Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
NCT ID: NCT00184600
Last Updated: 2017-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
708 participants
INTERVENTIONAL
2004-11-30
2009-08-31
Brief Summary
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The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin detemir (basal insulin)
Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen.
insulin detemir
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Insulin aspart (prandial insulin)
Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen.
biphasic insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Biphasic insulin aspart 30 (biphasic insulin)
Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.
insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
Interventions
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biphasic insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
insulin detemir
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
Eligibility Criteria
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Inclusion Criteria
* Insulin naive
* On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
* Body Mass Index (BMI) below or equal to 40.0 kg/m2
* HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
Exclusion Criteria
* Recurrent major hypoglycaemia
* Cardial problems
* Uncontrolled hypertension
* Impaired hepatic or renal function
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
Dublin, , Ireland
Novo Nordisk Investigational Site
Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Aberdeen, , United Kingdom
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Addlestone, , United Kingdom
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Airdrie, , United Kingdom
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Ashton-under-Lyne, , United Kingdom
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Ayr, , United Kingdom
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Belfast, , United Kingdom
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Belfast, , United Kingdom
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Belfast, , United Kingdom
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Berkshire, , United Kingdom
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Bournemouth, , United Kingdom
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Bradford, , United Kingdom
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Bristol, , United Kingdom
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Bury St Edmunds, , United Kingdom
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Cambridge, , United Kingdom
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Colchester, , United Kingdom
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Coventry, , United Kingdom
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Crawley, , United Kingdom
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Derby, , United Kingdom
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Dundee, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Gillingham, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Haywards Heath, , United Kingdom
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Headington, , United Kingdom
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High Wycombe, , United Kingdom
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Hull, , United Kingdom
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Kettering, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Liverpool, , United Kingdom
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Livingstone, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Middlesbrough, , United Kingdom
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Newcastle, , United Kingdom
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Newcastle, , United Kingdom
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Norfolk, , United Kingdom
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Northampton, , United Kingdom
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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
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Rugby, , United Kingdom
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Sheffield, , United Kingdom
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Skipton, , United Kingdom
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Stevenage, , United Kingdom
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Torquay, , United Kingdom
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Welwyn Garden City, , United Kingdom
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Whiston, , United Kingdom
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Wirral, Merseyside, , United Kingdom
Countries
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References
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Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22.
Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007 Oct 25;357(17):1716-30. doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.
Jenkins N, Hallowell N, Farmer AJ, Holman RR, Lawton J. Participants' experiences of intensifying insulin therapy during the Treating to Target in Type 2 Diabetes (4-T) trial: qualitative interview study. Diabet Med. 2011 May;28(5):543-8. doi: 10.1111/j.1464-5491.2010.03200.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2004-000514-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1613
Identifier Type: -
Identifier Source: org_study_id
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