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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 | Clinical Trials | Clareo Health

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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

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

NCT04956263•Youngene Therapeutics Inc., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects ≥ 18 to ≤ 60 years of age at the time of signing the informed consent.
•2. Subjects diagnosed with T1DM for ≥ 12 months.
•3. Subjects who are currently using an approved insulin pump, with a stable basal insulin dose. Stable is defined as \< 20% change of dose during the last 2 weeks prior to Screening.
•4. HbA1c \< 9.5%.
•5. C-peptide after carbohydrate ingestion of \< 0.3 nmol/L, with simultaneous plasma glucose \> 90 mg/dL. (If necessary, subjects may consume carbohydrates to raise blood glucose over 90 mg/dL as measured by YSI prior to drawing blood for C-peptide. This may be repeated as needed to ensure C-peptide is assessed when plasma glucose concentration is \> 90 mg/dL).
•6. Fasting BOHB ≤ 0.6 mmol/L.
•7. Body mass index (BMI) within the range ≥ 18.5 to ≤ 27.0 kg/m2.
•8. Female subjects must be non-pregnant and non-lactating.
•9. Females of childbearing potential must use highly effective contraceptive methods, stable at least 2 months prior to the screening. Male subjects must be surgically sterile, abstinent or if engaged in sexual relations of childbearing potential, the subject and his partner must be using acceptable methods of contraception.
•10. Capable of giving signed informed consent and willing to follow study procedures and commitment to the study duration

Exclusion Criteria

•1. Subject has a diagnosis of type 2 diabetes (T2DM).
•2. Subject who has acute proliferative retinopathy or maculopathy, requiring acute treatment within 3 months of Screening.
•3. Subject who has ≥ 3 Level 2 or ≥ 1 Level 3 hypoglycemic events, or hypoglycemic unawareness, or had a severe hypoglycemic event (Level 3) within 1 month prior to Screening.
•4. Subject who has had DKA or nonketotic hyperosmolar state within 1 month of Screening, OR ≥ 2 events of DKA or nonketotic hyperosmolar state within 6 months of Screening.
•5. Subject with uncontrolled hypertension, defined as persistent blood pressure (BP) systolic or diastolic \> 150/90 mmHg, or hypotension, defined as BP \< 90/60 mmHg. (Subjects BP may be re-checked per site SOP)
•6. Subject with any clinically significant active disease of the gastrointestinal system (peptic ulcers, severe GERD, gastroparesis, any malabsorption/motility disorders, or chronic constipation). severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy, as judged by the Investigator.
•7. Subject with history of heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, coronary artery bypass graft surgery, or angioplasty, unstable angina requiring medication, transient ischemic attack, cerebral infarct, or cerebral hemorrhage.
•8. Subject with presence of clinically significant ECG findings (eg, QTcF \> 450 msec for males, QTcF \> 470 msec for females, left bundle branch block \[LBBB\],cardiac arrythmia) at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject.
•9. Subject with history of renal disease or abnormal kidney function tests at Screening (eGFR \< 60 mL/min/1.73m2 as estimated using the CKD-EPI Creatinine equation).
•10. History of hereditary glucose-galactose malabsorption or primary renal glucosuria
+19 more criteria

Locations (1)

ProSciento, Inc

Chula Vista, California, United States

Key Dates

Start Date

June 17, 2021

Primary Completion Date

February 2, 2022

Completion Date

July 19, 2022

Last Updated

July 28, 2022

Enrollment

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 1Type1diabetesDiabetes Mellitus

Interventions

YG1699

DRUG

Dapagliflozin

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

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