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

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: HSK7653 10 mg Q2W

Drug: Linagliptin 5 mg QD

Drug: HSK7653 25 mg Q2W

Study type

Interventional

Funder types

Industry

Identifiers

NCT04564872

HSK7653-302

CTR20201724 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

465 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.