A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Insulin Detemir-insulin Aspart Cross-reacting Antibodies
研究概览
简要总结
This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 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 procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
- •Finalised 52 weeks of treatment with insulin detemir in trial NN304-
- •Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.
排除标准
- •Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
- •Pregnant or the intention of becoming pregnant.
- •Previous participation in this trial (defined as enrolment).
研究组 & 干预措施
insulin detemir
Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
干预措施: insulin detemir (Drug)
insulin detemir
Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks)
干预措施: insulin aspart (Drug)
结局指标
主要结局
Insulin Detemir-insulin Aspart Cross-reacting Antibodies
时间窗: week 0, 52 and 104
Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.
次要结局
- Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies(At 0, 52 and 104 weeks)
- Glycosylated Haemoglobin A1c (HbA1c)(At 104 weeks)
- Laboratory Values: Creatine Serum Umol/L(At 104 weeks)
- Fasting Plasma Glucose Values(At 104 weeks)
- Hypoglycaemic Episodes(Weeks 0-104)
- BMI (Body Mass Index)(At 104 weeks)
- SD-score (Z-score) for Body Weight(At 104 weeks)
- Diabetic Ketoacidosis(At 104 weeks)
- Insulin Dose(At 104 weeks)
- Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)(At 104 weeks)
- Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)(At 104 weeks)
- Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)(At 104 weeks)
- Laboratory Values: Leukocytes and Thrombocytes(At 104 weeks)
- Fundoscopy/Fundus Photography(at 52 weeks and at 104 weeks)
- Vital Signs: Blood Pressure(At 104 weeks)
- Vital Signs: Pulse(At 104 weeks)