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Sponsors and Collaborators: |
Steno Diabetes Center Novo Nordisk |
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Information provided by: | Steno Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00346996 |
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
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes |
Drug: insulin levemir / aspart Drug: human insulin /insulin isophane |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients |
Estimated Enrollment: | 370 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
HUman Insulin
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Drug: human insulin /insulin isophane
for subcutaneous injection
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2: Experimental
Analogue insulin
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Drug: insulin levemir / aspart
for subcutaneous injection
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lise Tarnow, md | +45 44 43 99 52 | ltar@steno.dk |
Contact: Hans-Henrik Parving, MD | +45 22 17 81 60 | hhparving@dadlnet.dk |
Denmark | |
Steno Diabetes Center | Recruiting |
Gentofte, Denmark, DK-2820 | |
Contact: lise Tarnow, md | |
Principal Investigator: Lise Tarnow, MD |
Principal Investigator: | Lise Tarnow, MD | Steno Diabetes Center |
Responsible Party: | Steno Diabetes Center ( Lise Tarnow ) |
Study ID Numbers: | HypoAna |
Study First Received: | June 30, 2006 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00346996 |
Health Authority: | Denmark: Danish Medicines Agency |
diabetes insulin insulin analogues hypoglycaemia severe hypoglycaemia |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases Endocrinopathy |
Metabolic disorder Glucose Metabolism Disorders Hypoglycemia Insulin, Isophane Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |