A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title: A Comparison of Postprandial Glucose After a Mixed Meal Tolerance Test, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study of the Dual Systemic SGLT1 and SGLT2 Inhibitor YG1699, and the Selective SGLT2 Inhibitor Dapagliflozin in Subjects With Type 1 Diabetes

Status Completed

Clinical Trial Summary

This is an inpatient treatment, double-blind, randomized, 3-way crossover study in T1DM subjects using insulin pump therapy.

Clinical Trial Description

Subjects will be randomized to one of 6 treatment sequences. The randomized study drug will be administered once daily for 7 days throughout each of 3 treatment periods. Each subject will attend an in-house baseline period, the NoTreatment period, and 3 in-house treatment periods, The Active Periods, where the same assessments will be performed. At each of the in-house periods, a MMTT will be carried out on the sixth day of dosing and an insulin withdrawal test will be carried out on the seventh day of dosing. Postprandial glycemic excursion after a MMTT will be evaluated one day prior to an insulin withdrawal test. An insulin pumps with different modes (such as open loop/closed loop) the mode used at screening will be the mode used throughout the study. Unblinded continuous glucose monitoring (CGM) will be initiated at the start of the 7-day Baseline Period (Day -7) and discontinued at End of Treatment (Day 34). ;

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

• NCT number: NCT04956263
• Study type: Interventional
• Source: Youngene Therapeutics Inc., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2021
• Completion date: July 19, 2022