Diabetes Type 1NCT00925977
Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents
A study testing insulin Glargine + Insulin Apidra and Insulin NPH + Insulin Apidra: Active Comparator in people with Diabetes Type 1, run by Rabin Medical Center at 4 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- insulin Glargine + Insulin Apidra and Insulin NPH + Insulin Apidra: Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesIsrael
- Study dates
- Jul 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes diagnosed less than 12 months prior to study entry
- Age: 7-20 years old.
- HbA1c>/=8.0
- Signing inform consent form
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Soroka hospital
Bear Sheva
Rambam Hospital
Haifa
Health care unit- Jerusalem
Jerusalem
Schnider children medical center
Petah Tikva
About this study
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.
Read the 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.
- Conditions
- Diabetes Type 1
- Being tested
- insulin Glargine + Insulin Apidra, Insulin NPH + Insulin Apidra: Active Comparator
- Keywords
- treatment satisfaction, insulin Glargine, insulin Apidra, NPH insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin Glargine + Insulin ApidraDrug
12 wees treatment with Insulin Glargine + Insulin Apidra
Insulin NPH + Insulin Apidra: Active ComparatorDrug
Insulin NPH + Insulin Apidra: Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| insulin Glargine + insulin Apidra | Active comparator | insulin Glargine + insulin Apidra Receives: Drug: insulin Glargine + Insulin Apidra |
| Insulin NPH + Insulin Apidra | Active comparator | 12 weeks treatment with Insulin NPH + Insulin Apidra Receives: Drug: Insulin NPH + Insulin Apidra: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment satisfaction
Measured: patients will complete DTSQ at months 0,12 and 24
Secondary outcomes (4)
HbA1c
Measured: value of Hba1C will be measured at screening visit and at the end of each study arm
4 and 7 points glucose profile
Measured: patients will complete a diary before all clinical visits
Insulin doses
Measured: Insulin doses will be determined at baseline visit and every visit after
Hypoglycemic events
Measured: patients will report in their diary every episode of hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Professor, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925977
- Sponsor's protocol ID
- rmc005275ctil
- Status last verified
- Jun 2012
- First submitted
- 22 Jun 2009
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00925977
- Acronym / sponsor ID
- rmc005275ctil
- Conditions
- Diabetes Type 1
- Keywords
- treatment satisfaction, insulin Glargine, insulin Apidra, NPH insulin
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin Glargine + insulin Apidra | Active comparator | Drug: insulin Glargine + Insulin Apidrainsulin Glargine + insulin Apidra |
| Insulin NPH + Insulin Apidra | Active comparator | Drug: Insulin NPH + Insulin Apidra: Active Comparator12 weeks treatment with Insulin NPH + Insulin Apidra |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Type 1 diabetes diagnosed less than 12 months prior to study entry
- Age: 7-20 years old.
- HbA1c>/=8.0
- Signing inform consent form
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin Glargine + Insulin Apidra12 wees treatment with Insulin Glargine + Insulin Apidra | Drug | insulin Glargine + insulin Apidra |
| Insulin NPH + Insulin Apidra: Active ComparatorInsulin NPH + Insulin Apidra: Active Comparator | Drug | Insulin NPH + Insulin Apidra |
Primary outcome
Treatment satisfaction
Time frame: patients will complete DTSQ at months 0,12 and 24
4 secondary outcomes
HbA1c
Time frame: value of Hba1C will be measured at screening visit and at the end of each study arm
4 and 7 points glucose profile
Time frame: patients will complete a diary before all clinical visits
Insulin doses
Time frame: Insulin doses will be determined at baseline visit and every visit after
Hypoglycemic events
Time frame: patients will report in their diary every episode of hypoglycemia
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
Related trials for Diabetes Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Professor principal investigator
Rabin Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin Glargine + Insulin Apidra and Insulin NPH + Insulin Apidra: Active Comparator in people with Diabetes Type 1, run by Rabin Medical Center at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment satisfaction (time frame: patients will complete DTSQ at months 0,12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.