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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: HSK7653 10 mg Q2W; Drug: HSK7653 25 mg Q2W; Drug: Placebo

• Registration Number: NCT04556851
• Lead Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd

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.

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.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2020-09-29
• Primary Completion: 2022-01-10
• Study Completion: 2022-08-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSK7653 10 mg	HSK7653 10 mg Q2W	-
HSK7653 25 mg	HSK7653 25 mg Q2W	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c change from baseline at week 24	Baseline and week 24	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

Secondary Outcome Measures

Name	Time	Method
The Safety of HSK7653 at Week 24 and Week 52	Baseline, week 24 and week 52	Incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Percentage of Patients With HbA1c <6.5%	Baseline, week 24 and week 52
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52	Baseline, week 24 and week 52
Pancreatic β-cell function Change (Calculated by HOMA-β ) From Baseline at Week 24 and Week 52	Baseline, week 24 and week 52
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia	Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%	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
Weight Change From Baseline at Week 24 and Week 52	Baseline, week 24 and week 52
Fasting C-peptide Change From Baseline at Week 24 and Week 52	Baseline, week 24 and week 52

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Zhujiang Hospital of Southern Medical University; 🇨🇳 Zhujiang, Guangdong, China