Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Type 1 |
Drug: insulin Glargine + Insulin Apidra Drug: Insulin NPH + Insulin Apidra: Active Comparator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents |
- Treatment satisfaction [ Time Frame: patients will complete DTSQ at months 0,12 and 24 ] [ Designated as safety issue: No ]
- HbA1c [ Time Frame: value of Hba1C will be measured at screening visit and at the end of each study arm ] [ Designated as safety issue: No ]
- 4 and 7 points glucose profile [ Time Frame: patients will complete a diary before all clinical visits ] [ Designated as safety issue: No ]
- Insulin doses [ Time Frame: Insulin doses will be determined at baseline visit and every visit after ] [ Designated as safety issue: No ]
- Hypoglycemic events [ Time Frame: patients will report in their diary every episode of hypoglycemia ] [ Designated as safety issue: Yes ]
| Enrollment: | 44 |
| Study Start Date: | July 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: insulin Glargine + insulin Apidra
insulin Glargine + insulin Apidra
|
Drug: insulin Glargine + Insulin Apidra
12 wees treatment with Insulin Glargine + Insulin Apidra
|
|
Active Comparator: Insulin NPH + Insulin Apidra
12 weeks treatment with Insulin NPH + Insulin Apidra
|
Drug: Insulin NPH + Insulin Apidra: Active Comparator
Insulin NPH + Insulin Apidra: Active Comparator
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 7 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 1 diabetes diagnosed less than 12 months prior to study entry
- Age: 7-20 years old.
- HbA1c>/=8.0
- Signing inform consent form
Exclusion Criteria:
- 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.
- Patients participating in other device or drug studies.
- Any contraindication to insulin glargine and or insulin Apidra and or Insulin NPH according to SmPC.
- Inability, of adolescent or parent, to understand/complete the Treatment satisfaction questionnaire.
Contacts and Locations| Israel | |
| Soroka hospital | |
| Bear Sheva, Israel | |
| Rambam Hospital | |
| Haifa, Israel | |
| Health care unit- Jerusalem | |
| Jerusalem, Israel | |
| Schnider children medical center | |
| Petach-Tikva, Israel | |
| Principal Investigator: | Moshe Phillip, Professor | Rabin Medical Center |
More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00925977 History of Changes |
| Other Study ID Numbers: | rmc005275ctil |
| Study First Received: | June 22, 2009 |
| Last Updated: | June 4, 2012 |
| Health Authority: | Israel: "Clalit Health Services" |
Keywords provided by Rabin Medical Center:
|
treatment satisfaction insulin Glargine insulin Apidra NPH insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Glargine |
Insulin glulisine Insulin Insulin, NPH Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013