Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HbA1C
研究概览
简要总结
An open-label, treat to target, intervention study in order to compare the metabolic control of once to twice-daily insulin Detemir injections in children and adolescence with type 1 diabetes mellitus.
All eligible patients will be assigned to receive insulin Detemir once daily before breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The starting dose of insulin Detemir will be individually determined.Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes would be switched to treatment consist of twice daily insulin Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient will continue until study end on the maintenance phase.
详细描述
An open label,treat to target, prospective, intervention study in order to compare the metabolic control of once to twice-daily insulin detemir injections in children and adolescence with type 1 diabetes mellitus.
Study objectives:
- To assess the efficacy and safety of insulin detemir therapy (once or twice daily) using a treat to target titration protocol for initiating and maintaining therapy in children and adolescents with type 1 diabetes.
- To evaluate the percentage of patients That will achieve a reduction of 0.5% of HbA1c from baseline to end of study evaluation.
- To evaluate Incidence of sever, nocturnal, symptomatic and asymptomatic hypoglycemia and glucose excursions of both hyper and hypoglycemia as measured by the area under the curve determined by the CGMS technique.
Treatment plan:
Patients will be assigned to receive insulin detemir once daily before breakfast. Short acting insulin analog , Novorapid, will be used for mealtime insulin. The starting dose of insulin detemir will be individually determined. Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial related activity
- •Children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
- •Age > 6 years and < 18 years
- •HbA1c > 7.7%
- •Ability and willingness to accept the study conditions and to inject insulin detemir
排除标准
- •Impaired renal function or current renal dialysis.
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- •Known hypoglycemia unawareness.
- •Known or suspected allergy to trial products.
- •Clinical evidence of active liver disease or impaired hepatic function
- •Participation in another study (with study drug) within the last 3 months prior to this trial.
- •Significant concomitant disease likely to interfere with glucose metabolism
- •Proven eating disorders
- •Malignancy within the last 5 years
- •History of repeated severe hypoglycemia within the last year.
- •Known diabetes retinopathy
研究组 & 干预措施
1
once a day
干预措施: Levemir (insulin detemir) (Drug)
2
twice a day
干预措施: Levemir twice a day (Drug)
结局指标
主要结局
HbA1C
时间窗: at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment
SBGM
时间窗: 4-8 times a day
CGMS
时间窗: 72 hours prior to switching to twice daily treatment and at the end of study
Total daily basal and bolus insulin
时间窗: will be calculated every visit
次要结局
- documentation of hypoglycemic and hyperglycemic episodes(diary will be collected every visit)