Type 1 DiabetesPhase 4NCT00206401
Lantus in the Treatment of Type 1 Diabetes Children
A Phase 4 study testing Lantus and short acting analogs Vs NPH and short acting analogs in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Lantus and short acting analogs Vs NPH and short acting analogs
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Oct 2006
- Phase
- Phase 4
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older).
- Patients newly diagnosed with T1DM within the past 3 months.
- Have an HgbA1c of less than 9.0%, after the initial run-in period of 3 months.
- Have a BMI of less than the 90th percentile for age.
- Randomization of subjects willing to participate in the study.
Who cannot join
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc) that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis.
- Lack of supportive family.
- Evidence or history of chemical abuse.
- Age less than 6 years or greater than 25 years.
- HbA1c level of greater than 9.0%, after the initial run-in period of 3 months.
- Have a BMI greater than the 90th percentile for age.
- Patients who are not newly diagnosed with T1DM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period. Twice during the course of the study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records blood sugar readings every 5 minutes) will be used to record all the changes in the blood glucose levels occurring over a 72-hour period.
Read the detailed description
The landmark report of the diabetes control and complications trial (DCCT) trial has shown that intensive management delays and/or prevents complications in small vessels associated with Type 1 diabetes (T1DM). To achieve the goals of the DCCT, a number of new insulin analogs( man-made insulins ) are now being incorporated into the management of patients with T1DM.
These insulin analogs are gaining importance with their ability to overcome the major obstacle to intensive insulin therapy, namely low blood glucose. In particular, insulin Glargine, considered a basal insulin, is being extensively used for management as an alternative to continuous insulin therapy injected into the tissue just below the skin. The major drawback to using insulin Glargine is that it has to be given as a separate injection and cannot be mixed with other insulins. This results in the undesirable administration of multiple insulin injections to a child with diabetes making the therapeutic plan more complex and adhering to the treatment plan more difficult.
In a previous study, (now accepted for publication in a leading diabetes journal, Diabetes Care), we have demonstrated, using continuous glucose monitoring system, that there is no significant difference in glucose concentrations (ie. high and low blood glucose episodes) when insulin Glargine is administered either mixed with a short-acting insulin analog or when giving it as a separate injection.
- Conditions
- Type 1 Diabetes
- Being tested
- Lantus and short acting analogs Vs NPH and short acting analogs
- Keywords
- Adolescents, Lantus
- 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.
Lantus and short acting analogs Vs NPH and short acting analogsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Secondary outcomes (1)
Glucose excursions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sponsored Programs, Baylor College of Medicine
- Investigators
- Rubina Heptulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206401
- Sponsor's protocol ID
- 16559
- Status last verified
- Jul 2016
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jul 2016
- Results posted
- No
Publications
Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA. Effects of mixing glargine and short-acting insulin analogs on glucose control. Diabetes Care. 2004 Nov;27(11):2739-40. doi: 10.2337/diacare.27.11.2739. No abstract available.
PubMed 15505016Hassan K, Rodriguez LM, Johnson SE, Tadlock S, Heptulla RA. A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes. Pediatrics. 2008 Mar;121(3):e466-72. doi: 10.1542/peds.2007-1679. Epub 2008 Feb 25.
PubMed 18299307
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00206401
- Acronym / sponsor ID
- 16559
- Conditions
- Type 1 Diabetes
- Keywords
- Adolescents, Lantus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Oct 2006
- First posted
- 21 Sep 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.
In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period. Twice during the course of the study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records blood sugar readings every 5 minutes) will be used to record all the changes in the blood glucose levels occurring over a 72-hour period.
Detailed description
The landmark report of the diabetes control and complications trial (DCCT) trial has shown that intensive management delays and/or prevents complications in small vessels associated with Type 1 diabetes (T1DM). To achieve the goals of the DCCT, a number of new insulin analogs( man-made insulins ) are now being incorporated into the management of patients with T1DM.
These insulin analogs are gaining importance with their ability to overcome the major obstacle to intensive insulin therapy, namely low blood glucose. In particular, insulin Glargine, considered a basal insulin, is being extensively used for management as an alternative to continuous insulin therapy injected into the tissue just below the skin. The major drawback to using insulin Glargine is that it has to be given as a separate injection and cannot be mixed with other insulins. This results in the undesirable administration of multiple insulin injections to a child with diabetes making the therapeutic plan more complex and adhering to the treatment plan more difficult.
In a previous study, (now accepted for publication in a leading diabetes journal, Diabetes Care), we have demonstrated, using continuous glucose monitoring system, that there is no significant difference in glucose concentrations (ie. high and low blood glucose episodes) when insulin Glargine is administered either mixed with a short-acting insulin analog or when giving it as a separate injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older).
- Patients newly diagnosed with T1DM within the past 3 months.
- Have an HgbA1c of less than 9.0%, after the initial run-in period of 3 months.
- Have a BMI of less than the 90th percentile for age.
- Randomization of subjects willing to participate in the study.
Key exclusion criteria (7 listed)
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc) that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis.
- Lack of supportive family.
- Evidence or history of chemical abuse.
- Age less than 6 years or greater than 25 years.
- HbA1c level of greater than 9.0%, after the initial run-in period of 3 months.
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 |
|---|---|---|
| Lantus and short acting analogs Vs NPH and short acting analogs | Drug | – |
Primary outcome
HbA1C
1 secondary outcome
Glucose excursions
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 14 Jul 2016.
- Results publication: PubMed 15505016Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA. Effects of mixing glargine and short-acting insulin analogs on glucose control. Diabetes Care. 2004 Nov;27(11):2739-40. doi: 10.2337/diacare.27.11.2739. No abstract available.
- Derived from this study: PubMed 18299307Hassan K, Rodriguez LM, Johnson SE, Tadlock S, Heptulla RA. A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes. Pediatrics. 2008 Mar;121(3):e466-72. doi: 10.1542/peds.2007-1679. Epub 2008 Feb 25.
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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.
Rubina Heptulla, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lantus and short acting analogs Vs NPH and short acting analogs in people with Type 1 Diabetes, run by Baylor College of Medicine 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 5 inclusion and 7 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 14 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HbA1C. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00206401, which also lists 2 linked publications.
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 14 Jul 2016.