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
Condition: Diabetes; Diabetes Mellitus, Type 1; Type1diabetes; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

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

Detailed 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).
    

Intervention name(s): YG1699; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM.
The proposed dosage form is a yellow, film-coated tablet for oral administration. The proposed tablet strengths for the current clinical research are 5 mg and 25 mg. The tablets are packaged in high-density polyethylene (HDPE) bottles with HDPE caps and desiccant inserters. Each HDPE bottle contains 30 tablets of drug product.
The study drug YG1699 is manufactured by Youngene Therapeutics Inc., Ltd., China.; Farxiga® is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Faxiga® is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.
Other intervention name(s): Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: During the No Treatment Period prior to the baseline MMTT performed on Day -2, subjects will be randomized 1:1:1:1:1:1 to one of six Treatment Sequences A/B/C, A/C/B, B/C/A, B/A/C, C/B/A or C/A/B:
Treatment A is YG1699 10 mg
Treatment B is YG1699 25 mg
Treatment C is dapagliflozin 10 mg
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mixed Meal Tolerance Test; Insulin Withdrawal