HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT04564872 | Completed Phase 3 DMC

• 2 other identifiers: HSK7653-302CTR20201724
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.

Conditions

Diabetes Mellitus, Type 2

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)

• Incidence of Treatment-Emergent Adverse Events

  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

Linagliptin 5 mg

ACTIVE COMPARATOR

Drug: Linagliptin 5 mg QD

Interventions

HSK7653 10 mg Q2W DRUG

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

HSK7653 25 mg

Linagliptin 5 mg QD DRUG

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

Linagliptin 5 mg

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;
• Insufficient glycaemic control with diet/exercise therapy and metformin agent monotherapy;
• Did not receive regular long-term medication of oral hypoglycemic drugs (except metformin) 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 who have planned parenthood;
• Contraindication for empagliflozin or linagliptin;

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

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 25, 2020
• Study Start: November 13, 2020
• Primary Completion: January 21, 2022
• Study Completion: August 29, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)