search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HSK7653 10 mg Q2W
HSK7653 25 mg Q2W
Linagliptin 5 mg QD
Sponsored by
Sichuan Haisco Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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 who have planned parenthood;
  • Contraindication for empagliflozin or linagliptin;
  • Other protocol-defined inclusion/exclusion criteria.

Sites / Locations

  • Peking University People's Hospital
  • Inner Mongolia Baogang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

HSK7653 10 mg

HSK7653 25 mg

Linagliptin 5 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Percentage of Patients With HbA1c <7.0%
Percentage of Patients With HbA1c <6.5%
FPG Change From Baseline at Week 24 and Week 52
2h-PPG Change From Baseline at Week 24 and Week 52
Weight Change From Baseline at Week 24 and Week 52
Fasting C-peptide Change From Baseline at Week 24 and Week 52
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52

Full Information

First Posted
September 14, 2020
Last Updated
December 9, 2022
Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04564872
Brief Title
HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Official Title
A Multicenter, Randomized, Double-Blind, Active-Controlled Trial of the Efficacy and Safety of Adding HSK7653 to Metformin in Chinese Patients With Type 2 Diabetes and Inadequate Glycaemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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, or linagliptin, and with matching placebo respectively. During the open-label period, all participants will receive 25 mg dose of HSK7653. All participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
465 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HSK7653 10 mg
Arm Type
Experimental
Arm Title
HSK7653 25 mg
Arm Type
Experimental
Arm Title
Linagliptin 5 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HSK7653 10 mg Q2W
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HSK7653 25 mg Q2W
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Linagliptin 5 mg QD
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline at Week 24
Description
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Time Frame
Baseline, week 24 and week 52
Title
Percentage of Patients With HbA1c <7.0%
Time Frame
Baseline, week 24 and week 52
Title
Percentage of Patients With HbA1c <6.5%
Time Frame
Baseline, week 24 and week 52
Title
FPG Change From Baseline at Week 24 and Week 52
Time Frame
Baseline , week 24 and week 52
Title
2h-PPG Change From Baseline at Week 24 and Week 52
Time Frame
Baseline, week 24 and week 52
Title
Weight Change From Baseline at Week 24 and Week 52
Time Frame
Baseline, week 24 and week 52
Title
Fasting C-peptide Change From Baseline at Week 24 and Week 52
Time Frame
Baseline, week 24 and week 52
Title
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
Time Frame
Baseline, week 24 and week 52
Title
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
Title
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52
Time Frame
Baseline, week 24 and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 who have planned parenthood; Contraindication for empagliflozin or linagliptin; Other protocol-defined inclusion/exclusion criteria.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Inner Mongolia Baogang Hospital
City
Baotou
State/Province
Inner Mongolia
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs