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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542399
• Other study ID #: rmc004543ctil
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2007
• Last updated: November 1, 2011
• Start date: November 2007
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Levemir (insulin detemir)
Levemir once a day
• Levemir twice a day
Levemir twice a day

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment	No
Primary	SBGM		4-8 times a day	No
Primary	CGMS		72 hours prior to switching to twice daily treatment and at the end of study	No
Primary	Total daily basal and bolus insulin		will be calculated every visit	No
Secondary	documentation of hypoglycemic and hyperglycemic episodes		diary will be collected every visit	Yes