The effect of insulin analogues and human insulin on the incidence of severe hypoglycae-mia in hypoglycaemia prone type 1 diabetic patients - HypoAna

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003630-15-DK

Enrollment

370

Registered

2007-01-24

Start date

2007-03-06

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes - E10.8 MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: Levemir Pharmaceutical Form: Injection* INN or Proposed INN: insulin detemir Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. ;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	—

Measure

Time frame

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. ;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

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026