Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of a pharmacogenetics-guided treatment, compared to standard optimized treatment, in patients with inadequately controlled type 2 diabetes. The main questions it aims to answer are:
- Is the disease better controlled when the treatment prescribed is based on the participant's pharmacogenetic profile?
- What medical problems do participants experience while taking the treatment?
Participants will:
- Take the treatment described according to the Summary of Product Characteristics (SmPC).
- Visit the clinic once every 12 weeks for checkups and tests.
- Keep a diary of their symptoms to inform the Investigator.
详细描述
Rationale:
Type 2 diabetes (T2D) is a growing disease that causes serious complications and represents a significant public health burden. Despite current therapies, many patients fail to achieve adequate glycemic control, highlighting the need for more personalized approaches. This study seeks to demonstrate that pharmacogenetics, which tailors treatments according to patients' genetic variations, can improve disease control, reduce adverse effects, and ultimately optimize healthcare resources, improving patients' quality of life.
Study Design:
This is a Phase IV, multicenter, randomized, controlled, two-arm, crossover clinical trial. The study will include at least 504 patients, who will be randomized in a 1:1 ratio to receive pharmacogenetics-guided treatment or standard treatment for type 2 diabetes. Once proven to meet eligibility criteria, patients will be assigned to a treatment arm and will participate in the study for the next 24 weeks.
Primary Objective:
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years old, included.
- •Body Mass Index (BMI) between 25-40 kg/m².
- •Diagnosis of Type 2 Diabetes (T2D) according to the American Diabetes Association (ADA) criteria.
- •Patients with T2D insufficiently controlled (Hemoglobin A1c (HbA1c) 7-9.5%) with current (≥6 months) "standard of care" treatment, excluding the use of insulin.
- •The subject has provided written informed consent prior to any study-specific procedure.
- •Able and willing to comply with requested study visits and procedures.
- •Contraceptive measures, only for female participants:
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- •Is a woman of non-childbearing potential (WONCBP) OR
- •Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period (to be effective before starting the intervention).
- •A WOCBP must have a negative urine pregnancy test before the first administration of study intervention.
排除标准
- •Treatment with insulin at the time of screening.
- •HbA1c >9.5% at screening.
- •Treatment with more than 3 glucose-lowering drugs at the time of screening.
- •Chronic renal disease defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (many glucose-lowering drugs are not approved or require dosage adjustments for use in these patients) at the screening visit.
- •Hepatic insufficiency, which contraindicates the use of glucose-lowering drugs.
- •Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment in another investigational drug study.
- •Pregnancy or lactation.
- •Women of childbearing potential with no effective contraceptive methods.
- •New York Heart Association (NYHA) Class III or IV congestive heart failure.
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- •Subject is study staff directly involved with the study or is a family member of the investigational study staff.
- •Life expectancy predicted to be <2 years.
研究组 & 干预措施
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Metformin (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Canagliflozin (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: pioglitazone (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Sitagliptin (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Vildagliptin (Galvus) (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: linagliptin (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Semaglutide 1.0 mg (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Empagliflozin (BI 10773) (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Canagliflozin (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Dulaglutide (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Semaglutide 1.0 mg (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Dapagliflozin (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Metformin (Drug)
Pharmacogenetic-guided treatment
Patient treatment will be selected according to previously identified genetic variations. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Empagliflozin (BI 10773) (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: linagliptin (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Dulaglutide (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: pioglitazone (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Dapagliflozin (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Sitagliptin (Drug)
Standard treatment
Patient treatment will be selected according to clinical guidelines. Study treatments and posology from enrollment to the end of treatment at Week 24 can be:
- Metformin (daily dose 2000 mg).
- GLP1 receptor analogs: dulaglutide and semaglutide.
- SGLT2 inhibitors: empagliflozin, canagliflozin and dapagliflozin.
- Pioglitazone.
- DPP4 inhibitors: sitagliptin, vildagliptin and linagliptin. Or a combination of these drugs. Except of metformin, which 2000 mg is the daily dose stablished in this study, for the rest of treatment options, SmPCs guidelines of each treatment will be followed to stablished the daily dose.
干预措施: Vildagliptin (Galvus) (Drug)
结局指标
主要结局
Comparison of HbA1c ≤7% goal at Week 24 between Pharmacogenetic-Guided and Standard Treatment in Type 2 Diabetes
时间窗: From baseline to the end of treatment at 24 weeks
The primary objective is to compare the proportion of patients achieving HbA1c ≤7% at Week 24 between pharmacogenetic-guided treatment arm and standard treatment arm in subjects with insufficiently controlled type 2 diabetes. The null hypothesis is that the proportion of patients achieving this goal is equal in both the pharmacogenetic-guided and standard treatment groups.
次要结局
- Comparison of Pharmacogenetic Markers and Treatment Response Pre-Randomization(Before randomization to the end of treatment at 24 weeks)