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

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd; Sichuan Haisco Pharmaceutical Group Co., Ltd.
• Treatments: Linagliptin

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.