A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bolus Regimen With Insulin Aspart as the Bolus Insulin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 主要终点
- Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
研究概览
简要总结
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.
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
- •Type 1 diabetes for at least 12 months
- •Basal-bolus treatment for at least 3 months
- •Body Mass Index (BMI) less than or equal to 35.0 kg/m^2
- •HbA1c (glycosylated haemoglobin) less than or equal to 12.0%
排除标准
- •Known or suspected allergy to trial products or related products
- •Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
- •Receipt of any trial drug within 1 month prior to this trial
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
研究组 & 干预措施
NN304
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
干预措施: insulin detemir (Drug)
NN304
Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
干预措施: insulin aspart (Drug)
NN729
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
干预措施: insulin aspart (Drug)
NN729
Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
干预措施: insulin detemir (Drug)
结局指标
主要结局
Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
时间窗: week 0, week 52
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
次要结局
- Glycaemic Control Parameters (Change in HbA1c)(week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Albumin)(Week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Haemoglobin)(Week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Lymphocytes)(Week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Neutrophils)(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Potassium)(Week 0, week 52)
- Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])(week 0, week 52)
- Change From Baseline in Detemir Specific Antibodies(Week 0, week 52)
- Change From Baseline in Total Antibodies(Week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Leucocytes)(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Creatinine)(Week 0, week 52)
- Hypoglycaemic Episodes(Weeks 0-52)
- Clinical Laboratory Values (Change in Haematology - Eosinophils)(Week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Monocytes)(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])(Week 0, week 52)
- Clinical Laboratory Values (Change in Biochemistry - Total Protein)(Week 0, week 52)
- Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])(week 0, 26 and 52)
- Clinical Laboratory Values (Change in Haematology - Basophilis)(week 0, week 52)
- Clinical Laboratory Values (Change in Haematology - Thrombocytes)(Week 0, week 52)
- Adverse Events(Weeks 0-52)
- Clinical Laboratory Values (Change in Biochemistry - Sodium)(Week 0, week 52)