Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Rabin Medical Center |
---|---|
Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00542399 |
An open-label, treat to target, intervention study in order to compare the metabolic control of once to twice-daily insulin Detemir injections in children and adolescence with type 1 diabetes mellitus.
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.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes Mellitus |
Drug: Levemir (insulin detemir) Drug: Levemir twice a day |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Comparing the Metabolic Control of Once to Twice-Daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus. |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
once a day
|
Drug: Levemir (insulin detemir)
Levemir once a day
|
2: Experimental
twice a day
|
Drug: Levemir twice a day
Levemir twice a day
|
An open label,treat to target, prospective, intervention study in order to compare the metabolic control of once to twice-daily insulin detemir injections in children and adolescence with type 1 diabetes mellitus.
Study objectives:
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.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Moshe Phillip, Prof. | 03-9253778 | mosheph@clalit.org.il |
Israel | |
Schneider Children's Medical Center | Recruiting |
Petach-Tikva, Israel | |
Contact: Moshe Phillip, Professor 03-9253778 mosheph@clalit.org.il | |
Principal Investigator: Moshe Phillip, Prof | |
Sub-Investigator: Tal Oron, Dr. | |
Sub-Investigator: Sharon Demol, Dr. | |
Sub-Investigator: Liora Lazar, Dr. | |
Sub-Investigator: Liat De Vreis, Dr. | |
Sub-Investigator: Rachel Frumkin, Dr. | |
Sub-Investigator: Shlomit Shalitin, DR. | |
Sub-Investigator: Yael Levental, DR. | |
Sub-Investigator: Ariel Tenenbaum, Dr. | |
Sub-Investigator: Ravital Nimri, Dr. | |
Sub-Investigator: Neomi Weintrob, Dr. |
Principal Investigator: | Moshe Phillip, Professor | Schneider Children Medical Center |
Responsible Party: | Rabim Medical Center ( Prof. Moshe Phillip ) |
Study ID Numbers: | rmc004543ctil |
Study First Received: | October 10, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00542399 |
Health Authority: | Israel: Ministry of Health |
levemir type 1 diabetes |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |