Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.

The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents

NCT00115570

Diabetes Mellitus, Insulin-Dependent

COMPLETED PHASE3

Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.

NCT01223131

Type 1 Diabetes Mellitus

COMPLETED PHASE3

Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

NCT01349855

Type 1 Diabetes Mellitus

COMPLETED PHASE1

Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

NCT01467141

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE4

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

NCT03740919

Type 1 Diabetes Mellitus

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes.

134 Patients with new onset Diabetes type 1, diagnosed 12 months previously at maximum will be enrolled.

The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with NPH insulin and than 12 weeks with insulin Glargine.

The study will consist of 4 clinical visits, taking place at -2, 0, 12 and 24 weeks. Height,weight,vital signs, HbA1c and insulin doses will be determined during the clinical visits.

Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.

The DTSQ questionnaires consists of DTSQ parents- for patients below the age of 13, and DTSQ teen for those above age 13.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

insulin Glargine + insulin Apidra

Group Type ACTIVE_COMPARATOR

insulin Glargine + Insulin Apidra

Intervention Type DRUG

12 wees treatment with Insulin Glargine + Insulin Apidra

Insulin NPH + Insulin Apidra

12 weeks treatment with Insulin NPH + Insulin Apidra

Group Type ACTIVE_COMPARATOR

Insulin NPH + Insulin Apidra: Active Comparator

Intervention Type DRUG

Insulin NPH + Insulin Apidra: Active Comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin Glargine + Insulin Apidra

12 wees treatment with Insulin Glargine + Insulin Apidra

Intervention Type DRUG

Insulin NPH + Insulin Apidra: Active Comparator

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Type 1 diabetes diagnosed less than 12 months prior to study entry
2. Age: 7-20 years old.
3. HbA1c\>/=8.0
4. Signing inform consent form

Exclusion Criteria

1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study.
2. Patients participating in other device or drug studies.
3. Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.
4. Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.

Minimum Eligible Age

7 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No