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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Levemir (insulin detemir); Drug: Levemir twice a day

• Registration Number: NCT00542399
• Lead Sponsor: Rabin Medical Center

Brief 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.

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.

Study Timeline

• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Study Start: 2007-11
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2010-07
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Levemir (insulin detemir)	once a day
2	Levemir twice a day	twice a day

Primary Outcome Measures

Name	Time	Method
HbA1C	at screening visit, at the middle of the study, at the end of the study and prior to sweetching to twice daily treatment
SBGM	4-8 times a day
CGMS	72 hours prior to switching to twice daily treatment and at the end of study
Total daily basal and bolus insulin	will be calculated every visit

Secondary Outcome Measures

Name	Time	Method
documentation of hypoglycemic and hyperglycemic episodes	diary will be collected every visit

Trial Locations

Locations (1)

Schneider Children's Medical Center; 🇮🇱 Petach-Tikva, Israel