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CompletedNCT04556851Updated Dec 12, 2022

HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Phase 3 interventional study of HSK7653 10 mg Q2W and HSK7653 25 mg Q2W in Diabetes Mellitus, Type 2, sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy of HSK7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 diabetes who are insufficient glycaemic control with diet and exercise.

Read the detailed description

The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653 and matching placebo, or placebo only. During the open-label period, all participants will receive 25 mg dose of HSK7653.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • T2DM
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 476 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years, Male and female patients;
  • Type 2 diabetes mellitus;
  • Control the blood glucose level only with diet and exercise in last 8 weeks;
  • Did not receive regular long-term medication of oral hypoglycemic drugs or insulin within 1 year prior to informed consent;
  • HbA1c in the range of ≥7.5 to ≤11.0% at screening;
  • FPG \< 15 mmol/L at screening;
  • BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.

Exclusion criteria

Exclusion Criteria:

  • Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
  • History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
  • Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent;
  • Serious gastrointestinal disease within 2 weeks prior to informed consent;
  • Serious infection, trauma and surgery within 3 months prior to informed consent;
  • History of treatment with Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
  • Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
  • Hemoglobin (HGB) \< 10.0 g/dL(100 g/L);
  • Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
  • Active infectious diseases;
  • Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
  • Women who are nursing or pregnant, or subjects with birth plans;
  • Contraindication for metformin;
  • Other protocol-defined inclusion/exclusion criteria.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
476 participants (actual)

Study arms

  • Experimental
    HSK7653 10 mg

    Drug: HSK7653 10 mg Q2W

  • Experimental
    HSK7653 25 mg

    Drug: HSK7653 25 mg Q2W

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHSK7653 10 mg Q2W

    HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.

  • DrugHSK7653 25 mg Q2W

    HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.

  • DrugPlacebo

    Placebo 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.

06

What researchers measure

Primary outcomes

  1. HbA1c change from baseline at week 24

    Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

    Time frame: Baseline and week 24

Secondary outcomes

  1. The Safety of HSK7653 at Week 24 and Week 52

    Incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)

    Time frame: Baseline, week 24 and week 52

  2. Percentage of Patients With HbA1c <7.0%

    Time frame: Baseline, week 24 and week 52

  3. Percentage of Patients With HbA1c <6.5%

    Time frame: Baseline, week 24 and week 52

  4. FPG Change From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  5. 2h-PPG Change From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  6. Weight Change From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  7. Fasting C-peptide Change From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  8. Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  9. Pancreatic β-cell function Change (Calculated by HOMA-β ) From Baseline at Week 24 and Week 52

    Time frame: Baseline, week 24 and week 52

  10. Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia

    Time frame: Baseline, week 24 and week 52

07

Study locations

2 sites
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
  • Zhujiang Hospital of Southern Medical University
    Zhujiang, Guangdong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04556851
Lead sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
Responsible party
Sponsor
First posted
Sep 21, 2020
Start date
Sep 29, 2020
Primary completion
Jan 10, 2022
Completion
Aug 8, 2022
Last update
Dec 12, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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