HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04564872
- Lead Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 465
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HSK7653 10 mg HSK7653 10 mg Q2W - HSK7653 25 mg HSK7653 25 mg Q2W - Linagliptin 5 mg Linagliptin 5 mg QD -
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 24 Baseline and week 24 Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
- Secondary Outcome Measures
Name Time Method FPG Change From Baseline at Week 24 and Week 52 Baseline , week 24 and week 52 Percentage of Patients With HbA1c <7.0% Baseline, week 24 and week 52 2h-PPG Change From Baseline at Week 24 and Week 52 Baseline, week 24 and week 52 Percentage of Patients With HbA1c <6.5% Baseline, week 24 and week 52 Incidence of Treatment-Emergent Adverse Events Baseline, week 24 and week 52 The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Weight Change From Baseline at Week 24 and Week 52 Baseline, week 24 and week 52 Fasting C-peptide Change From Baseline at Week 24 and Week 52 Baseline, week 24 and week 52 Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52 Baseline, week 24 and week 52 Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52 Baseline, week 24 and week 52 Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52 Baseline, week 24 and week 52
Trial Locations
- Locations (2)
Inner Mongolia Baogang Hospital
🇨🇳Baotou, Inner Mongolia, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China