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

NCT00542399 | Completed Phase 4

• 1 other identifier: rmc004543ctil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

levemir; type 1 diabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• documentation of hypoglycemic and hyperglycemic episodes

  diary will be collected every visit

Study Arms (2)

1

EXPERIMENTAL

once a day

Drug: Levemir (insulin detemir)

2

EXPERIMENTAL

twice a day

Drug: Levemir twice a day

Interventions

Levemir (insulin detemir) DRUG

Levemir once a day

1

Levemir twice a day DRUG

Levemir twice a day

2

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent obtained before any trial related activity
• Children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study.
• Age \> 6 years and \< 18 years
• HbA1c \> 7.7%
• Ability and willingness to accept the study conditions and to inject insulin detemir

You may not qualify if:

• Impaired renal function or current renal dialysis.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
• Known hypoglycemia unawareness.
• Known or suspected allergy to trial products.
• Clinical evidence of active liver disease or impaired hepatic function
• Participation in another study (with study drug) within the last 3 months prior to this trial.
• Significant concomitant disease likely to interfere with glucose metabolism
• Proven eating disorders
• Malignancy within the last 5 years
• History of repeated severe hypoglycemia within the last year.
• Known diabetes retinopathy

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

• Nimri R, Lebenthal Y, Shalitin S, Benzaquen H, Demol S, Phillip M. Metabolic control by insulin detemir in basal-bolus therapy: treat-to-target study in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 May;14(3):196-202. doi: 10.1111/pedi.12012. Epub 2013 Jan 4.

  PMID: 23289822 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Moshe Phillip, Professor

  Schneider Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 2, 2011

Record last verified: 2010-07

Locations

IL (1)