Insulin Analogues and Severe Hypoglycaemia

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lise Tarnow
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 1 diabetes for 5 years.

• Age>18 years.

• Two or more episodes of hypoglycaemia during the last year,

Exclusion Criteria:

• 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