The Effect of Rapid-acting Insulin Injected by Needle-free Jet-injection in the Management of Hyperglycemia in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- T-BG≥10
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes
详细描述
Recently, we showed in both healthy, non-diabetic volunteers and in patients with type 1 (T1DM) and insulin-treated type 2 diabetes (T2DM) a 40-50% faster absorption of rapid-acting insulin analogues when administered by jet injection technology rather than by conventional insulin pen. The faster insulin action of insulin administration by jet injection may be especially advantageous for correction of hyperglycemia.
To investigate this, a open-label randomised controlled cross-over study will be performed in 20 adult patients (18-75 years) with T1DM or T2DM on basal-bolus insulin treatment.
The pharmacokinetic and pharmacodynamic profile of insulin aspart will be derived from the time-action profiles of insulin and glucose, respectively, in response to insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) after reaching hyperglycemia (18-23 mmol/l). All patients will be investigated twice, where on one occasion the jet-injector device will be used to inject insulin, and on the other occasion insulin will be injected with a conventional insulin pen. The order of these occasions will be randomised. Both devices will be operated by the patient after sufficient training. Ease of use will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •diabetes mellitus type 1 or 2
- •Age 18-75 years
- •Body-Mass Index ≥25 kg/m2 and ≤40 kg/m2
- •Stable glycaemic control with HbA1c ≥48 (6.5%) and ≤86 mmol/mol (10%)
- •Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed
排除标准
- •Inability to provide informed consent
- •Insulin requirement of <34 or >200 units per day
- •Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
- •Known allergy to aspart insulin
- •Use of oral antidiabetic drugs other than metformin
- •Symptomatic diabetic neuropathy
- •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
- •Pregnancy or the intention to become pregnant
- •Renal disease (creatinine >150 μmol/l or MDRD-GFR <30 ml/min/1.73m2)
- •Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
- •Presence of any other medical condition that might interfere with the study protocol
研究组 & 干预措施
insujet is tested first
first procedure: experiment with the investigational product (Insujet pen)containing insulin aspart; second procedure: control device (conventional Novopen III insulin pen) contains insulin aspart.
干预措施: insulin aspart (Drug)
insujet is tested second
first procedure: experiment with the conventional Novopen III insulin pen containing insulin aspart; second procedure: investigational device (Insujet) contains insulin aspart.
干预措施: insulin aspart (Drug)
结局指标
主要结局
T-BG≥10
时间窗: participants will be followed for the duration of the study, an expected average of 4 weeks
the time in minutes until plasma glucose concentration has dropped with ≥ 10mmol/l (T-BG≥10).
次要结局
- T-BG5 and 8 (min)(participants will be followed for the duration of the study, an expected average of 4 weeks)
- Rfall(participants will be followed for the duration of the study, an expected average of 4 weeks)
- BG-AUC 0-2h(participants will be followed for the duration of the study, an expected average of 4 weeks)
- BG-AUC 0-6h(participants will be followed for the duration of the study, an expected average of 4 weeks)
- C-INSmax (pmol/l)(participants will be followed for the duration of the study, an expected average of 4 weeks)
- T-INSmax(participants will be followed for the duration of the study, an expected average of 4 weeks)
- T-INSBL(participants will be followed for the duration of the study, an expected average of 4 weeks)
- INSAUC(participants will be followed for the duration of the study, an expected average of 4 weeks)
- T-INSAUC50%(participants will be followed for the duration of the study, an expected average of 4 weeks)
研究者
HM de Wit
MD
University Medical Center Nijmegen