Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents
概览
- 阶段
- 4 期
- 干预措施
- NPH insulin
- 疾病 / 适应症
- Diabetes Mellitus Type 1
- 发起方
- Karolinska Institutet
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HbA1c
- 最后更新
- 15年前
概览
简要总结
Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.
This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.
研究者
入排标准
入选标准
- •Diagnosis of diabetes and novel to insulin therapy
- •Age 7 - 17 years
- •Informed consent
排除标准
- •Moderate to severe ketoacidosis (pH\<7.2 and/or standard bicarbonate \<10 mmol/l)
- •Suspected non-type 1
- •IA2 and GAD65: all-antibody negative
- •Celiac disease or other chronic disease
- •Hypothyroidism, if not well controlled
- •Syndromes
- •Previous anorexia nervosa
- •Neuro-psychiatric disease
- •Malignancy
研究组 & 干预措施
Insulatard
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars
干预措施: NPH insulin
Lantus
Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
干预措施: Glargine
Levemir
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
干预措施: Detemir
结局指标
主要结局
HbA1c
时间窗: 1 year
The study compare HbA1c one year after start of treatment at diagnosis of T1DM in patients treated with Lantus or Levemir with patients treated with Insulatard.
次要结局
- Stimulated C-peptide(2 weeks and 3, 6 and 12 month)
- IGF-I(diagnosis, 2 weeks, 3,6,9 and 12 month)