Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT ID: NCT01487798
Last Updated: 2017-01-06
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
170 participants
INTERVENTIONAL
2002-06-30
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment period 1
biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Treatment period 2
biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Interventions
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biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Eligibility Criteria
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Inclusion Criteria
* Treated with insulin 1-3 injections daily for at least 6 months
* Body Mass Index (BMI) below 40 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening
Exclusion Criteria
* Impaired hepatic or renal function or significant cardiac problems
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Bolton, , United Kingdom
Novo Nordisk Investigational Site
Cardiff, , United Kingdom
Novo Nordisk Investigational Site
Derby, , United Kingdom
Novo Nordisk Investigational Site
Dundee, , United Kingdom
Novo Nordisk Investigational Site
Exeter, , United Kingdom
Novo Nordisk Investigational Site
Galway, , United Kingdom
Novo Nordisk Investigational Site
Glasgow, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
Liverpool, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Newcastle, , United Kingdom
Novo Nordisk Investigational Site
Nottingham, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Upton, , United Kingdom
Novo Nordisk Investigational Site
Wirral, Merseyside, , United Kingdom
Novo Nordisk Investigational Site
York, , United Kingdom
Countries
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References
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McNally PG, Dean JD, Morris AD, Wilkinson PD, Compion G, Heller SR. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care. 2007 May;30(5):1044-8. doi: 10.2337/dc06-1328. Epub 2007 Feb 2.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1466
Identifier Type: -
Identifier Source: org_study_id
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