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Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00542399
First received: October 10, 2007
Last updated: November 1, 2011
Last verified: July 2010
History of Changes
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • HbA1C [ Time Frame: at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment ] [ Designated as safety issue: No ]
  • SBGM [ Time Frame: 4-8 times a day ] [ Designated as safety issue: No ]
  • CGMS [ Time Frame: 72 hours prior to switching to twice daily treatment and at the end of study ] [ Designated as safety issue: No ]
  • Total daily basal and bolus insulin [ Time Frame: will be calculated every visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • documentation of hypoglycemic and hyperglycemic episodes [ Time Frame: diary will be collected every visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2007
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
once a day
 Drug: Levemir (insulin detemir)
Levemir once a day
Experimental: 2
twice a day
 Drug: Levemir twice a day
Levemir twice a day

Detailed Description:

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:

  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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained before any trial related activity
  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:

  1. Impaired renal function or current renal dialysis.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542399

Locations
Israel
Schneider Children's Medical Center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center
  More Information

No publications provided by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00542399     History of Changes
Other Study ID Numbers: rmc004543ctil
Study First Received: October 10, 2007
Last Updated: November 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
levemir
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013