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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Youngene Therapeutics Inc., Ltd.
Study ID
NCT04956263
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • YG1699 — DRUG
    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.
  • Dapagliflozin — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 17, 2021
Status verified
Jul 2022
Primary completion
Feb 2, 2022
Completion
Jul 19, 2022

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    YG1699 10 mg
  • Experimental: Treatment B
    YG1699 25 mg
  • Active Comparator: Treatment C
    Dapagliflozin 10 mg

Primary Outcome Measure

Concentration-time curve in plasma glucose (AUC(0-120min) ) [ Time Frame: 6th day of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
ProSciento, IncChula VistaCalifornia91911-

Find similar trials in Chula Vista, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
ProSciento, Inc· Chula Vista, CA

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