Clinical trial NCT04564872: HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: HbA1c Change From Baseline at Week 24
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients With HbA1c <7.0%
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients With HbA1c <6.5%
timeFrame: Baseline, week 24 and week 52
measure: FPG Change From Baseline at Week 24 and Week 52
timeFrame: Baseline , week 24 and week 52
measure: 2h-PPG Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Weight Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Fasting C-peptide Change From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52
timeFrame: Baseline, week 24 and week 52
measure: Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52
timeFrame: Baseline, week 24 and week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
state: Inner Mongolia
Study officials:
References: