Drug Interaction Study Between Dorzagliatin and Empagliflozin

NCT03790787 | Completed Phase 1 FDA Drug

• 1 other identifier: HMM0112
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.

Conditions

Patients

Outcome Measures

Primary Outcomes (8)

• GMR for Cmax of empagliflozin

  Geometric mean ratio (GMR) between combination and empagliflozin monotherapy for Cmax of empagliflozin

  up to 10 days

• GMR for AUC0-24h of empagliflozin

  GMR between combination and empagliflozin in monotherapy for AUC0-24h of empagliflozin

  up to 10 days

• GMR for Cmax of dorzagliatin

  GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin

  up to 15 days

• GMR for AUC0-24h of dorzagliatin

  GMR between combination and dorzagliatin in monotherapy for AUC0-24h of dorzagliatin

  up to 15 days

• Adverse events

  Number of participants with AEs

  up to 15 days

• Abnormal vital signs

  Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature)

  up to 15 days

• Abnormal clinical laboratory findings

  Number of participants with abnormal clinical laboratory findings

  up to 15 days

• 12-lead ECG

  Number of participants with abnormal ECG VR,, PR, QRS and QT

  up to 15 days

Secondary Outcomes (6)

• iCmax of glucose

  up to 15 days

• iAUC0-4h of glucose

  up to 15 days

• iCmax of insulin

  up to 15 days

• iAUC0-4h of insulin

  up to 15 days

• iCmax of C-peptide

  up to 15 days

Study Arms (1)

Sequential arm ABC

EXPERIMENTAL

A: Empagliflozin 25 mg QD in the morning on Days 1-5; B: Empagliflozin 25 mg in the morning and Dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15.

Drug: Empagliflozin; Drug: Dorzagliatin

Interventions

Empagliflozin DRUG

Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration

Also known as: Jardiance

Sequential arm ABC

Dorzagliatin DRUG

Glucokinase activator currently under development

Also known as: HMS5552

Sequential arm ABC

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with T2DM within at least 3 months prior to screening
• Male and/or female subjects between the ages of 30 and 65 years, inclusive;
• Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;
• Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
• HbA1c ≥7% and ≤10.5%;

You may not qualify if:

• Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
• Type 1 diabetes mellitus;
• Reported incidence of severe hypoglycemia within 3 months prior to screening;
• Known contraindications to empagliflozin;
• Clinically significant gastrointestinal disorder;
• History or symptoms of clinically significant cardiovascular disease;
• History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
• Reported history of clinically significant central nervous system disease including within one year prior to screening;
• Reported history of liver disease;
• Reported history of clinically significant renal disease;
• Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
• Known or suspected malignancy;
• Any reported hypersensitivity or intolerance to empagliflozin;
• Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;

Sponsors & Collaborators

• Hua Medicine Limited: lead

Study Sites (1)

Frontage Clinical Services Inc.

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

empagliflozin; Dorzagliatin

Study Officials

• Gregory J Tracey, MD

  Frontage Clinical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 2, 2019
• Study Start: April 18, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 24, 2025

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)