NCT00612040已完成2 期
A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least one year
- •HbA1c 7-11% (both inclusive)
- •Treated with insulin for at least six months - any regimen
排除标准
- •Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
- •Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product
研究组 & 干预措施
SIBA (D)
Experimental
干预措施: insulin degludec (Drug)
SIBA (D)
Experimental
干预措施: insulin aspart (Drug)
SIBA (E)
Experimental
干预措施: insulin degludec (Drug)
SIBA (E)
Experimental
干预措施: insulin aspart (Drug)
IGlar
Experimental
干预措施: insulin glargine (Drug)
IGlar
Experimental
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 16
Change from baseline in HbA1c after 16 weeks of treatment
次要结局
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 16)
- Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)(Week 16)
- Rate of Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
- Rate of Nocturnal Major and Minor Hypoglycaemic Episodes(Week 0 to Week 16 + 5 days follow up)
- Rate of Treatment Emergent Adverse Events (AEs)(Week 0 to Week 16 + 5 days follow up)
- Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)(Week -1, Week 16)
- Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)(Week -1, Week 16)
- Laboratory Safety Parameters (Biochemistry): Serum Creatinine(Week -1, Week 16)
- Vital Signs: Diastolic BP (Blood Pressure)(Week 0, Week 16)
- Vital Signs: Systolic BP (Blood Pressure)(Week 0, Week 16)
- Vital Signs: Pulse(Week 0, Week 16)
- Physical Examination(Week -1, Week 8, Week 16)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00909480Novo Nordisk A/S457
已完成
4 期
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and MetforminDiabetesDiabetes Mellitus, Type 2NCT01519674Novo Nordisk A/S582
已完成
3 期
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia BCongenital Bleeding DisorderHaemophilia BNCT01386528Novo Nordisk A/S13
已完成
3 期
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725Congenital Bleeding DisorderCongenital FXIII DeficiencyNCT00978380Novo Nordisk A/S63
已完成
3 期
A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes MellitusDiabetesDiabetes Mellitus, Type 1NCT01513473Novo Nordisk A/S350