Trial Outcomes & Findings for The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children (NCT NCT00913497)

NCT ID: NCT00913497

Last Updated: 2023-09-18

Results Overview

Compare average blood glucose at 2 and 4 hours post prandial minus blood glucose at baseline (prior to eating)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: measured daily at baseline, 2 and 4 hours post prandial for 20 days
• Results posted on: 2023-09-18

Participant Flow

This study is indicated to technically be a crossover study, however, participants were asked to take one medication on even days and the other on odd days. There was no washout period.

Participant milestones

Measure	Insulin Glulisine and Insuline Asparte insulin glulisine: Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials. Insulin Asparte: (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage of insulin glulisine and aspart given subcutaneously at breakfast on alternate (10 days each for a total of 20 days)
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Insulin Glulisine and Insuline Asparte insulin glulisine: Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials. Insulin Asparte: (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage of insulin glulisine and aspart given subcutaneously at breakfast on alternate (10 days each for a total of 20 days)
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Participants n=13 Participants insulin glulisine: 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 aspart: 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.
Age, Continuous	8.8 years STANDARD_DEVIATION 0.58 • n=13 Participants
Sex: Female, Male Female	5 Participants n=13 Participants
Sex: Female, Male Male	8 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants
HbA1C	7.7 percentage of total hemoglobin STANDARD_DEVIATION 0.54 • n=13 Participants
BMI	17.82 kg/m2 STANDARD_DEVIATION 2.47 • n=13 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Insulin Glulisine n=13 Participants insulin glulisine: 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 Aspart n=13 Participants insulin aspart: 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.
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 Baseline blood sugar (prior to eating)	136.4 mg/dL Standard Deviation 15.7	133.4 mg/dL Standard Deviation 14.7
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 2 hour postprandial Blood Glucose excursion (2h measurement minus baseline)	113.5 mg/dL Standard Deviation 65.2	98.6 mg/dL Standard Deviation 66.9
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 4 hour postprandial blood glucose excursion (4h measurement minus baseline)	5.5 mg/dL Standard Deviation 36.5	4.4 mg/dL Standard Deviation 36.7

SECONDARY outcome

Timeframe: measured daily at 2 and 4 hours postprandial for 20 days

Population: analysis data is gathered from the published article, no further data is available

Outcome measures

Measure	Insulin Glulisine n=13 Participants insulin glulisine: 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 Aspart n=13 Participants insulin aspart: 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.
Occurrence of Hypoglycemia; 2 hour post prandial hypoglycemia	8 number of events	9 number of events
Occurrence of Hypoglycemia; 4 hour post prandial hypoglycemia	19 number of events	26 number of events

Adverse Events

Insulin Glulisine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Insulin Aspart

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Glulisine n=13 participants at risk insulin glulisine: 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 Aspart n=13 participants at risk insulin aspart: 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.
Endocrine disorders hypoglycemia 2 hour postprandial	30.8% 4/13 • Number of events 8 • data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention. Adverse events were not specifically reported in the published work for this study. Patients in this study were members of both arms on alternating days.	38.5% 5/13 • Number of events 9 • data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention. Adverse events were not specifically reported in the published work for this study. Patients in this study were members of both arms on alternating days.
Endocrine disorders hypoglycemia 4 hours postprandial	61.5% 8/13 • Number of events 19 • data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention. Adverse events were not specifically reported in the published work for this study. Patients in this study were members of both arms on alternating days.	69.2% 9/13 • Number of events 26 • data gathered over 20 days of treatment. Participants alternated between study interventions for 10 days on each intervention. Adverse events were not specifically reported in the published work for this study. Patients in this study were members of both arms on alternating days.

Additional Information

Esther Peariso

Corewell Health

Phone: 6164860358

Email: esther.peariso@corewellhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place