NCT04564872已完成3 期
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
Sichuan Haisco Pharmaceutical Group Co., Ltd2 个研究点 分布在 1 个国家目标入组 465 人开始时间: 2020年11月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- HbA1c Change From Baseline at Week 24
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HSK7653 10 mg
Experimental
干预措施: HSK7653 10 mg Q2W (Drug)
HSK7653 25 mg
Experimental
干预措施: HSK7653 25 mg Q2W (Drug)
Linagliptin 5 mg
Active Comparator
干预措施: Linagliptin 5 mg QD (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 24
时间窗: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
次要结局
- Incidence of Treatment-Emergent Adverse Events(Baseline, week 24 and week 52)
- 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)
- 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)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM SubjectsDiabetes Mellitus, Type 2NCT03141073Hua Medicine Limited767
终止
3 期
MK0767 and Metformin Combination Study (0767-028)Diabetes MellitusNCT00543738Merck Sharp & Dohme LLC114
终止
3 期
Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01834274Takeda96
已完成
3 期
HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and ExerciseDiabetes Mellitus, Type 2NCT04556851Sichuan Haisco Pharmaceutical Group Co., Ltd476
已完成
3 期
A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)Type 2 Diabetes MellitusNCT02532855Merck Sharp & Dohme LLC614