Type 1 Diabetes MellitusPhase 4NCT00913497

The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

A Phase 4 study testing insulin glulisine and insulin aspart in people with Type 1 Diabetes Mellitus, run by Corewell Health West at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart. Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: insulin glulisine and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Jan 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

current patient in the Helen DeVos Children's Hospital Diabetes Clinic;
ages 4-11 years;
prepubertal (Tanner Stage I);
diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;
at least six months from date of diagnosis of type 1 diabetes mellitus;
TSH within reference range and negative transglutaminase IgA antibodies within nine months of study start;
HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment;
at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin

Who cannot join

pubertal (Tanner stage 2 or greater);
concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;
receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;
intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;
use of any medication to treat diabetes other than those listed under in inclusion criteria;
potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Helen DeVos Childrens Hospital
Grand Rapids, Michigan, 49503

Other trials in United States

About this study

Official title: Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy

To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

Read the detailed description

This is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. Each subject will receive insulin glulisine for ten days and insulin aspart for ten days.

Conditions: Type 1 Diabetes Mellitus
Being tested: insulin glulisine, insulin aspart
Keywords: Type 1 diabetes mellitus in children, insulin glulisine, insulin aspart, post prandial
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 glulisineDrug
Also called (Apidra®)
Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days
insulin aspartDrug
Also called (NovoLog®)
Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.

Study groups in NCT00913497
Study group	Role	What they receive
insulin glulisine	Active comparator	Not described Receives: Drug: insulin glulisine
insulin aspart	Active comparator	Not described Receives: Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days
Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)
Measured: measured daily at baseline, 2 and 4 hours post prandial for 20 days

Secondary outcomes (1)

Occurrence of Hypoglycemia;
Measured: measured daily at 2 and 4 hours postprandial for 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jan 2012

First posted4 Jun 2009 (estimated)
Study startJun 2009
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 Diabetes MellitusStudies 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00913497
Sponsor's protocol ID: 2009-089
Status last verified: Sep 2023
First submitted: 2 Jun 2009
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
ClinicalTrials.gov ID: NCT00913497
Acronym / sponsor ID: 2009-089
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus in children, insulin glulisine, insulin aspart, post prandial
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Corewell Health WestUniversity, hospital or other
Collaborators: Helen DeVos Children's Hospital
Study start: Jun 2009
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 4 Jun 2009 (estimated)
Results: Posted 18 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
insulin glulisine	Active comparator	Drug: insulin glulisine
insulin aspart	Active comparator	Drug: insulin aspart

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

current patient in the Helen DeVos Children's Hospital Diabetes Clinic;
ages 4-11 years;
prepubertal (Tanner Stage I);
diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis;
at least six months from date of diagnosis of type 1 diabetes mellitus;

Key exclusion criteria (6 listed)

pubertal (Tanner stage 2 or greater);
concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications;
receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder;
intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;
use of any medication to treat diabetes other than those listed under in inclusion criteria;

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: (Apidra®)Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days	Drug	insulin glulisine
insulin aspartAlso: (NovoLog®)Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.	Drug	insulin aspart

Primary outcome

Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days
Time frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days
Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)

1 secondary outcome

Occurrence of Hypoglycemia;
Time frame: measured daily at 2 and 4 hours postprandial for 20 days

Results and safety

Results posted to the registry on 18 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Glulisine and Insuline Asparte	16	13

Primary outcome: Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days

Time frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days. Mean (Standard Deviation). Unit: mg/dL

Measure	Insulin Glulisine n = 13	Insulin Aspart n = 13
Baseline blood sugar (prior to eating)	136.4 (15.7)	133.4 (14.7)
2 hour postprandial Blood Glucose excursion (2h measurement minus baseline)	113.5 (65.2)	98.6 (66.9)
4 hour postprandial blood glucose excursion (4h measurement minus baseline)	5.5 (36.5)	4.4 (36.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Glulisine	0 of 13 (0%)	8 of 13 (61.5%)	0 of 13
Insulin Aspart	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13

Limitations and caveats (from the sponsor): This study was completed over 10 years ago, raw data is no longer available, the results reported in this entry are based on the published document for the trial that was published in 2013. This is the only information that is available for reporting. Per the published works, the target enrollment was met and data analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ayse P Cemeroglu, MD principal investigator

Helen DeVos Childrens Hospital

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 insulin glulisine and insulin aspart in people with Type 1 Diabetes Mellitus, run by Corewell Health West 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 6 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 18 Sep 2023. 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?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in the Two Hour and Four Hour Post Prandial Blood Glucose Levels Following Administration of Insulin Glulisine Versus Insulin Aspart at the End of the Twenty Study Days (time frame: measured daily at baseline, 2 and 4 hours post prandial for 20 days). 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 NCT00913497.

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 18 Sep 2023.