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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564872
• Other study ID #: HSK7653-302
• Secondary ID: CTR20201724
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2020
• Est. completion date: August 29, 2022

Study information

• Verified date: December 2022
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: August 29, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HSK7653 10 mg Q2W
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 25 mg Q2W
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.
• Linagliptin 5 mg QD
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.

Locations

Country	Name	City	State
China	Inner Mongolia Baogang Hospital	Baotou	Inner Mongolia
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Haisco Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Change From Baseline at Week 24	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24	Baseline and week 24
Secondary	Incidence of Treatment-Emergent Adverse Events	The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)	Baseline, week 24 and week 52
Secondary	Percentage of Patients With HbA1c <7.0%		Baseline, week 24 and week 52
Secondary	Percentage of Patients With HbA1c <6.5%		Baseline, week 24 and week 52
Secondary	FPG Change From Baseline at Week 24 and Week 52		Baseline , week 24 and week 52
Secondary	2h-PPG Change From Baseline at Week 24 and Week 52		Baseline, week 24 and week 52
Secondary	Weight Change From Baseline at Week 24 and Week 52		Baseline, week 24 and week 52
Secondary	Fasting C-peptide Change From Baseline at Week 24 and Week 52		Baseline, week 24 and week 52
Secondary	Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52		Baseline, week 24 and week 52
Secondary	Pancreatic ß-cell function Change (Calculated by HOMA-ß) From Baseline at Week 24 and Week 52		Baseline, week 24 and week 52
Secondary	Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52		Baseline, week 24 and week 52