Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
NCT ID: NCT00542399
Last Updated: 2011-11-02
Study Results
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Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2007-11-30
2010-03-31
Brief Summary
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All eligible patients will be assigned to receive insulin Detemir once daily before breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The starting dose of insulin Detemir will be individually determined.Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes would be switched to treatment consist of twice daily insulin Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient will continue until study end on the maintenance phase.
Detailed Description
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Study objectives:
1. To assess the efficacy and safety of insulin detemir therapy (once or twice daily) using a treat to target titration protocol for initiating and maintaining therapy in children and adolescents with type 1 diabetes.
2. To evaluate the percentage of patients That will achieve a reduction of 0.5% of HbA1c from baseline to end of study evaluation.
3. To evaluate Incidence of sever, nocturnal, symptomatic and asymptomatic hypoglycemia and glucose excursions of both hyper and hypoglycemia as measured by the area under the curve determined by the CGMS technique.
Treatment plan:
Patients will be assigned to receive insulin detemir once daily before breakfast. Short acting insulin analog , Novorapid, will be used for mealtime insulin. The starting dose of insulin detemir will be individually determined. Based on self-measured fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at pre breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for subjects aged 13-18 years.
Patients that after 4 weeks titration phase will not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due to hypoglycemic episodes, would be switched to treatment consist of twice daily insulin Detemir.
If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but further up titration is possible and patient does not suffer from hypoglycemic episodes, the titration period would be extended and patient would not be switched to treatment with 2 injections of insulin Detemir.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
once a day
Levemir (insulin detemir)
Levemir once a day
2
twice a day
Levemir twice a day
Levemir twice a day
Interventions
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Levemir (insulin detemir)
Levemir once a day
Levemir twice a day
Levemir twice a day
Eligibility Criteria
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Inclusion Criteria
2. Children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
3. Age \> 6 years and \< 18 years
4. HbA1c \> 7.7%
5. Ability and willingness to accept the study conditions and to inject insulin detemir
Exclusion Criteria
2. Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
3. Known hypoglycemia unawareness.
4. Known or suspected allergy to trial products.
5. Clinical evidence of active liver disease or impaired hepatic function
6. Participation in another study (with study drug) within the last 3 months prior to this trial.
7. Significant concomitant disease likely to interfere with glucose metabolism
8. Proven eating disorders
9. Malignancy within the last 5 years
10. History of repeated severe hypoglycemia within the last year.
11. Known diabetes retinopathy
6 Years
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Professor
Role: PRINCIPAL_INVESTIGATOR
Schneider Children Medical Center
Locations
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Schneider Children's Medical Center
Petah Tikva, , Israel
Countries
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References
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Nimri R, Lebenthal Y, Shalitin S, Benzaquen H, Demol S, Phillip M. Metabolic control by insulin detemir in basal-bolus therapy: treat-to-target study in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 May;14(3):196-202. doi: 10.1111/pedi.12012. Epub 2013 Jan 4.
Other Identifiers
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rmc004543ctil
Identifier Type: -
Identifier Source: org_study_id