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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00542399
• Date of registration: 10/10/2007
• Prospective Registration: Yes
• Primary sponsor: Rabin Medical Center
• Public title: Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
• Scientific title: Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections in Children and Adolescence With Type 1 Diabetes Mellitus.
• Date of first enrolment: November 2007
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00542399
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Israel

Contacts

• Name: Moshe Phillip, Professor
• Affiliation: Schneider Children Medical Center

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Drug: Levemir twice a day

Drug: Levemir (insulin detemir)

Primary Outcome(s)

CGMS [Time Frame: 72 hours prior to switching to twice daily treatment and at the end of study]

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]

Total daily basal and bolus insulin [Time Frame: will be calculated every visit]

SBGM [Time Frame: 4-8 times a day]

Secondary Outcome(s)

documentation of hypoglycemic and hyperglycemic episodes [Time Frame: diary will be collected every visit]

Secondary ID(s)

rmc004543ctil

Source(s) of Monetary Support

Please refer to primary and secondary sponsors