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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

NCT04956263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-07-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

YG1699

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.

DRUG

Dapagliflozin

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.

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • Youngene Therapeutics Inc., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2022-02-02
Completion
2022-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956263 on ClinicalTrials.gov