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Emerging Technologies and Therapeutics

Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes

  1. Wayne H.-H. Sheu1,
  2. Ira Gantz2⇑,
  3. Menghui Chen2,
  4. Shailaja Suryawanshi2,
  5. Arpana Mirza2,
  6. Barry J. Goldstein2,
  7. Keith D. Kaufman2 and
  8. Samuel S. Engel2
  1. 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan; and College of Medicine, National Defense Medical Center, Taipei, Taiwan
  2. 2Merck & Co., Inc., Kenilworth, NJ
  1. Corresponding author: Ira Gantz, ira.gantz{at}merck.com.
Diabetes Care 2015 Nov; 38(11): 2106-2114. https://doi.org/10.2337/dc15-0109
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    Figure 1

    Efficacy measures: HbA1c through week 12 (A); PMG change from baseline at week 12 (B); FPG through week 12 (C); HbA1c through week 78 (D). A and C: Gray circle, placebo; orange circle, omarigliptin 0.25 mg; green triangle, omarigliptin 1 mg; open triangle, omarigliptin 3 mg; orange square, omarigliptin 10 mg; blue square, omarigliptin 25 mg. D: Gray circle, placebo/metformin; orange circle, omarigliptin 0.25/25 mg; green triangle, omarigliptin 1/25 mg; open triangle, omarigliptin 3/25 mg; orange square, omarigliptin 10/25 mg; blue square, omarigliptin 25/25 mg. The LS estimates in A, B, and C are based on a model with terms for treatment, prior AHA therapy status (yes/no), geographic region (Japan/not Japan), and the interaction of time by treatment and time by prior AHA therapy status, with a constraint that the mean baseline is the same for all treatment groups. Note that the LS estimates in D are obtained from a model with the same terms without the constraint on the mean baseline because this analysis is based on a self-selected subset of randomized patients who entered the extension study.

Tables

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  • Table 1

    Baseline demographic and anthropomorphic characteristics of base study treatment groups

    ParameterPlacebo(n = 114)Omarigliptin once weekly
    0.25 mg(n = 113)1 mg(n = 115)3 mg(n = 114)10 mg(n = 115)25 mg(n = 114)
    Age, years55.9 ± 8.454.3 ± 8.955.7 ± 8.555.3 ± 8.554.4 ± 10.055.1 ± 8.8
    Male, %65 (57.0)65 (57.5)67 (58.3)65 (57.0)56 (48.7)69 (60.5)
    Race
     White64 (56.1)60 (53.1)70 (60.9)70 (61.4)64 (55.7)62 (54.4)
     Asian32 (28.1)33 (29.2)33 (28.7)27 (23.7)30 (26.1)30 (26.3)
     Multiracial10 (8.8)6 (5.3)4 (3.5)5 (4.4)8 (7.0)12 (10.5)
     American Indian or Alaska Native4 (3.5)8 (7.1)6 (5.2)2 (1.8)9 (7.8)3 (2.6)
     Black or African American3 (2.6)5 (4.4)2 (1.7)8 (7.0)3 (2.6)7 (6.1)
     Native Hawaiian or other Pacific Islander1 (0.9)1 (0.9)0 (0.0)2 (1.8)1 (0.9)0 (0.0)
    Ethnicity
     Hispanic or Latino34 (29.8)30 (26.5)35 (30.4)24 (21.1)31 (27.0)37 (32.5)
     Not Hispanic or Latino80 (70.2)83 (73.5)80 (69.6)90 (78.9)84 (73.0)77 (67.5)
    Body weight, kg82.1 ± 20.482.0 ± 18.882.5 ± 17.784.1 ± 17.282.3 ± 16.580.5 ± 17.5
    BMI, kg/m229.6 ± 5.329.7 ± 5.529.9 ± 5.330 ± 5.130.4 ± 5.229.2 ± 5.2
    Type 2 diabetes duration, years5.8 ± 4.64.8 ± 4.25.3 ± 4.35.4 ± 3.95.1 ± 4.65.9 ± 5.2
    Prior AHA use58 (50.9)59 (52.2)59 (51.3)59 (51.8)59 (51.3)59 (51.8)
    HbA1c, % 8.1 ± 0.98.1 ± 0.98.0 ± 0.97.9 ± 0.98.0 ± 0.98.1 ± 1.0
     Range6.6–10.46.0–11.36.0–10.46.7–11.76.4–10.76.4–11.0
    HbA1c, mmol/mol65.0 ± 9.865.2 ± 10.163.8 ± 9.463.2 ± 9.564.4 ± 9.465.5 ± 11.1
     Range48.6–90.242.1–100.042.1–90.249.7–104.4 46.4–93.446.4–96.7
    2-h PMG, mmol/L13.4 ± 4.012.7 ± 3.512.7 ± 3.613.0 ± 4.512.9 ± 4.013.6 ± 4.6
    FPG, mmol/L9.6 ± 2.49.5 ± 2.59.4 ± 2.49.4 ± 2.49.3 ± 2.19.7 ± 2.6
    • Data are expressed as mean ± SD or as n (%), unless otherwise indicated.

    • To convert PMG or FPG in mmol/L to mg/dL, multiply by 18.

