Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study)
Background To evaluate the effects of teneligliptin on glycosylated hemoglobin (HbA1c) levels, continuous glucose monitoring (CGM)-derived time in range, and glycemic variability in elderly type 2 diabetes mellitus patients. Methods This randomized, double-blinded, placebo-controlled study was condu...
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| Language: | English |
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Korean Diabetes Association
2022-01-01
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| Series: | Diabetes & Metabolism Journal |
| Subjects: | |
| Online Access: | http://www.e-dmj.org/upload/pdf/dmj-2021-0016.pdf |
| _version_ | 1819291597614874624 |
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| author | Ji Cheol Bae Soo Heon Kwak Hyun Jin Kim Sang-Yong Kim You-Cheol Hwang Sunghwan Suh Bok Jin Hyun Ji Eun Cha Jong Chul Won Jae Hyeon Kim |
| author_facet | Ji Cheol Bae Soo Heon Kwak Hyun Jin Kim Sang-Yong Kim You-Cheol Hwang Sunghwan Suh Bok Jin Hyun Ji Eun Cha Jong Chul Won Jae Hyeon Kim |
| author_sort | Ji Cheol Bae |
| collection | DOAJ |
| description | Background To evaluate the effects of teneligliptin on glycosylated hemoglobin (HbA1c) levels, continuous glucose monitoring (CGM)-derived time in range, and glycemic variability in elderly type 2 diabetes mellitus patients. Methods This randomized, double-blinded, placebo-controlled study was conducted in eight centers in Korea (clinical trial registration number: NCT03508323). Sixty-five participants aged ≥65 years, who were treatment-naïve or had been treated with stable doses of metformin, were randomized at a 1:1 ratio to receive 20 mg of teneligliptin (n=35) or placebo (n=30) for 12 weeks. The main endpoints were the changes in HbA1c levels from baseline to week 12, CGM metrics-derived time in range, and glycemic variability. Results After 12 weeks, a significant reduction (by 0.84%) in HbA1c levels was observed in the teneligliptin group compared to that in the placebo group (by 0.08%), with a between-group least squares mean difference of –0.76% (95% confidence interval [CI], –1.08 to –0.44). The coefficient of variation, standard deviation, and mean amplitude of glycemic excursion significantly decreased in participants treated with teneligliptin as compared to those in the placebo group. Teneligliptin treatment significantly decreased the time spent above 180 or 250 mg/dL, respectively, without increasing the time spent below 70 mg/dL. The mean percentage of time for which glucose levels remained in the 70 to 180 mg/dL time in range (TIR70–180) at week 12 was 82.0%±16.0% in the teneligliptin group, and placebo-adjusted change in TIR70–180 from baseline was 13.3% (95% CI, 6.0 to 20.6). Conclusion Teneligliptin effectively reduced HbA1c levels, time spent above the target range, and glycemic variability, without increasing hypoglycemia in our study population. |
| first_indexed | 2024-12-24T03:41:10Z |
| format | Article |
| id | doaj.art-6bf63be2669f4978a706901651817f65 |
| institution | Directory Open Access Journal |
| issn | 2233-6079 2233-6087 |
| language | English |
| last_indexed | 2024-12-24T03:41:10Z |
| publishDate | 2022-01-01 |
| publisher | Korean Diabetes Association |
| record_format | Article |
| series | Diabetes & Metabolism Journal |
| spelling | doaj.art-6bf63be2669f4978a706901651817f652022-12-21T17:16:53ZengKorean Diabetes AssociationDiabetes & Metabolism Journal2233-60792233-60872022-01-01461819210.4093/dmj.2021.00162559Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study)Ji Cheol Bae0Soo Heon Kwak1Hyun Jin Kim2Sang-Yong Kim3You-Cheol Hwang4Sunghwan Suh5Bok Jin Hyun6Ji Eun Cha7Jong Chul Won8Jae Hyeon Kim9 Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Chosun University College of Medicine, Gwangju, Korea Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Dong-A University Medical Center, Dong-A University College of Medicine, Busan, Korea Handok Inc., Seoul, Korea Handok Inc., Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, KoreaBackground To evaluate the effects of teneligliptin on glycosylated hemoglobin (HbA1c) levels, continuous glucose monitoring (CGM)-derived time in range, and glycemic variability in elderly type 2 diabetes mellitus patients. Methods This randomized, double-blinded, placebo-controlled study was conducted in eight centers in Korea (clinical trial registration number: NCT03508323). Sixty-five participants aged ≥65 years, who were treatment-naïve or had been treated with stable doses of metformin, were randomized at a 1:1 ratio to receive 20 mg of teneligliptin (n=35) or placebo (n=30) for 12 weeks. The main endpoints were the changes in HbA1c levels from baseline to week 12, CGM metrics-derived time in range, and glycemic variability. Results After 12 weeks, a significant reduction (by 0.84%) in HbA1c levels was observed in the teneligliptin group compared to that in the placebo group (by 0.08%), with a between-group least squares mean difference of –0.76% (95% confidence interval [CI], –1.08 to –0.44). The coefficient of variation, standard deviation, and mean amplitude of glycemic excursion significantly decreased in participants treated with teneligliptin as compared to those in the placebo group. Teneligliptin treatment significantly decreased the time spent above 180 or 250 mg/dL, respectively, without increasing the time spent below 70 mg/dL. The mean percentage of time for which glucose levels remained in the 70 to 180 mg/dL time in range (TIR70–180) at week 12 was 82.0%±16.0% in the teneligliptin group, and placebo-adjusted change in TIR70–180 from baseline was 13.3% (95% CI, 6.0 to 20.6). Conclusion Teneligliptin effectively reduced HbA1c levels, time spent above the target range, and glycemic variability, without increasing hypoglycemia in our study population.http://www.e-dmj.org/upload/pdf/dmj-2021-0016.pdfagedblood glucose self-monitoringdiabetes mellitus, type 2dipeptidyl peptidase 4glycated hemoglobin a |
| spellingShingle | Ji Cheol Bae Soo Heon Kwak Hyun Jin Kim Sang-Yong Kim You-Cheol Hwang Sunghwan Suh Bok Jin Hyun Ji Eun Cha Jong Chul Won Jae Hyeon Kim Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) Diabetes & Metabolism Journal aged blood glucose self-monitoring diabetes mellitus, type 2 dipeptidyl peptidase 4 glycated hemoglobin a |
| title | Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) |
| title_full | Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) |
| title_fullStr | Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) |
| title_full_unstemmed | Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) |
| title_short | Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study) |
| title_sort | effects of teneligliptin on hba1c levels continuous glucose monitoring derived time in range and glycemic variability in elderly patients with t2dm teddy study |
| topic | aged blood glucose self-monitoring diabetes mellitus, type 2 dipeptidyl peptidase 4 glycated hemoglobin a |
| url | http://www.e-dmj.org/upload/pdf/dmj-2021-0016.pdf |
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