Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
NCT ID: NCT00537303
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
296 participants
INTERVENTIONAL
2007-10-31
2009-03-31
Brief Summary
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The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.
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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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Advanced
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
insulin aspart
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
Basic
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
Interventions
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insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
insulin aspart
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
Eligibility Criteria
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Inclusion Criteria
* HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
* BMI (Body Mass Index) less than 40 kg/m2
* Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
* Treatment with one to 3 OADs
Exclusion Criteria
* Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
* Previous participation in any trial including this for the last 6 months
* Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
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
Fresno, California, United States
Novo Nordisk Investigational Site
Mission Viejo, California, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Des Moines, Iowa, United States
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Lawrenceville, New Jersey, United States
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Asheville, North Carolina, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Greer, South Carolina, United States
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Chattanooga, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Milwaukee, Wisconsin, United States
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Århus C, , Denmark
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Espoo, , Finland
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Oulu, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Vaasa, , Finland
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Vantaa, , Finland
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Le Creusot, , France
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Nanterre, , France
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Narbonne, , France
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Pointe à Pitre, , France
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Vénissieux, , France
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's-Hertogenbosch, , Netherlands
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Eindhoven, , Netherlands
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Etten-Leur, , Netherlands
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Hulst, , Netherlands
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Utrecht, , Netherlands
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Woerden, , Netherlands
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Jessheim, , Norway
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Oslo, , Norway
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Sarpsborg, , Norway
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Stavanger, , Norway
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Tromsø, , Norway
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Tønsberg, , Norway
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Belgrade, , Serbia and Montenegro
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Nis, , Serbia and Montenegro
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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Cáceres, , Spain
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Inca, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Mostoles - Madrid -, , Spain
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Santiago de Compostela, , Spain
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Ängelholm, , Sweden
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Gothenburg, , Sweden
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Mölndal, , Sweden
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Aberdeen, , United Kingdom
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Coventry, , United Kingdom
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Livingstone, , United Kingdom
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Llanelli, , United Kingdom
Novo Nordisk Investigational Site
Llantrisant, , United Kingdom
Novo Nordisk Investigational Site
Reading, , United Kingdom
Novo Nordisk Investigational Site
Rugby, , United Kingdom
Countries
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References
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Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-000123-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1833
Identifier Type: -
Identifier Source: org_study_id
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