Status:
COMPLETED
Insulin Analogues and Severe Hypoglycaemia
Lead Sponsor:
Lise Tarnow
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 ...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- Type 1 diabetes for 5 years.
- Age\>18 years.
- Two or more episodes of hypoglycaemia during the last year,
Exclusion
- History of Addisons disease
- Growth hormone deficiency or untreated myxoedema
- CVD within 6 months
- Cancer within 5 years
- Alcohol or drug abuse
- Pregnant or lactating women
- Fertile women without effective contraception
- Participation in another trial within 30 days
- Inability to understand the informed consent
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00346996
Start Date
May 1 2007
End Date
August 1 2012
Last Update
September 3 2012
Active Locations (1)
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1
Steno Diabetes Center
Gentofte Municipality, Denmark, DK-2820