The effect of insulin analogues and human insulin on the incidence of severe hypoglycae-mia in hypoglycaemia prone type 1 diabetic patients - HypoAna
- Conditions
- Type 1 diabetes - E10.8MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2006-003630-15-DK
- Lead Sponsor
- Steno Diabetes Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
Male or female aged 18 years
Type 1 diabetes for 5 years or more
Two or more episodes of severe hypoglycaemia during the preceding year
Treated with human insulin or insulin analogues
Willingness to do self monitoring of blood glucose (SMBG)
Negative pregnancy test
Signed 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
History of primary and secondary adrenal insufficiency, growth hormone deficiency, or un-treated myxoedema.
History of major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last six months.
History of malignancy unless a disease free period exceeding five years
History of alcohol or drug abuse
Pregnant or lactating women.
Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
Participation in another investigational drug study within one month
Inability to understand the informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br>;Secondary Objective: Secondary endpoints are effect on incidence of symptomatic and asymptomatic docu-mented hypoglycaemia.;Primary end point(s): The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia from 3 to 12 months of treatment in type 1 diabetic patients prone to hypoglycaemia
- Secondary Outcome Measures
Name Time Method