Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
NCT ID: NCT06059326
Last Updated: 2023-09-28
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
PHASE2
48 participants
INTERVENTIONAL
2019-01-22
2019-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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HSK7653 10 mg
HSK7653 10 mg
Tablet, HSK7653 10 mg Q2W, 12 weeks
HSK7653 25 mg
HSK7653 25 mg
Tablet, HSK7653 25 mg Q2W, 12 weeks
HSK7653 50 mg
HSK7653 50 mg
Tablet, HSK7653 50 mg Q2W, 12 weeks
Placebo
Placebo
Tablet, 0 mg Q2W, 12 weeks
Interventions
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HSK7653 10 mg
Tablet, HSK7653 10 mg Q2W, 12 weeks
HSK7653 25 mg
Tablet, HSK7653 25 mg Q2W, 12 weeks
HSK7653 50 mg
Tablet, HSK7653 50 mg Q2W, 12 weeks
Placebo
Tablet, 0 mg Q2W, 12 weeks
Eligibility Criteria
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Inclusion Criteria
* T2DM patients,
* Control the blood glucose level only with diet and exercise in last 3 months;
* BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
* HbA1c ≥7.0% and HbA1c \<10.0%
* FPG \<13.9 mmol/L
Exclusion Criteria
* History of acute complications of diabetes (diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome or lactic acidosis);
* History of chronic complications of severe diabetes (retinal proliferative disease, severe diabetic neuropathy or intermittent claudication confirmed by fundus examination during screening);
* Patients who used systemic glucocorticoids within 3 months prior to screening had severe infections or major surgeries and transplants within 3 months;
* Three or more episodes of hypoglycemia occurred in the six months prior to screening;
* History of hyperthyroidism within 6 months before screening;
* Severe cardiovascular disease. ;
* Medical conditions that may significantly affect drug absorption, distribution, metabolism, and excretion within 2 weeks prior to screening;
* Liver function tests abnormal;
* Moderate or severe renal impairment;
* Medical history or clinical evidence of pancreatic injury or pancreatitis, or abnormalities in lipase and amylase judged by investigators to be clinically significant;
* Patients with a history of hypertension who regularly take antihypertensive therapy for over 4 weeks still have poor control, SBP \> 160 mmHg and (or) DBP \> 100 mmHg;
* Patients with uncontrolled hyperlipidemia.
18 Years
75 Years
ALL
No
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking university people's hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HSK7653-201
Identifier Type: -
Identifier Source: org_study_id
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