Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes
NCT ID: NCT00509925
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
23 participants
INTERVENTIONAL
2007-07-31
2008-07-31
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
NONE
Study Groups
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Treatment period 1
Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Treatment period 2
Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart
insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Interventions
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insulin detemir
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin NPH
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
insulin aspart
Treat-to-target dose tritation (dose adjusted individually), s.c. (under the skin) injection
Eligibility Criteria
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Inclusion Criteria
* Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal)
* HbA1c (glycosylated haemoglobin A1c) between 7.0 and 11.0%
* Able and willing to maintain consistent physical activity level throughout the entire study period
* Able and willing to maintain consistent eating habits throughout the entire study period
Exclusion Criteria
* Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
* Liver, kidney or heart problems as judged by the Investigator
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
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
Guildford, , United Kingdom
Countries
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References
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Zachariah S, Sheldon B, Shojaee-Moradie F, Jackson NC, Backhouse K, Johnsen S, Jones RH, Umpleby AM, Russell-Jones DL. Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. Diabetes Care. 2011 Jul;34(7):1487-91. doi: 10.2337/dc11-0098. Epub 2011 May 18.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-003060-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1761
Identifier Type: -
Identifier Source: org_study_id
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