Type 1 diabetes mellitus, dawn phenomenon
Conditions
Interventions
Trade Name: Levemir
Pharmaceutical Form: Injection*
Trade Name: NovoRapid Penfill
Pharmaceutical Form: Injection*
Trade Name: Insulatard Penfill
Pharmaceutical Form: Injection*
Trade Name: NovoRap
Sponsors
National Centre for Diabetes Care, 1st Dept. Medicine, Diabetes Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with type 1 diabetes mellitus • Subjects ==65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate that the effect of insulin detemir on fasting blood glucose between 5.00 am. – 6.30 am. is superior compared to insulin NPH in Type 1 patients with dawn phenomenon.;Secondary Objective: • To compare the incidence of hypoglycaemic episodes during treatment with insulin aspart (IAsp) / Detemir and IAsp / NPH. • To compare the safety profiles of IAsp / Detemir with IAsp / NPH as measured by the occurrence of adverse events during treatment. • To compare the safety profiles of IAsp / Detemir with IAsp / NPH as measured by standard safety parameters (haematology and biochemistry). • To compare the Quality of Life during treatment with IAsp / Detemir and IAsp / NPH. • To compare glycaemic control as measured by HbA1c and blood glucose excursions in patients having dawn phenomenon. • To compare the effect of the Detemir administration at morning and bedtime versus at 12 hours intervals both with mealtime IAsp on the blood glucose rise in the early morning hours. • To evaluate changes in total daily insulin dose, basal insulin dose and the bolus / basal ratio.;Primary end point(s): Changes in early morning glycaemic control (measured as mean FPG, difference between fasting and bedtime values, difference between fasting and 03:00 values) | — |
Countries
Hungary
Outcome results
None listed