NCT02963922已完成3 期
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
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
- 396
- 试验地点
- 1
- 主要终点
- Participants Losing at Least 5% of Baseline Body Weight
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Diagnosed with type 2 diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone, SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or above 27 kg/m^2 - Age at least 18 years at the time of signing informed consent
排除标准
- •Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator - Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening - Treatment with a DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening - Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner - Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis (acute or chronic) - History of major depressive disorder within the past 2 years - Any lifetime history of a suicide attempt - Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the past 5 years
研究组 & 干预措施
liraglutide 3.0 mg
Experimental
干预措施: Liraglutide 3.0 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Participants Losing at Least 5% of Baseline Body Weight
时间窗: Week 56
The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Change in Body Weight (%)
时间窗: Week 0, week 56
Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
次要结局
- Change in Waist Circumference(Week 0, week 56)
- Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score(Week 56)
- Change in FPG(Week 0, week 56)
- Change in Total Daily Basal Insulin Dose (U/kg)(Week 0, week 56)
- Change in Total Daily Insulin Dose (U/kg)(Week 0, week 56)
- Change in 7-point SMPG Profile Mean Daytime Glucose Value(Week 0, week 56)
- Change in sBP and dBP(Week 0, week 56)
- Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA(Week 0, week 56)
- Change in SF-36: Sub-domains(Week 0, week 56)
- Participants Losing More Than 10% of Baseline Body Weight at Week 56(Week 56)
- Change in HbA1c(Week 0, week 56)
- Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score(Week 0, week 56)
- Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score(Week 0, week 56)
- Change in Total Daily Insulin Dose (U)(Week 0, week 56)
- Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)(Week 0, week 56)
- Change in SF-36: Physical Component Summary (PCS)(Week 0, week 56)
- Change in SF-36: Mental Component Summary (MCS)(Week 0, week 56)
- Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score(Week 0, week 56)
- Change in IWQoL-Lite for CT: Psychosocial Domain Score(Week 0, week 56)
- Change in IWQoL-Lite for CT: Total Score(Week 0, week 56)
- Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses(Week 0, week 56)
- Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%(Week 56)
- Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia(Week 56)
- Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score(Week 56)
- Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS(Week 56)
- Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS(Week 56)
- Adverse Events (AEs)(Week 0 to week 56 + 30 days)
- Number of Hypoglycaemic Episodes(Week 0 to week 56 + 30 days)
- Change in Physical Examination(Week -1, week 56)
- Change in Resting Pulse(Week -1, week 56)
- Change in Electrocardiogram (ECG)(Week -1, week 56)
- Change in Laboratory Measurements (Haematology) - Haemoglobin(Week 0, week 56)
- Change in Laboratory Measurements (Haematology) - Haematocrit(Week 0, week 56)
- Change in Laboratory Measurements (Haematology) - Erythrocytes(Week 0, week 56)
- Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Albumin(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - eGFR(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Uric Acid(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Calcitonin(Week 0, week 56)
- Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone(Week 0, week 56)
研究者
研究点 (1)
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