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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre, Randomised, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of HSK7653 as Monotherapy in Chinese Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: HSK7653 10 mg Q2W
* Drug: HSK7653 25 mg Q2W
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK7653 10 mg<br> | Drug: HSK7653 10 mg Q2W<br>* 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.<br>|
| Experimental: HSK7653 25 mg<br> | Drug: HSK7653 25 mg Q2W<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline at week 24 | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | Baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety of HSK7653 at Week 24 and Week 52 | Incidence of Treatment-Emergent Adverse Events over time (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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM