NCT06059326

Brief Summary

To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

September 23, 2023

Last Update Submit

September 23, 2023

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.

    From baseline to up to 2 weeks after last dose for a total of approximately 14 weeks

Secondary Outcomes (7)

  • Peak plasma concentration (Cmax) of HSK7653

    Day 1 to Day 43

  • Area under the plasma concentration versus time curve (AUC) of HSK7653

    Day 1 to Day 43

  • Half-life (t1/2) of HSK7653

    Day 1 to Day 43

  • Change from baseline in dipeptidyl peptidase-IV (DPP-4) inhibition rate

    Day 1 to Day 84

  • Change from baseline in GLP-1

    Day 1 to Day 84

  • +2 more secondary outcomes

Study Arms (4)

HSK7653 10 mg

EXPERIMENTAL
Drug: HSK7653 10 mg

HSK7653 25 mg

EXPERIMENTAL
Drug: HSK7653 25 mg

HSK7653 50 mg

EXPERIMENTAL
Drug: HSK7653 50 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HSK7653 10 mgDRUG

Tablet, HSK7653 10 mg Q2W, 12 weeks

HSK7653 10 mg
HSK7653 25 mgDRUG

Tablet, HSK7653 25 mg Q2W, 12 weeks

HSK7653 25 mg
HSK7653 50 mgDRUG

Tablet, HSK7653 50 mg Q2W, 12 weeks

HSK7653 50 mg
PlaceboDRUG

Tablet, 0 mg Q2W, 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 and Age ≤70 years
  • 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

You may not qualify if:

  • Non-type 2 diabetes mellitus: Type 1 diabetes mellitus, gestational diabetes history;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2023

First Posted

September 28, 2023

Study Start

January 22, 2019

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)