NCT02773368已完成3 期
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin
排除标准
- •Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products
研究组 & 干预措施
IDegLira
Experimental
干预措施: insulin degludec/liraglutide (Drug)
IGlar
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, Week 26
The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
次要结局
- Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate(After 26 weeks)
- Change in Body Weight(Week 0, Week 26)
- Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes(Week 0-26)
- Insulin Dose, Total Daily Dose (U)(After 26 weeks)
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 26)
- Number of Treatment-emergent Adverse Events(Week 0-26)
- Responder (Yes/No) for HbA1c Below 7.0%(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 26 weeks)
- Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain(After 26 weeks)
- Change From Baseline After 26 Weeks in Waist Circumference(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: Cholesterol(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: Triglycerides(After 26 weeks)
- Change From Baseline in Fasting Lipid Profile: Free Fatty Acids(After 26 weeks)
- Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile(After 26 weeks)
- Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile(After 26 weeks)
- Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments(After 26 weeks)
- Change From Baseline in Systolic Blood Pressure(After 26 weeks)
- Change From Baseline in Diastolic Blood Pressure(After 26 weeks)
- Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks(Week 0-26)
- Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks(Week 0-26)
- Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)(After 26 weeks)
- Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography(After 26 weeks)
- Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)(After 26 weeks)
- Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)(After 26 weeks)
研究者
研究点 (1)
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