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Type 2 Diabetic PatientsPhase 1NCT03006159

A Phase 1, Randomized, Placebo-controlled, Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Chinese Type 2 Diabetic Patients

A Phase 1 study testing SHR0534 in people with Type 2 Diabetic Patients, run by Jiangsu HengRui Medicine Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with dose of 5 mg, 10mg and 25 mg. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetic Patients
What is being tested?
SHR0534
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
No sites listed yet
Study dates
Mar 2015to Mar 2016
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

  • Type 2 diabetes diagnosed for more than 3 months;
  • HbA1c between ≥7.0 and ≤10.5% for naive patients, or ≥6.5 and ≤9.5% for patients treated with single oral drug, with FPG ≤13.9 mmol/L at randomization;
  • Body Mass Index (BMI) between 18 and 40 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
  • Agree to stop any other drugs for diabetes during washout and study period;
  • Serum C peptide concentration ≥0.8ng/mL at randomization.

Who cannot join

  • Participated any drug clinical trials within 3 months or ≥3 times during the last year, or had blood donation/loss≥400mL or as Blood recipient within 3 months before randomization;
  • History use of Insulin within 6 months;
  • Drug or alcohol abuse within 6 months;
  • Use any other hypoglycemic drugs or weight reducing drugs within 3 months, or use any grug or dietary supplements within 1 weeks prior to screening ;
  • Underwent surgical procedures within 1 month prior to screening, or planned major surgical procedures during the study period;
  • Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
Show all 19Show fewer
  • With active hepatitis;
  • Uncontrolled endocrine system diseases (such as hyperthyroidism, hypothyroidism, Cushing syndrome, multiple endocrine neoplasia);
  • Uncontrolled hypertension with systolic blood pressure (SBP) > 160mmHg and / or diastolic pressure (DBP) > 100 mmHg after drug treatment;
  • History of recurrent severe hypoglycemia;
  • With severe chronic gastrointestinal disease (e.g., an active ulcer within 6 months) or treatment that may affect drug absorption (e.g., gastrointestinal surgery);
  • With any cancer (other than skin basal cell carcinoma) that has been treated or untreated within the last 5 years;
  • History of decompensated heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, persistent myocardial infarction, and the clinical significance of arrhythmia (such as frequent contractions), or had coronary artery bypass grafting or percutaneous coronary intervention within 6 months;
  • History of acute metabolic complications, or proliferative retinopathy or maculopathy which required acute treatment within 6 months;
  • Severe trauma or severe infection that may affect glycemic control within 1 months before screening;
  • AST, ALT or TBIL>1.5×UNL, or Cre>1.5 mg/dL(male)/1.4 mg/dL(female), or ACR>300mg/g at screening;
  • Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
  • With clinical significance abnormal of ECGs, such as II or III degree atrioventricular block (except right bundle branch block), long QT syndrome or QTc>500 MS;
  • Subject was not suitable for the study as determined by the Investigator.

About this study

This is a randomized, placebo-controlled, multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with dose of 5 mg, 10mg and 25 mg. Chinese Type 2 Diabetic patients will be randomized in each cohort to receive the study drug or placebo.

Being tested
SHR0534, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR0534Drug

  • PlaceboDrug

Study groups in NCT03006159
Study groupRoleWhat they receive
Cohort 1ExperimentalTwelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 5 mg SHR0534 or matching placebo.
Receives: Drug: SHR0534; Drug: Placebo
Cohort 2ExperimentalTwelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 10 mg SHR0534 or matching placebo.
Receives: Drug: SHR0534; Drug: Placebo
Cohort 3ExperimentalTwelve Type 2 Diabetic Patients were randomized in 5:1 ratio to receive multiple (30 days) oral dose of 25 mg SHR0534 or matching placebo.
Receives: Drug: SHR0534; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events

    Measured: From baseline up to 8 days after last treatment (Day 38)

  2. Area under the plasma concentration curve after the first and last multiple oral dose (AUC)

    Measured: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose

  3. Peak plasma concentration (Cmax) after the first and last multiple oral dose

    Measured: From time 0 to 24 hours for the first dose, and from time 0 to 192 hours after the last dose

  4. Terminal elimination halflife (t½) for SHR0534 after the last multiple oral dose

    Measured: From time 0 to 192 hours after the last dose

  5. Changes in the concentrations of blood glucose and insulin after multiple oral dose

    Measured: From baseline up to 24 hours after last treatment (Day 31)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006159
Sponsor's protocol ID
SHR0534-Ib
Status last verified
Dec 2016
First submitted
28 Dec 2016
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR0534 in people with Type 2 Diabetic Patients, run by Jiangsu HengRui Medicine Co., Ltd..

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 19 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 30 Dec 2016. 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?

Number of treatment emergent adverse events (time frame: From baseline up to 8 days after last treatment (Day 38)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03006159.

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 30 Dec 2016.

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