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

NCT04556851 | Completed Phase 3 DMC

• 2 other identifiers: HSK7653-301CTR20201759
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

T2DM

Outcome Measures

Primary Outcomes (1)

• HbA1c change from baseline at week 24

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

  Baseline and week 24

Secondary Outcomes (10)

• The Safety of HSK7653 at Week 24 and Week 52

  Baseline, week 24 and week 52

• Percentage of Patients With HbA1c <7.0%

  Baseline, week 24 and week 52

• Percentage of Patients With HbA1c <6.5%

  Baseline, week 24 and week 52

• FPG Change From Baseline at Week 24 and Week 52

  Baseline, week 24 and week 52

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

  Baseline, week 24 and week 52

Study Arms (3)

HSK7653 10 mg

EXPERIMENTAL

Drug: HSK7653 10 mg Q2W

HSK7653 25 mg

EXPERIMENTAL

Drug: HSK7653 25 mg Q2W

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK7653 10 mg Q2W DRUG

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.

HSK7653 10 mg

HSK7653 25 mg Q2W DRUG

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.

HSK7653 25 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Zhujiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

Location

Related Publications (1)

• Gao L, Bian F, Pan T, Jiang H, Feng B, Jiang C, Sun J, Xiao J, Yan P, Ji L. Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Obes Metab. 2025 Jan;27(1):280-290. doi: 10.1111/dom.16014. Epub 2024 Oct 21.

  PMID: 39434431 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: September 29, 2020
• Primary Completion: January 10, 2022
• Study Completion: August 8, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)