Despite increasing prevalence of T2D in older Chinese people, no studies have evaluated the efficacy and safety of DPP-4 inhibitor-based combination therapy in this population. In the STRATEGY Study (a multicenter, randomized, active-controlled, open-label clinical trial in Chinese people with T2D), patients were treated for 20 weeks with a combination of SITA and metformin (MET) (Phase 1). Those with A1C ≥7.0% and ≤10.0% at Week 16 were randomly assigned at Week 20 to 1 of 4 additional AHAs and continued treatment for another 24 weeks (Phase 2). Here we report efficacy and safety in the 681 patients aged ≥65 year.
At baseline, the mean age, duration of diabetes, BMI and A1C of the analysis population were 68.4 year, 7.5 year, 25 kg/m2 and 7.7%, respectively; ≈half were male. Changes in A1C are shown in the Table. Achievement of A1C goal of <7% was observed in 44.9% (305/680) during Phase 1, and 65.4% (445/680) during Phases 1 + 2.
Through Week 20/n=681 and Week 44/n=269, the incidences of any adverse events (AEs) were 30% and 31%, of drug-related AEs were 4% and 5%, and of serious AEs were 2% and 3%, respectively. Hypoglycemia incidences were highest with glimepiride and gliclazide (Table); no severe hypoglycemia was reported.
In older Chinese people, dual and triple combination therapy based on SITA and MET provided clinically meaningful improvement in glycemic control and was generally well tolerated.
| Phase 1 (Baseline through Week 20) | |||
| Baseline A1C, mean ± SD, % | Change from baseline A1C at Week 16, % | Hypoglycemia, % (n/N) (APaT Population) | |
| SITA + MET, N = 626 | 7.94 ± 0.78 | -0.81 ± 0.82 | 4.3% (29/681) |
| Phase 2 (Weeks 20 through 44) | |||
| Week 20 A1C, mean ± SD, % | Change from Week 20 A1C at Week 44, % | Hypoglycemia, % (n/n) (APaT Population) | |
| SITA + MET + glimepiride, n = 63 | 7.62 ± 0.82 | -0.73 ± 0.87 | 9.6% (7/73) |
| SITA + MET + gliclazide, n = 69 | 7.68 ± 0.76 | -0.65 ± 0.77 | 10.5% (8/76) |
| SITA + MET + repaglinide, n = 47 | 7.69 ± 0.70 | -0.54 ± 0.78 | 5.9% (3/51) |
| SITA + MET + acarbose, n = 64 | 7.59 ± 0.69 | -0.46 ± 0.73 | 1.5% (1/69) |
| Phase 1 (Baseline through Week 20) | |||
| Baseline A1C, mean ± SD, % | Change from baseline A1C at Week 16, % | Hypoglycemia, % (n/N) (APaT Population) | |
| SITA + MET, N = 626 | 7.94 ± 0.78 | -0.81 ± 0.82 | 4.3% (29/681) |
| Phase 2 (Weeks 20 through 44) | |||
| Week 20 A1C, mean ± SD, % | Change from Week 20 A1C at Week 44, % | Hypoglycemia, % (n/n) (APaT Population) | |
| SITA + MET + glimepiride, n = 63 | 7.62 ± 0.82 | -0.73 ± 0.87 | 9.6% (7/73) |
| SITA + MET + gliclazide, n = 69 | 7.68 ± 0.76 | -0.65 ± 0.77 | 10.5% (8/76) |
| SITA + MET + repaglinide, n = 47 | 7.69 ± 0.70 | -0.54 ± 0.78 | 5.9% (3/51) |
| SITA + MET + acarbose, n = 64 | 7.59 ± 0.69 | -0.46 ± 0.73 | 1.5% (1/69) |
X. Liu: None. L. Wang: None. Y. Xing: None. S.S. Engel: Employee; Self; Merck & Co., Inc.. Stock/Shareholder; Self; Merck & Co., Inc. G. Chen: Employee; Self; Merck Sharp & Dohme Corp.. Y. Zhang: None. R. Zhang: Employee; Self; Merck Sharp & Dohme Corp.. S. Liu: None. J. Weng: None. Q. Ji: Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Consultant; Self; Sanofi-Aventis. Speaker's Bureau; Self; Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company, Medtronic. Research Support; Self; Merck & Co., Inc., Merck & Co., Inc..
