Tenelia Elderly CGMS Study(TEDDY)

Phase 4 Completed 65 enrolled Handok Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy and safety of Teneligliptin in Patients aged 65 and Older with inadequately controlled type 2 diabetes.

Timeline

Start: 2018-04-03
Primary completion: 2019-12-12
Completion: 2019-12-12

Outcome

Met primary endpoint

paper 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 PMID 34130378 ↗

paper placebo-adjusted change in TIR70-180 from baseline was 13.3% (95% CI, 6.0 to 20.6). PMID 34130378 ↗

paper 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. PMID 34130378 ↗

Publications

Bae JC, Kwak SH, Kim HJ, Kim SY, Hwang YC, Suh S, Hyun BJ, Cha JE, Won JC, Kim JH. Effects of Teneligliptin on HbA1c levels, Continuous Glucose Monitoring-Derived Time in Range and Glycemic Variability in Elderly Patients with T2DM (TEDDY Study). Diabetes Metab J. 2022 Jan;46(1):81-92. doi: 10.4093/dmj.2021.0016. Epub 2021 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Teneligliptin	Small molecule	20 mg	—