Diabetes Mellitus, Type 2
Conditions
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.
Interventions
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 (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.
DRUGLinagliptin 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.
Sponsors
Sichuan Haisco Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Change From Baseline at Week 24 | Baseline and week 24 | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With HbA1c <7.0% | Baseline, week 24 and week 52 | — |
| Percentage of Patients With HbA1c <6.5% | Baseline, week 24 and week 52 | — |
| FPG Change From Baseline at Week 24 and Week 52 | Baseline , week 24 and week 52 | — |
| 2h-PPG Change From Baseline at Week 24 and Week 52 | 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) |
| 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 | — |
| Weight Change From Baseline at Week 24 and Week 52 | Baseline, week 24 and week 52 | — |
Countries
China
Outcome results
None listed