PatientsPhase 1NCT03790839
Drug Interaction Study Between Dorzagliatin and Sitagliptin
A Phase 1 study testing Sitagliptin and Dorzagliatin in people with Patients, run by Hua Medicine Limited at 1 site in United States.
Trial summary
This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Patients
- What is being tested?
- Sitagliptin and Dorzagliatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 30 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Fasting C-peptide test result >0.3 nmol/L (>0.90 ng/mL);
- HbA1c ≥7% and ≤10.5%;
Who cannot join
- Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
- Type 1 diabetes mellitus;
- Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
- Known contraindications to sitagliptin;
- Clinically significant gastrointestinal disorder;
- History or symptoms of clinically significant cardiovascular disease within one year prior to screening;
Show all 25Show fewer
- 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;
- 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 sitagliptin;
- Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
- Systolic blood pressure <90 or >160 mmHg or diastolic blood pressure <60 or >100 mmHg at screening;
- A hospital admission or major surgery within 90 days prior to screening;
- Uncontrolled hypertriglyceridemia >500 mg/dL;
- Positive blood screen for HIV, hHBsAg, or hepatitis C antibody;
- Positive pregnancy test result;
- Female is breast-feeding or planning to become pregnant;
- Treated with any investigational drugs within 6 weeks prior to screening;
- Reported history of prescription drug abuse;
- Reported history of alcohol abuse;
- Reported history of donation or or acute loss of blood during the 90 days prior to screening;
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services Inc.
Hackensack, New Jersey, 07601
About this study
Official title: A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Sitagliptin 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 sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.
- Conditions
- Patients
- Being tested
- Sitagliptin, Dorzagliatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin (Januvia® 100 mg tablets for oral administration)
DorzagliatinDrug
Also called HMS5552
Glucokinase activator currently under development
| Study group | Role | What they receive |
|---|---|---|
| Sequential arm ABC | Experimental | A: Sitagliptin 100 mg QD in the morning on Days 1-5; B: Sitagliptin 100 mg QD 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. Receives: Drug: Sitagliptin; Drug: Dorzagliatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean ratio (GMR) for Cmax of sitagliptin
GMR between combination and sitagliptin monotherapy for Cmax of sitagliptin
Measured: up to 10 days
GMR for AUC0-24h of sitagliptin
GMR between combination and sitagliptin monotherapy for AUC0-24h of sitagliptin
Measured: up to 10 days
GMR for Cmax of dorzagliatin
GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin
Measured: up to 15 days
GMR for AUC0-24h of dorzagliatin
GMR between combination and dorzagliatin monotherapy for AUC0-24h of dorzagliatin
Measured: up to 15 days
Adverse events
Number of participants with AEs
Measured: up to 15 days
Abnormal vital signs
Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature)
Measured: up to 15 days
Abnormal clinical laboratory findings
Number of participants with abnormal clinical laboratory findings
Measured: up to 15 days
12-lead ECG
Number of participants with abnormal ECG VR,, PR, QRS and QT
Measured: up to 15 days
Secondary outcomes (6)
iCmax of glucose
The incremental peak plasma concentration of glucose post OGTT
Measured: up to 15 days
iAUC0-4h of glucose
The incremental area under the concentration-time curve of glucose in 4 hours post OGTT
Measured: up to 15 days
iCmax of C-peptide
The incremental peak plasma concentration of C-peptide post OGTT
Measured: up to 15 days
iAUC0-4h of C-peptide
The incremental area under the concentration-time curve of C-peptide in 4 hours post OGTT
Measured: up to 15 days
iCmax of GLP-1
The incremental peak plasma concentration of GLP-1 post OGTT
Measured: up to 15 days
iAUC0-4h of GLP-1
The incremental area under the concentration-time curve of GLP-1 in 4 hours post OGTT
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start31 Jan 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Tracey, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790839
- Sponsor's protocol ID
- HMM0111
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Sitagliptin in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03790839
- Acronym / sponsor ID
- HMM0111
- Conditions
- Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential arm ABC | Experimental | Drug: Sitagliptin, Drug: DorzagliatinA: Sitagliptin 100 mg QD in the morning on Days 1-5; B: Sitagliptin 100 mg QD 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Fasting C-peptide test result >0.3 nmol/L (>0.90 ng/mL);
- HbA1c ≥7% and ≤10.5%;
Key exclusion criteria (25 listed)
- Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
- Type 1 diabetes mellitus;
- Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
- Known contraindications to sitagliptin;
- Clinically significant gastrointestinal disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin (Januvia® 100 mg tablets for oral administration) | Drug | Sequential arm ABC |
| DorzagliatinAlso: HMS5552Glucokinase activator currently under development | Drug | Sequential arm ABC |
Primary outcome
Geometric mean ratio (GMR) for Cmax of sitagliptin
Time frame: up to 10 days
GMR between combination and sitagliptin monotherapy for Cmax of sitagliptin
GMR for AUC0-24h of sitagliptin
Time frame: up to 10 days
GMR between combination and sitagliptin monotherapy for AUC0-24h of sitagliptin
GMR for Cmax of dorzagliatin
Time frame: up to 15 days
GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin
GMR for AUC0-24h of dorzagliatin
Time frame: up to 15 days
GMR between combination and dorzagliatin monotherapy for AUC0-24h of dorzagliatin
Adverse events
Time frame: up to 15 days
Number of participants with AEs
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)
Abnormal clinical laboratory findings
Time frame: up to 15 days
Number of participants with abnormal clinical laboratory findings
12-lead ECG
Time frame: up to 15 days
Number of participants with abnormal ECG VR,, PR, QRS and QT
6 secondary outcomes
iCmax of glucose
Time frame: up to 15 days
iAUC0-4h of glucose
Time frame: up to 15 days
iCmax of C-peptide
Time frame: up to 15 days
iAUC0-4h of C-peptide
Time frame: up to 15 days
iCmax of GLP-1
Time frame: up to 15 days
iAUC0-4h of GLP-1
Time frame: up to 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Patients
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingObservational study
Results of Medical and Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma of Patient's
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Tracey, MD principal investigator
Frontage Clinical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sitagliptin and Dorzagliatin in people with Patients, run by Hua Medicine Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean ratio (GMR) for Cmax of sitagliptin (time frame: up to 10 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.