Trial Outcomes & Findings for Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids (NCT NCT01293396)
NCT ID: NCT01293396
Last Updated: 2021-06-30
Results Overview
Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Results posted on
2021-06-30
Participant Flow
50 patients were screened and in total 20 randomizations were performed. After randomization 20 randomized subjects finished all three study visits.
All subjects received all of the three insulins within various sequences in a randomized order. Randomisation lists for the insulin sequence were provided by a researcher otherwise not involved in the clinical trial performance.
Participant milestones
| Measure |
Group 1
Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period.
|
Group 2
Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period
|
Group 3
Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period.
|
|---|---|---|---|
|
First Intervention
STARTED
|
6
|
7
|
7
|
|
First Intervention
COMPLETED
|
6
|
7
|
7
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Wash Out Period 1 (3 Days)
STARTED
|
6
|
7
|
7
|
|
Wash Out Period 1 (3 Days)
COMPLETED
|
6
|
7
|
7
|
|
Wash Out Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
5
|
10
|
|
Second Intervention
COMPLETED
|
5
|
5
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Wash Out Period 2 (3 Days)
STARTED
|
5
|
5
|
10
|
|
Wash Out Period 2 (3 Days)
COMPLETED
|
5
|
5
|
10
|
|
Wash Out Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
9
|
8
|
3
|
|
Third Intervention
COMPLETED
|
9
|
8
|
3
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
Baseline characteristics by cohort
| Measure |
Overall Study
n=20 Participants
20 patients with type 2 diabetes receive insulin aspart, premixed biphasic insulin 30 and premixed biphasic insulin aspart 70 in randomized order.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Area Over Basal for Postprandial Glucose From 0 to 600min
|
591 mg*/min/dL
Standard Deviation 681
|
220 mg*/min/dL
Standard Deviation 617
|
197 mg*/min/dL
Standard Deviation 550
|
PRIMARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Area Over Basal for Postprandial Triglycerides
|
484 mg*min/dL
Standard Deviation 342
|
358 mg*min/dL
Standard Deviation 544
|
412 mg*min/dL
Standard Deviation 831
|
SECONDARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Maximum glucose increase from baseline to 600min after baseline
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Maximum Glucose Increase
|
89.25 mg/dL
Standard Deviation 57.85
|
55.95 mg/dL
Standard Deviation 42.44
|
60.25 mg/dL
Standard Deviation 40.45
|
SECONDARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Maximum trigylceride increase from Baseline to 600min after Baseline
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Maximum Triglyceride Increase
|
484 mg/dL
Standard Deviation 342
|
358 mg/dL
Standard Deviation 544
|
412 mg/dL
Standard Deviation 831
|
SECONDARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Area Over Basal for Postprandial Insulin
|
211.2 µU*min/L
Standard Deviation 149.7
|
141.2 µU*min/L
Standard Deviation 155.3
|
128.6 µU*min/L
Standard Deviation 106.7
|
SECONDARY outcome
Timeframe: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Outcome measures
| Measure |
Biphasic Insulin Aspart 30
n=20 Participants
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 Participants
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 Participants
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Area Over Basal for Postprandial C-peptide
|
21.6 mg*min/mL
Standard Deviation 14.1
|
12.8 mg*min/mL
Standard Deviation 11.5
|
13.4 mg*min/mL
Standard Deviation 11.8
|
Adverse Events
Biphasic Insulin Aspart 30
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Biphasic Insulin Aspart 70
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Insulin Aspart
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biphasic Insulin Aspart 30
n=20 participants at risk
Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch.
|
Biphasic Insulin Aspart 70
n=20 participants at risk
Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch.
|
Insulin Aspart
n=20 participants at risk
Insulin Aspart: Patients received insulin aspart before breakfast and before lunch.
|
|---|---|---|---|
|
Endocrine disorders
Mild Hypoglycaemic Event
|
5.0%
1/20 • Number of events 2
|
10.0%
2/20 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
|
Endocrine disorders
Moderate Hypoglycaemic Event
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place