Metabolic control by insulin detemir in basal-bolus therapy: treat-to-target study in children and adolescents with type 1 diabetes.

Abstract

OBJECTIVE:

To assess the efficacy and safety of insulin detemir administered once vs. twice daily in children and adolescents with type 1 diabetes mellitus.

RESEARCH DESIGN:

In this prospective, open-label, treat-to-target study, 37 patients [mean age 12.7 ± 3 yr; diabetes duration 4.2 ± 3 yr, hemoglobin A1c (HbA1c) 8.8 ± 0.8%] were scheduled to receive insulin detemir once daily before breakfast, with pre-meal insulin aspart, for 16-20 wk. Detemir dose titration algorithm was based on age-related target fasting blood glucose levels during 4-8 wk. Patients achieving target range continued on once-daily detemir (Group A) if up-titration could not be done due to hypoglycemia patients were switched to twice-daily detemir (Group B).

RESULTS:

Nineteen (51%) patients continued with once-daily detemir. HbA1c decreased significantly in both groups (A: -0.7%, p = 0.02; B: -0.8%, p = 0.004), without a significant difference between groups. The frequency of nocturnal hypoglycemic events/week decreased in both groups but a significant change was found only in Group A (10.9-2.7, p < 0.05 vs. 8.7-5.8, NS), with no change in frequency of severe hypoglycemic episodes in either group. No significant differences were found between and within groups for body mass index-standard deviation score, insulin requirement or treatment satisfaction. Group B patients were significantly younger than Group A patients (11.5 ± 2.3 vs.13.8 ± 3.2 yr, p = 0.01), with a higher percentage in active puberty (50 vs. 11%, p = 0.003).

CONCLUSION:

Since twice-daily determir showed no clinical advantage over once-daily detemir, it appears reasonable to commence all children on once-daily detemir, taking into consideration that younger children and those in active puberty may require twice-daily therapy (ClinicalTrials.gov number, NCT00542399).

• Authors: Revital Nimri, Yael Lebenthal, Shlomit Shalitin, Hadasa Benzaquen, Sharon Demol, Moshe Phillip
• Journal: Pediatric diabetes (Pediatr Diabetes) Vol. 14 Issue 3 Pg. 196-202 (May 2013) ISSN: 1399-5448 [Electronic] Denmark
• PMID: 23289822 (Publication Type: Clinical Trial, Comparative Study, Journal Article)
• Copyright: © 2013 John Wiley & Sons A/S.

Chemical References

• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin, Long-Acting
• hemoglobin A1c protein, human
• Insulin Detemir
• Insulin Aspart

Topics

• Adolescent
• Algorithms
• Child
• Cohort Studies
• Diabetes Mellitus, Type 1 (blood, drug therapy)
• Drug Administration Schedule
• Drug Monitoring
• Drug Therapy, Combination (adverse effects)
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (epidemiology, prevention & control)
• Hypoglycemia (epidemiology, prevention & control)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• Incidence
• Insulin Aspart (administration & dosage, adverse effects, therapeutic use)
• Insulin Detemir
• Insulin, Long-Acting (administration & dosage, adverse effects, therapeutic use)
• Israel (epidemiology)
• Male