Diabetes Mellitus, Insulin-DependentPhase 3NCT00115570
Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
A Phase 3 study testing Insulin glulisine, insulin lispro and insulin glargine in people with Diabetes Mellitus, Insulin-Dependent, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- Insulin glulisine, insulin lispro and insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Nov 2006
- Phase
- Phase 3
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Girls/boys, 4-17 years, inclusive;
- Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study;
- Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis); or glutamic acid decarboxylase (GAD) antibody indicative of type 1 diabetes measured at any time before study; or requiring continuous insulin therapy from time of diagnosis;
- Onset of diabetes at least 1 year prior to visit 1 (V1) of study;
- Uninterrupted insulin therapy for at least 1 year before V1 of study;
- At V1, on stable insulin regimen of either NPH or insulin glargine as basal insulin and willing to have multiple daily injections of insulin;
- Glycated hemoglobin at V1 between ≥ 6.0 and ≤11.0 %;
- Ability/willingness to do blood glucose monitoring using sponsor-provided glucometer and subject diary.
Who cannot join
- Active proliferative diabetic retinopathy, defined by application of focal or panretinal photocoagulation or vitrectomy, 6 months before V1, or any other unstable/rapidly progressing retinopathy requiring surgical treatment (including laser photocoagulation) during study;
- Diabetes other than type 1 diabetes mellitus;
- Pregnancy (positive pregnancy blood test at V1) or breastfeeding;
- Pancreatectomized subjects;
- Subjects who have had pancreas and/or islet cell transplants;
- Treatment with any anti-diabetic oral agent at any time from diabetes diagnosis;
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- Treatment with systemic corticosteroids in last month before V1;
- Subjects on pump therapy during last 2 months before V1;
- Subjects requiring excessively high doses of insulin ("resistant" patients), for example, but not limited to, subjects receiving over 150 IU per day;
- Likelihood of needing treatment during study period with drugs not permitted by protocol
- Treatment with any investigational drug in last month before V1;
- History of primary seizure disorders;
- History of severe hypoglycemic episode accompanied by seizure and/or coma or diabetic ketoacidosis leading to hospitalization, or to care in emergency ward, 3 months prior to V1;
- History of hypoglycemia unawareness;
- History of hypersensitivity to insulin or insulin analogs or any of the excipients in insulin glulisine formulation or any of the excipients in other study insulin preparations formulations;
- Clinically relevant hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of protocol or interpretation of study results difficult and would, in the opinion of the investigator, preclude safe participation of subject in protocol;
- History of cardiac abnormalities and/or cardiovascular disorders;
- History of drug/alcohol abuse;
- Impaired hepatic function shown by, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than twice the normal upper limit for age at V1;
- Impaired renal function shown by, but not limited to, serum creatinine greater than 1.5 times upper limit for age at V1;
- Non fasting triglyceride level of >500 mg/dL (5.7 mmol/L) at V1;
- Parent/legally authorized representative unable to understand nature, scope, possible consequences of study;
- Parent/legally authorized representative unable to read/write;
- Subjects unlikely to comply with protocol, e.g. inability/unwillingness to participate in adequate training, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing study;
- Children/relatives of employee of sponsor or of sponsor representatives;
- Children or relatives of investigator, any sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conduct of protocol;
- Subjects who have previously been treated with insulin glulisine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Efficacy and Safety of Insulin Glulisine Compared With Insulin Lispro in Children and Adolescents With Type 1 Diabetes Mellitus: A 26 Week, Multicenter, Open, Parallel Clinical Trial
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- Insulin glulisine, insulin lispro, insulin glargine, NPH insulin
- Keywords
- Diabetes,Insulin-Dependent, pediatric,rapid acting injection
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glulisineDrug
Also called apidra
Subcutaneous injection
insulin lisproDrug
Subcutaneous injection
insulin glargineDrug
Subcutaneous injection once daily
NPH insulinDrug
subcutaneous injection twice daily
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glulisine | Experimental | Insulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks Receives: Drug: Insulin glulisine; Drug: insulin glargine; Drug: NPH insulin |
| Insulin Lispro | Active comparator | Insulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks Receives: Drug: insulin lispro; Drug: insulin glargine; Drug: NPH insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint
Measured: week 26 or last observed treatment
Secondary outcomes (4)
Change from Baseline in GHb at weeks 12 and 26
Measured: weeks 12 and 26
Change from Baseline in Self-monitored glucose parameters
Measured: weeks 4, 12, 18, 26, and endpoint;
Incidence of Symptomatic hypoglycemia
Measured: first dose of study up to last dose
Change from Baseline in basal insulin dose
Measured: week 4, 12, 18, 26, and endpoint;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Arethi PHILOTHEOU, Principal investigator, UCT Diabetes Clinical Trials Unit - Faculty of Health Sciences - South-Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115570
- Sponsor's protocol ID
- EFC6096
- Other IDs
- HMR 1964
- Status last verified
- May 2016
- First submitted
- 23 Jun 2005
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Insulin Glulisine Compared With Insulin Lispro in Children and Adolescents With Type 1 Diabetes Mellitus: A 26 Week, Multicenter, Open, Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT00115570
- Acronym / sponsor ID
- EFC6096
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- Diabetes,Insulin-Dependent, pediatric,rapid acting injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 24 Jun 2005 (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.
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Glulisine | Experimental | Drug: Insulin glulisine, Drug: insulin glargine, Drug: NPH insulinInsulin Glulisine (100UI/ml), at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine for a maximum of 26 weeks |
| Insulin Lispro | Active comparator | Drug: insulin lispro, Drug: insulin glargine, Drug: NPH insulinInsulin Lispro (100UI/ml) Subcutaneous (SC) injection , at least twice daily, in association with basal insulin therapy (NPH insulin or insulin glargine ) for a maximum of 30 weeks |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Girls/boys, 4-17 years, inclusive;
- Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study;
- Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis); or glutamic acid decarboxylase (GAD) antibody indicative of type 1 diabetes measured at any time before study; or requiring continuous insulin therapy from time of diagnosis;
- Onset of diabetes at least 1 year prior to visit 1 (V1) of study;
- Uninterrupted insulin therapy for at least 1 year before V1 of study;
Key exclusion criteria (27 listed)
- Active proliferative diabetic retinopathy, defined by application of focal or panretinal photocoagulation or vitrectomy, 6 months before V1, or any other unstable/rapidly progressing retinopathy requiring surgical treatment (including laser photocoagulation) during study;
- Diabetes other than type 1 diabetes mellitus;
- Pregnancy (positive pregnancy blood test at V1) or breastfeeding;
- Pancreatectomized subjects;
- Subjects who have had pancreas and/or islet cell transplants;
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 glulisineAlso: apidraSubcutaneous injection | Drug | Insulin Glulisine |
| insulin lisproSubcutaneous injection | Drug | Insulin Lispro |
| insulin glargineSubcutaneous injection once daily | Drug | Insulin Glulisine, Insulin Lispro |
| NPH insulinsubcutaneous injection twice daily | Drug | Insulin Glulisine, Insulin Lispro |
Primary outcome
Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint
Time frame: week 26 or last observed treatment
4 secondary outcomes
Change from Baseline in GHb at weeks 12 and 26
Time frame: weeks 12 and 26
Change from Baseline in Self-monitored glucose parameters
Time frame: weeks 4, 12, 18, 26, and endpoint;
Incidence of Symptomatic hypoglycemia
Time frame: first dose of study up to last dose
Change from Baseline in basal insulin dose
Time frame: week 4, 12, 18, 26, and endpoint;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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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.
Dr Arethi PHILOTHEOU principal investigator
UCT Diabetes Clinical Trials Unit - Faculty of Health Sciences - South-Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glulisine, insulin lispro and insulin glargine in people with Diabetes Mellitus, Insulin-Dependent, run by Sanofi at 1 site in United States.
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 8 inclusion and 27 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: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint (time frame: week 26 or last observed treatment). 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 20 May 2016.