Drug Interaction Study Between Dorzagliatin and Empagliflozin

March 20, 2025 updated by: Hua Medicine Limited

A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Empagliflozin in Subjects with Type 2 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Frontage Clinical Services Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
  2. Type 1 diabetes mellitus;
  3. Reported incidence of severe hypoglycemia within 3 months prior to screening;
  4. Known contraindications to empagliflozin;
  5. Clinically significant gastrointestinal disorder;
  6. History or symptoms of clinically significant cardiovascular disease;
  7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
  8. Reported history of clinically significant central nervous system disease including within one year prior to screening;
  9. Reported history of liver disease;
  10. Reported history of clinically significant renal disease;
  11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
  12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  13. Known or suspected malignancy;
  14. Any reported hypersensitivity or intolerance to empagliflozin;
  15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
  16. Systolic blood pressure <90 or >160 mmHg or diastolic blood pressure <60 or >100 mmHg at screening;
  17. A hospital admission or major surgery within 90 days prior to screening;
  18. Uncontrolled hypertriglyceridemia >500 mg/dL;
  19. Positive blood screen for HIV, HBsAg, or hepatitis C antibody;
  20. Positive pregnancy test result;
  21. Treated with any investigational drugs within 6 weeks prior to screening;
  22. Reported history of prescription drug abuse;
  23. Reported history of alcohol abuse
  24. Reported history of donation or acute loss of blood during the 90 days prior to screening;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequential arm ABC
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: Dorzagliatin
Glucokinase activator currently under development
Other Names:
  • HMS5552
Drug: Empagliflozin
Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
Other Names:
  • Jardiance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GMR for Cmax of dorzagliatin
Time Frame: up to 15 days
GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin
up to 15 days
Adverse events
Time Frame: up to 15 days
Number of participants with AEs
up to 15 days
Abnormal vital signs
Time Frame: up to 15 days
Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature)
up to 15 days
Abnormal clinical laboratory findings
Time Frame: up to 15 days
Number of participants with abnormal clinical laboratory findings
up to 15 days
12-lead ECG
Time Frame: up to 15 days
Number of participants with abnormal ECG VR,, PR, QRS and QT
up to 15 days
GMR for Cmax of empagliflozin
Time Frame: up to 10 days
Geometric mean ratio (GMR) between combination and empagliflozin monotherapy for Cmax of empagliflozin
up to 10 days
GMR for AUC0-24h of empagliflozin
Time Frame: up to 10 days
GMR between combination and empagliflozin in monotherapy for AUC0-24h of empagliflozin
up to 10 days
GMR for AUC0-24h of dorzagliatin
Time Frame: up to 15 days
GMR between combination and dorzagliatin in monotherapy for AUC0-24h of dorzagliatin
up to 15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
iCmax of glucose
Time Frame: up to 15 days
The incremental peak plasma concentration of glucose post OGTT
up to 15 days
iAUC0-4h of glucose
Time Frame: up to 15 days
The incremental area under the concentration-time curve of glucose in 4 hours post OGTT
up to 15 days
iCmax of C-peptide
Time Frame: up to 15 days
The incremental peak plasma concentration of C-peptide post OGTT
up to 15 days
iAUC0-4h of C-peptide
Time Frame: up to 15 days
The incremental area under the concentration-time curve of C-peptide in 4 hours post OGTT
up to 15 days
iCmax of insulin
Time Frame: up to 15 days
The incremental peak plasma concentration of insulin post OGTT
up to 15 days
iAUC0-4h of insulin
Time Frame: up to 15 days
The incremental area under the concentration-time curve of insulin in 4 hours post OGTT
up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hua Medicine Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory J Tracey, MD, Frontage Clinical Services, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMM0112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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