Diabetes Metab J > Volume 46(1); 2022 > Article |
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CONFLICTS OF INTEREST
Bok Jin Hyun and Ji Eun Cha are employees of Handok Inc. The other authors declare that they have no competing interests.
AUTHOR CONTRIBUTIONS
Conception or design: J.C.B., S.H.K., H.J.K., S.Y.K., Y.C.H., S.S., B.J.H., J.E.C., J.C.W., J.H.K.
Acquisition, analysis, or interpretation of data: J.C.B., S.H.K., H.J.K., S.Y.K., Y.C.H., S.S., J.C.W., J.H.K.
Drafting the work or revising: J.C.B., S.H.K., H.J.K., J.C.W., J.H.K.
Final approval of the manuscript: J.C.B., S.H.K., H.J.K., S.Y.K., Y.C.H., S.S., B.J.H., J.E.C., J.C.W., J.H.K.
FUNDING
This study was funded by Handok Inc. (Seoul, Korea). The sponsor and all authors agreed on the study design, protocol, and statistical plan. An independent clinical research organization was responsible for trial management and data collection, and all statistical analyses were done by an independent data management team (LSK Global PS, Seoul, Korea). The sponsor had no role in data interpretation or manuscript writing.
Full analysis set | Teneligliptin (n=34) | Placebo (n=30) | P value |
---|---|---|---|
Age, yr | 70.3±4.4 | 70.5±3.8 | 0.694a |
≥70 | 16 (47.1) | 16 (53.3) | 0.704b |
Male sex | 23 (67.7) | 20 (67.7) | 0.934b |
Body mass index, kg/m2 | 25.5±3.5 | 24.5±2.6 | 0.181c |
Duration of diabetes, mo | 39.7 (0.2-391.7) | 30.6 (0.2-270.9) | 0.845a |
Diagnosed at ≥65 years | 23 (67.7) | 21 (70.0) | 0.839b |
Drug-naïve | 11 (32.3) | 9 (30.0) | 0.839b |
HbA1c, % | 7.5±0.5 | 7.5±0.5 | 0.627a |
<7.5 | 21 (61.8) | 18 (60.0) | 0.885b |
Fasting glucose, mg/dL | 135.9±21.3 | 143.0±26.5 | 0.237c |
Parameter | Teneligliptin (n=34) | Placebo (n=30) | Between-group difference (95% CI) | P value |
---|---|---|---|---|
Valid CGM data, day | ||||
Baseline | 4.7±0.9 | 4.6±1.0 | 0.954a | |
Week 12 | 4.5±1.1 | 4.3±1.0 | 0.707a | |
Mean glucose, mg/dL | ||||
Baselinea | 169.1±26.6 | 180.2±34.6 | ||
Change from baselineb | -25.9±4.0 | -6.8±4.2 | -19.1(-29.7 to -8.6) | 0.001c |
CV, % | ||||
Baselinea | 26.1±6.7 | 25.9±4.9 | ||
Change from baselineb | -5.1±1.1 | -0.5±1.2 | -4.6 (-7.3 to -1.9) | 0.001c |
SD, mg/dL | ||||
Baselinea | 44.1±13.1 | 46.3±10.9 | ||
Change from baselineb | -12.7±1.8 | -0.2±1.9 | -12.5 (-17.6 to -7.4) | <0.001c |
MAGE, mg/dL | ||||
Baselinea | 107.3±34.1 | 111.0±25.8 | ||
Change from baselineb | -32.0±4.9 | -4.5±5.1 | -27.5 (-39.4 to -15.5) | <0.001c |
TIR70-180 mg/dL, % | ||||
Baselinea | 62.7±20.9 | 55.0±22.7 | ||
Change from baselineb | 19.9±2.8 | 6.6±2.9 | 13.3 (6.0 to 20.6) | 0.001c |
TAR>250 mg/dL, % | ||||
Baselinea | 7.3±8.5 | 11.5±14.2 | ||
Change from baselineb | -6.7±1.5 | -1.0±1.5 | -5.7 (-9.5 to -1.9) | 0.004c |
TAR>180 mg/dL, % | ||||
Baselinea | 33.8±20.0 | 41.6±22.7 | ||
Change from baselineb | -19.5±2.6 | -7.0±2.7 | -12.4 (-19.2 to -5.6) | 0.001c |
TBR<70 mg/dL, % | ||||
Baselinea | 0.2±0.9 | 0.2±0.6 | ||
Change from baselineb | -0.1±0.2 | 0.2±0.3 | -0.3 (-0.9 to 0.4) | 0.383c |
TBR<54 mg/dL, % | ||||
Baselinea | 0.1±0.3 | 0.0±0.1 | ||
Change from baselineb | -0.1±0.4 | 0.2±1.3 | -0.3 (-0.8 to 0.2) | 0.199c |
Values are presented as mean±standard deviation or least-squares mean±standard error.
CGM, continuous glucose monitoring; CI, confidence interval; CV, coefficient of variation; SD, standard deviation; MAGE, mean amplitude of glycemic excursion; TIR, time in target glucose range; TAR, time above target glucose range; TBR, time below target glucose range.
Ji Cheol Bae
https://orcid.org/0000-0002-4763-5797
Soo Heon Kwak
https://orcid.org/0000-0003-1230-0919
Hyun Jin Kim
https://orcid.org/0000-0002-6760-4963
Jong Chul Won
https://orcid.org/0000-0002-2219-4083
Jae Hyeon Kim
https://orcid.org/0000-0001-5001-963X
Handok Inc