Type 2 Diabetes MellitusPhase 1NCT02077452
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
A Phase 1 study testing HMS5552 in people with Type 2 Diabetes Mellitus, run by Hua Medicine Limited.
Trial summary
The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HMS5552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects with type 2 diabetes
- Age: 18 to 65 years
- BMI: 20 to 29 kg/m2
- Mentally, physically and legally eligible to give informed consent.
- Willingness to adhere to the protocol requirement.
Who cannot join
- Subjects with type 1 diabetes
- Episodes of hypoglycemia
- Unstable cardiovascular diseases
- Hepatic diseases
- Kidney disease
- Mental or central nervous system diseases
- Clinical abnormal findings in ECG, labs and physical exams
About this study
Official title: A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus
The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.
Read the detailed description
This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.
The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.
The secondary objectives include:
- To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
- To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
- To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics
A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HMS5552, Placebo
- Keywords
- Glucokinase activator, Phase I, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMS5552Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HMS5552 dose 1 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 2 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 3 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 4 | Experimental | HMS5552 25~400mg. Oral administration, once per day. Receives: Drug: HMS5552; Drug: Placebo |
| HMS5552 dose 5 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. Receives: Drug: HMS5552; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
Measured: up to 15 days after study drug administration
Secondary outcomes (3)
The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index.
- Single dose (Day 1) plasma and urine pharmacokinetic parameters (postprandial)
- Single dose (Day 3) plasma and urine pharmacokinetic parameters (fasting)
- Steady state (Day 7) plasma and urine pharmacokinetic parameters (postprandial)
- Steady state (Day 8) plasma and urine pharmacokinetic parameters (fasting)
Measured: up to day 8 post-dose
The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose.
Measured: up to 4 hour post-dose and up to 24 hour post-dose
Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial)
Measured: up to 6 hour post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalong ZHU, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077452
- Sponsor's protocol ID
- HMM0102
- Status last verified
- Nov 2017
- First submitted
- 2 Mar 2014
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HMS5552 in Adult Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02077452
- Acronym / sponsor ID
- HMM0102
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Glucokinase activator, Phase I, Type 2 diabetes mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Mar 2014 (estimated)
- 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.
The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.
Detailed description
This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.
The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.
The secondary objectives include:
- To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
- To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
- To further explore food-effect on HMS5552 pharmacokinetics and pharmacodynamics
A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HMS5552 dose 1 | Experimental | Drug: HMS5552, Drug: PlaceboHMS5552 25~400mg. Oral administration, twice per day. |
| HMS5552 dose 2 | Experimental | Drug: HMS5552, Drug: PlaceboHMS5552 25~400mg. Oral administration, twice per day. |
| HMS5552 dose 3 | Experimental | Drug: HMS5552, Drug: PlaceboHMS5552 25~400mg. Oral administration, twice per day. |
| HMS5552 dose 4 | Experimental | Drug: HMS5552, Drug: PlaceboHMS5552 25~400mg. Oral administration, once per day. |
| HMS5552 dose 5 | Experimental | Drug: HMS5552, Drug: PlaceboHMS5552 25~400mg. Oral administration, twice per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects with type 2 diabetes
- Age: 18 to 65 years
- BMI: 20 to 29 kg/m2
- Mentally, physically and legally eligible to give informed consent.
- Willingness to adhere to the protocol requirement.
Key exclusion criteria (7 listed)
- Subjects with type 1 diabetes
- Episodes of hypoglycemia
- Unstable cardiovascular diseases
- Hepatic diseases
- Kidney disease
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 |
|---|---|---|
| HMS5552 | Drug | HMS5552 dose 1, HMS5552 dose 2, HMS5552 dose 3, HMS5552 dose 4, HMS5552 dose 5 |
| Placebo | Drug | HMS5552 dose 1, HMS5552 dose 2, HMS5552 dose 3, HMS5552 dose 4, HMS5552 dose 5 |
Primary outcome
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements.
Time frame: up to 15 days after study drug administration
3 secondary outcomes
The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index.
Time frame: up to day 8 post-dose
The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose.
Time frame: up to 4 hour post-dose and up to 24 hour post-dose
Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial)
Time frame: up to 6 hour post-dose
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 20 Nov 2017.
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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.
Dalong ZHU, MD principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMS5552 in people with Type 2 Diabetes Mellitus, run by Hua Medicine Limited.
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 7 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements. (time frame: up to 15 days after study drug administration). 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 20 Nov 2017.