Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
179 participants
INTERVENTIONAL
2007-05-31
2012-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
HUman Insulin
human insulin /insulin isophane
for subcutaneous injection
2
Analogue insulin
insulin levemir / aspart
for subcutaneous injection
Interventions
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insulin levemir / aspart
for subcutaneous injection
human insulin /insulin isophane
for subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Age\>18 years.
* Two or more episodes of hypoglycaemia during the last year,
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Lise Tarnow
OTHER
Responsible Party
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Lise Tarnow
professor
Principal Investigators
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Lise Tarnow, MD
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center
Gentofte Municipality, , Denmark
Countries
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References
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Pedersen-Bjergaard U, Kristensen PL, Norgaard K, Perrild H, Jensen T, Thorsteinsson B, Nikolajsen A, Tarnow L. Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. Curr Med Res Opin. 2016 Oct;32(10):1719-1725. doi: 10.1080/03007995.2016.1205006. Epub 2016 Jul 20.
Agesen RM, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L, Pedersen-Bjergaard U. Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial. Diabetes Metab. 2016 Sep;42(4):249-55. doi: 10.1016/j.diabet.2016.03.001. Epub 2016 Apr 7.
Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):553-61. doi: 10.1016/S2213-8587(14)70073-7. Epub 2014 May 2.
Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Parving HH, Thorsteinsson B, Tarnow L. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocr Disord. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10.
Other Identifiers
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HypoAna
Identifier Type: -
Identifier Source: org_study_id