Type 1 Diabetes MellitusPhase 4NCT01678235
Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus
A Phase 4 study testing Insulin glulisine and Insulin aspart in people with Type 1 Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glulisine and Insulin aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2011to Sep 2012
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes mellitus
- CSII for at least 3 months
- Duration of diabetes > 1 years
- Informed consent
Who cannot join
- Concomitant dietary restrictions (e.g. celiac disease or food allergy)
- Diabetes related complications
- Baseline hyperglycemia >150 mg/dl
- Any disease judged by the investigator to affect the trial
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, 01-184
About this study
Official title: The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.
The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).
Read the detailed description
Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glulisine, Insulin aspart
- Keywords
- diabetes, insulin pump, glulisine, aspart, glycemic index
- 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®
Insulin aspartDrug
Also called NovoRapid®
| Study group | Role | What they receive |
|---|---|---|
| GLU_ASP | Experimental | Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin glulisine
Second day: insulin aspart Receives: Drug: Insulin glulisine; Drug: Insulin aspart |
| ASP_GLU | Experimental | Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.
First day: insulin aspart
Second day: insulin glulisine Receives: Drug: Insulin glulisine; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemia
Measured: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
Secondary outcomes (4)
Hypoglycemia episodes
Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
Measured: 3-h study period
Glucose Area Under the Curve (AUC)
based on continuous glucose monitoring system
Measured: 3-h study period
Mean amplitude of glycemic excursion (MAGE)
Measured: 3-h study period
Difference between the maximum and baseline glycemia
Measured: 3-h study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Dżygało, MD, Principal investigator, Department of Pediatrics, Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678235
- Sponsor's protocol ID
- Glulisine_Aspart
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.
PubMed 24412929
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01678235
- Acronym / sponsor ID
- Glulisine_Aspart
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes, insulin pump, glulisine, aspart, glycemic index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Sep 2012 (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 aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).
Detailed description
Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLU_ASP | Experimental | Drug: Insulin glulisine, Drug: Insulin aspartPre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin glulisine Second day: insulin aspart |
| ASP_GLU | Experimental | Drug: Insulin glulisine, Drug: Insulin aspartPre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin aspart Second day: insulin glulisine |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Type 1 diabetes mellitus
- CSII for at least 3 months
- Duration of diabetes > 1 years
- Informed consent
Key exclusion criteria (4 listed)
- Concomitant dietary restrictions (e.g. celiac disease or food allergy)
- Diabetes related complications
- Baseline hyperglycemia >150 mg/dl
- Any disease judged by the investigator to affect the trial
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® | Drug | ASP_GLU, GLU_ASP |
| Insulin aspartAlso: NovoRapid® | Drug | ASP_GLU, GLU_ASP |
Primary outcome
Postprandial glycemia
Time frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
4 secondary outcomes
Hypoglycemia episodes
Time frame: 3-h study period
Glucose Area Under the Curve (AUC)
Time frame: 3-h study period
Mean amplitude of glycemic excursion (MAGE)
Time frame: 3-h study period
Difference between the maximum and baseline glycemia
Time frame: 3-h study period
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 7 Oct 2014.
- Results publication: PubMed 24412929Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.
Related trials for Type 1 Diabetes Mellitus
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.
Katarzyna Dżygało, MD principal investigator
Department of Pediatrics, Medical University of Warsaw, Poland
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 Medical University of Warsaw at 1 site in Poland.
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: finished, as of the sponsor's last update on 7 Oct 2014. 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 Poland. 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?
Postprandial glycemia (time frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast). 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 NCT01678235, which also lists 1 linked publication.
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 7 Oct 2014.