Optimal timing of rapid-acting insulin analogues administration before meal - Optimal Lag Time Study
- Conditions
- Diabetes type 1We hypothesize that administration of rapid-acting insulin analogue before the meal will result in better postprandial glucose curves.MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
- Registration Number
- EUCTR2008-005598-36-NL
- Lead Sponsor
- Acedemic Medical Centre Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
Men or women aged from 18 to 75 years
Type 1 diabetes according to the WHO definition
Treated with insulin for at least 2 years and by CSII for at least 6 months
Body mass index (BMI) < 35 kg/m2
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Pregnancy (women of childbearing potential must have an adequate contraception) or breastfeeding
Treatment with systemic corticosteroids
Impaired renal function as shown by serum creatinine = 133 umol/l in men or =124 umol/l in women
Known impaired hepatic function defined as alanine aminotransferase (ALAT) and / or aspart aminotransferase (ASAT) tree times greater the upper limit of the normal range
Alcohol or drug abuse in the last year
Mental condition rendering the patient unable to understand the nature and scope of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method