7%	100 mg daily	APT cohort: Glipizide mean dose 10.6 mg daily PP cohort: Glipizide mean dose 10.3 mg daily	Metformin ≥1500 mg daily	52 weeks	APT cohort: S/M: −0.51% G/M: −0.56% PP cohort: −0.67% in both groups [Sitagliptin noninferior to glipizide] HbA1C < 7%: APT cohort: S/M: 52% G/M: 51% -PP cohort: S/M: 63% G/M: 59%	S/M: −1.5 G/M: +1.1
Scott et al^Citation33	273	55y 59% male 61% White 38% Asian 1% other	7.7%	100 mg daily	PBO or rosiglitazone 8 mg daily	Metformin ≥1500 mg daily	18 weeks	S/M: −0.73% R/M: −0.79% PBO/M: −0.22% [Sitagliptin noninferior to rosiglitazone] HbA1C < 7%: 55% (S/M) 63% (R/M) 38% (PBO/M)	PBO/M: −0.8 S/M: −0.4 R/M: +1.5
DeFronzo et al^Citation34	61	54y 54 female 30% White 8% Black 62% Hispanic	8.5%	100 mg daily	Exenatide 10 μg twice daily	Stable dose Metformin	2 weeks, with 2 week crossover	Mean 2-h PPG (ITT population): Exen/M: 166 mg/dL S/M: 210 mg/dL	Exen/M: −0.8 S/M: −0.3
Pratley et al^Citation35	665	55y 53% male 87% White 16% Hispanic 7% Black 2% Asian or Pacific Islander 4% other	8.4%	100 mg daily	Liraglutide 1.2 mg OR Liraglutide 1.8 mg	Metformin ≥1500 mg daily	26 weeks	Lira 1.2/M: −1.24% Lira 1.8/M: −1.5% S/M: −0.90%	Lira 1.2/M: −2.86 Lira 1.8/M: −3.38 S/M: −0.96

Abbreviations: HbA1c, glycosylated hemoglobin; PBO, placebo; S, sitagliptin; M, metformin; R, rosiglitazone; G, glipizide; Exen, exenatide; Lira, liraglutide; FPG, fasting plasma glucose; 2-h PPG, two-hour post prandial glucose; ITT, intention to treat; APT, all subjects treated; PP, per protocol.

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