NCT02501161已完成3 期
A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
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
- 1,012
- 试验地点
- 1
- 主要终点
- Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.
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 greater than or equal to 18 years at the time of signing informed consent
- •Subjects diagnosed with type 2 diabetes mellitus
- •HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
- •Body mass index greater than or equal to 20 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 is prior insulin treatment for gestational diabetes
- •Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)
排除标准
- •Screening calcitonin greater than or equal to 50 ng/L
- •Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
- •Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
- •History of pancreatitis (acute or chronic)
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
- •Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
研究组 & 干预措施
Insulin degludec/liraglutide QD + OAD(s)
Experimental
干预措施: insulin degludec/liraglutide (Drug)
insulin glargine QD + OAD(s)
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification
时间窗: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.
次要结局
- Insulin Dose(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c <7.0%(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c ≤6.5%(Week 26, week 104)
- Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits(Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2)
- Change in HbA1c(Week 0, week 26)
- Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain(Week 26, week 104)
- Change in Body Weight(Week 0, week 26, week 104)
- Change in Fasting Triglycerides(Week 0, week 26, week 104)
- Change in Fasting Free Fatty Acids(Week 0, week 26, week 104)
- Change in SMPG-mean 9-point Profile(Week 0, week 26, week 104)
- Change in SMPG-mean Postprandial Increment Over All Meals(Week 0, week 26, week 104)
- Change in Blood Pressure (Systolic and Diastolic)(Week 0, week 26, week 104)
- Change in Fasting C-peptide(Week 0, week 26, week 104)
- Change in Fasting Human Insulin(Week 0, week 26, week 104)
- Change in Fasting Total Cholesterol(Week 0, week 26, week 104)
- Change in Fasting LDL-cholesterol(Week 0, week 26, week 104)
- Change in Fasting HDL-cholesterol(Week 0, week 26, week 104)
- Change in Fasting VLDL-cholesterol(Week 0, week 26, week 104)
- Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment(Weeks 0-26)
- Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment(Weeks 0-104)
- Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment(Weeks 0-26)
- Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment(Weeks 0-104)
- Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment(Weeks 0-26)
- Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment(Weeks 0-104)
- Number of TEAEs During 26 Weeks of Treatment(Weeks 0-26)
- Number of TEAEs During 104 Weeks of Treatment(Week 0 to week 104)
- Eye Examination Category(Baseline (within 12 weeks prior to week 0), week 104)
- ECG Evaluation(Baseline (within 2 weeks prior to week 0), week 104)
- Change in Urine Albumin/Creatinine Ratio(Week 0, week 104)
- Change in Pulse Rate(Week 0, week 26, week 104)
- Change in Biochemistry Parameter- Creatinine, Total Bilirubin(Week 0, week 26, week 104)
- Change in Biochemistry Parameter- Albumin(Week 0, week 26, week 104)
- Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase(Week 0, week 26, week 104)
- Change in Biochemistry Parameter- Sodium, Potassium and Calcium(Week 0, week 26, week 104)
- Change in Haematological Parameter- Haemoglobin(Week 0, week 26, week 104)
- Change in Haematological Parameter- Haematocrit(Week 0, week 26, week 104)
- Change in Haematological Parameter- Erythrocytes(Week 0, week 26, week 104)
- Change in Haematological Parameter- Thrombocytes and Leukocytes(Week 0, week 26, week 104)
- Change in Haematological Parameter- Neutrophils(Week 0, week 26, week 104)
- Change in Haematological Parameter- Eosinophils(Week 0, week 26, week 104)
- Change in Haematological Parameter- Basophils(Week 0, week 26, week 104)
- Change in Haematological Parameter- Monocytes(Week 0, week 26, week 104)
- Change in Haematological Parameter- Lymphocytes(Week 0, week 26, week 104)
- Change in Calcitonin(Week 0, week 26, week 104)
- Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)(Week 0, week 26, week 104)
- Change in TRIM-D(Week 0, week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain(Week 26, week 104)
- Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain(Week 26, week 104)
- Change in FPG(Week 0, week 26, week 104)
- SMPG-9-point Profile (Individual Points in the Profile)(Week 26, week 104)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01486940Novo Nordisk A/S598
已完成
3 期
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01513590Novo Nordisk A/S394
已完成
3 期
The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02098395Novo Nordisk A/S835
已完成
2 期
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00611884Novo Nordisk A/S245
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 MellitusDiabetesDiabetes Mellitus, Type 2NCT02773368Novo Nordisk A/S420