Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
NCT ID: NCT02077452
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2014-03-31
2014-10-31
Brief Summary
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Detailed Description
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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:
1. To determine the single dose and steady state pharmacokinetics of HMS5552 in patients with type 2 diabetes
2. To evaluate the single dose and steady state pharmacodynamics of HMS5552 in patients with type 2 diabetes
3. 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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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HMS5552 dose 1
HMS5552 25\~400mg. Oral administration, twice per day.
HMS5552
Placebo
HMS5552 dose 2
HMS5552 25\~400mg. Oral administration, twice per day.
HMS5552
Placebo
HMS5552 dose 3
HMS5552 25\~400mg. Oral administration, twice per day.
HMS5552
Placebo
HMS5552 dose 4
HMS5552 25\~400mg. Oral administration, once per day.
HMS5552
Placebo
HMS5552 dose 5
HMS5552 25\~400mg. Oral administration, twice per day.
HMS5552
Placebo
Interventions
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HMS5552
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hua Medicine Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dalong ZHU, MD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other Identifiers
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HMM0102
Identifier Type: -
Identifier Source: org_study_id
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