  • Table 2

    Efficacy end points at week 12

    ParameterPlaceboOmarigliptin once weekly
    0.25 mg1 mg3 mg10 mg25 mg
    HbA1cn = 113n = 113n = 115n = 114n = 115n = 114
     Change from baseline
      HbA1c, % 0.14 (−0.01, 0.30)−0.14 (−0.30, 0.01)−0.36 (−0.51, −0.20)−0.35 (−0.50, −0.19)−0.53 (−0.68, −0.37)−0.57 (−0.73, −0.42)
      HbA1c, mmol/mol1.5 (−0.1, 3.2)−1.5 (−3.2, 0.2)−3.9 (−5.6, −2.2)−3.8 (−5.5, −2.1)−5.8 (−7.4, −4.1)−6.3 (−8.0, −4.6)
     Change vs. placebo
      HbA1c, % —−0.28 (−0.50, −0.06)§−0.50 (−0.71, −0.28)*−0.49 (−0.70, −0.27)*−0.67 (−0.88, −0.45)*−0.72 (−0.93, −0.50)*
      HbA1c, mmol/mol—−3.1 (−5.5, −0.7)−5.4 (−7.8, −3.1)−5.3 (−7.7, 2.9)−7.3 (−9.7, −4.9)−7.8 (−10.2, −5.4)
    2-h PMG, mmol/Ln = 111n = 112n = 113n = 114n = 114n = 112
     Change from baseline0.4 (−0.1, 1.0)−0.6 (−1.2, −0.1)−1.4 (−2.0, −0.9)−1.5 (−2.1, −1.0)−1.9 (−2.4, −1.4)−2.1 (−2.6, −1.5)
     Change vs. placebo—−1.0 (−1.8, −0.3)‡−1.8 (−2.6, −1.1)*−1.9 (−2.7, −1.2)*−2.3 (−3.1, −1.5)*−2.5 (−3.3, −1.7)*
    FPG, mmol/Ln = 113n = 113n = 115n = 114n = 115n = 114
     Change from baseline0.3 (−0.0, 0.6)0.1 (−0.2, 0.4)−0.8 (−1.1, −0.5)−0.6 (−0.9, −0.3)−0.5 (−0.9, −0.2)−1.0 (−1.3, −0.7)
     Change vs. placebo—−0.2 (−0.7, 0.2)†−1.1 (−1.6, −0.7)*−0.9 (−1.3, −0.5)*−0.9 (−1.3, −0.4)*−1.3 (−1.8, −0.9)*
    • Change from baseline is the LS mean change from baseline at week 12 (95% CI). Change vs. placebo is the between-treatment difference in the LS mean change from baseline at week 12 (95% CI). To convert PMG or FPG in mmol/L to mg/dL, multiply by 18.

    • ↵§P = 0.012 from trend test for omarigliptin vs. placebo.

    • ↵*P < 0.001 from trend test for omarigliptin vs. placebo.

    • ↵‡P = 0.009 from trend test for omarigliptin vs. placebo.

    • ↵†P = 0.276 from trend test for omarigliptin vs. placebo.

  • Table 3

    Efficacy end points at week 78

    ParameterPlacebo/metforminOmarigliptin once weekly
    0.25/25 mg1/25 mg3/25 mg10/25 mg25 mg
    HbA1cn = 80n = 83n = 91n = 79n = 82n = 70
     Baseline
      HbA1c, % 8.2 ± 0.98.1 ± 0.98.0 ± 0.97.9 ± 0.88.0 ± 0.98.0 ± 0.8
      HbA1c, mmol/mol65.7 ± 9.965.4 ± 9.964.1 ± 9.862.4 ± 8.864.4 ± 9.464.2 ± 9.3
     Change from baseline
      HbA1c, % −0.73 (−1.07, −0.40)−0.46 (−0.80, −0.13)−0.28 (−0.61, 0.06)−0.18 (−0.52, 0.17)−0.35 (−0.71, 0.01)−0.34 (−0.70, 0.03)
      HbA1c, mmol/mol−8.0 (−11.7, −4.3)−5.1 (−8.8, −1.4)−3.0 (−6.7, 0.7)−1.9 (−5.7, 1.9)−3.9 (−7.8, 0.1)−3.7 (−7.7, 0.3)
    2-h PMG, mmol/Ln = 79n = 83n = 91n = 79n = 82n = 70
     Baseline13.6 ± 3.913.0 ± 3.612.9 ± 3.612.6 ± 3.613.0 ± 4.313.3 ± 4.4
     Change from baseline−2.2 (−3.2, −1.3)−2.1 (−3.0, −1.1)−1.2 (−2.1, −0.2)−1.0 (−2.0, −0.0)−1.5 (−2.6, −0.5)−2.4 (−3.4, −1.4)
    FPG, mmol/Ln = 80n = 83n = 91n = 79n = 82n = 70
     Baseline9.6 ± 2.49.5 ± 2.39.5 ± 2.59.2 ± 1.99.2 ± 2.39.6 ± 2.6
     Change from baseline−0.6 (−1.5, 0.2)−0.2 (−1.1, 0.6)−0.2 (−1.0, 0.6)−0.0 (−0.9, 0.9)−0.2 (−1.1, 0.7)0.2 (−0.7, 1.1)
    • Baseline and week 78 data are presented as mean ± SD. Change from baseline is the LS mean change from baseline at week 78 (95% CI). To convert PMG or FPG in mmol/L to mg/dL, multiply by 18.

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Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes
Wayne H.-H. Sheu, Ira Gantz, Menghui Chen, Shailaja Suryawanshi, Arpana Mirza, Barry J. Goldstein, Keith D. Kaufman, Samuel S. Engel
Diabetes Care Nov 2015, 38 (11) 2106-2114; DOI: 10.2337/dc15-0109

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Safety and Efficacy of Omarigliptin (MK-3102), a Novel Once-Weekly DPP-4 Inhibitor for the Treatment of Patients With Type 2 Diabetes
Wayne H.-H. Sheu, Ira Gantz, Menghui Chen, Shailaja Suryawanshi, Arpana Mirza, Barry J. Goldstein, Keith D. Kaufman, Samuel S. Engel
Diabetes Care Nov 2015, 38 (11) 2106-2114; DOI: 10.2337/dc15-0109
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