Insulin Analogues and Severe Hypoglycaemia
|Type 1 Diabetes||Drug: insulin levemir / aspart Drug: human insulin /insulin isophane||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients|
- Severe hypoglycaemia [ Time Frame: 9 months ]
- asymptomatic hypoglycaemia [ Time Frame: 9 months ]
- hypoglycaemia during nighttime [ Time Frame: 9 months ]
- hypoglycaemia during daytime [ Time Frame: 9 months ]
|Study Start Date:||May 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Drug: human insulin /insulin isophane
for subcutaneous injection
Drug: insulin levemir / aspart
for subcutaneous injection
The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.
Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.
Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.
Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.
Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.
Outcomes: Severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia Efficacy: Number of reported episodes of severe, documented symptomatic and asymptomatic hypoglycaemia during the last 9 months of treatment - during daytime and night time.
Safety: Adverse reactions
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346996
|Steno Diabetes Center|
|Gentofte, Denmark, DK-2820|
|Principal Investigator:||Lise Tarnow, MD||Steno Diabetes Center|