Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study)

Abstract

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.

Keywords: Aged; Blood glucose self-monitoring; Diabetes mellitus, type 2; Dipeptidyl peptidase 4; Glycated hemoglobin A.

Conflict of interest statement

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.

Figures

Fig. 1.

Trial profile. aThe full analysis set consisted of all participants who received at least one dose of the trial medication and for whom primary efficacy endpoints were measured at week 12 after randomization.

Fig. 2.

Percentage of time spent in glycemic ranges of 180, and >250 mg/dL among participants monitored with continuous glucose monitoring. Data are presented as mean. aIncludes percentage of values >250 mg/dL, bIncludes percentage of values <54 mg/dL. The percentage of values <70 mg/dL was less than 0.3%.

Fig. 3.

Ambulatory glucose profiles at baseline and week 12. (A) Teneligliptin group at baseline. (B) Teneligliptin group at week 12. (C) Placebo group at baseline. (D) Placebo group at week 12. Median (50%) and other percentiles are shown for a single day in each treatment group.

Fig. 4.

(A) Glycosylated hemoglobin (HbA1c) level over time (mean±standard error [SE]). (B) Least squares mean (LS mean) change from baseline in the HbA1c level at week 12. (C) LS mean change from baseline in fasting plasma glucose (FPG) at week 12. (D) Proportion of participants achieving the target HbA1c. The error bars show the mean±SE. aBy analysis of covariance (ANCOVA) with baseline values and stratification factors (at randomization) as covariates, bLS mean difference (95% confidence interval), cBy chi-square test with baseline values and stratification factors (at randomization) as covariates.