Comparison of the effect of insulin detemir and NPH insulin on dawn phenomenon in patients with Type 1 diabetes An open-labelled, randomised, cross-over, multi-center trial comparing the effect of insulin detemir versus NPH insulin as basal insulins on dawn phenomenon and the glycaemic control in patients with Type 1 diabetes treated on a basal-bolus regimen - Dawn phenomenon – insulin detemir
- Conditions
- Type 1 diabetes mellitus, dawn phenomenon
- Registration Number
- EUCTR2005-003877-26-HU
- Lead Sponsor
- ational Centre for Diabetes Care, 1st Dept. Medicine, Diabetes Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Subjects with type 1 diabetes mellitus
•Subjects =< 35 years of age at diagnosis
•Currently on basal-bolus treatment with any basal and bolus insulins (start of insulin therapy within 1 year after diagnosis)
•Age between 18 and 60 years (both inclusive)
•Verified dawn phenomenon
•BMI =< 35.0 kg/m2
•HbA1c between 7.0 and 10.0% (both inclusive)
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) no
F.1.3.1 Number of subjects for this age range
•Subjects with proliferative retinopathy or maculopathy requiring acute treatment within the last 6 months
•Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and mono amine oxidase (MAO) inhibitors
•Impaired hepatic or renal function that according to the Investigator will interfere with trial participation
•Known or suspected allergy to trial products or related products
•Previously screened in this trial
•Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
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