Trial Outcomes & Findings for A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes (NCT NCT01159938)
NCT ID: NCT01159938
Last Updated: 2014-04-03
Results Overview
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
30 mins (pre-breakfast)
Results posted on
2014-04-03
Participant Flow
Participants with type 2 diabetes mellitus (T2DM) were randomized to either a high to low blood glucose sequence or a low to high blood glucose sequence dependent upon whether they received insulin lispro or not in the first study period. Participants were stratified into treatment arms based on their urinary albumin excretion rate (UAER).
Participant milestones
| Measure |
Healthy Participants
Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose \<6.1 millimoles/liter (mmol/L) and 2-hour glucose \<7.8 mmol/L. Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM With Albuminuria, High to Low
T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria, Low to High
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER, High to Low
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER, Low to High
T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|
|
First Study Period
STARTED
|
26
|
11
|
11
|
12
|
12
|
|
First Study Period
Received at Least 1 Dose of Study Drug
|
0
|
11
|
11
|
12
|
12
|
|
First Study Period
Safety and Efficacy Analysis Population
|
25
|
11
|
11
|
12
|
12
|
|
First Study Period
COMPLETED
|
26
|
11
|
10
|
12
|
12
|
|
First Study Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
Second Study Period
STARTED
|
0
|
11
|
10
|
12
|
12
|
|
Second Study Period
COMPLETED
|
0
|
11
|
10
|
12
|
12
|
|
Second Study Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy Participants
Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose \<6.1 millimoles/liter (mmol/L) and 2-hour glucose \<7.8 mmol/L. Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM With Albuminuria, High to Low
T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria, Low to High
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER, High to Low
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER, Low to High
T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|
|
First Study Period
Protocol Violation (Microalbuminuria)
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=25 Participants
Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose \<6.1 millimoles/liter (mmol/L) and 2-hour glucose \<7.8 mmol/L. Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM With Albuminuria
n=22 Participants
T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER
n=24 Participants
T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
24 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
25 participants
n=5 Participants
|
22 participants
n=7 Participants
|
24 participants
n=5 Participants
|
71 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 mins (pre-breakfast)Population: Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=45 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=45 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
Aortic PWV (n=44, 44, 21, 22, 23, 22)
|
10.99 meters per second (m/s)
Interval 9.98 to 11.99
|
10.73 meters per second (m/s)
Interval 9.72 to 11.73
|
11.56 meters per second (m/s)
Interval 10.08 to 13.04
|
11.31 meters per second (m/s)
Interval 9.86 to 12.75
|
10.41 meters per second (m/s)
Interval 9.01 to 11.81
|
10.15 meters per second (m/s)
Interval 8.71 to 11.59
|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
Brachial PWV (n=45, 45, 21, 22, 24, 23)
|
7.49 meters per second (m/s)
Interval 7.02 to 7.96
|
7.84 meters per second (m/s)
Interval 7.37 to 8.3
|
7.79 meters per second (m/s)
Interval 7.1 to 8.48
|
7.99 meters per second (m/s)
Interval 7.32 to 8.67
|
7.19 meters per second (m/s)
Interval 6.54 to 7.84
|
7.68 meters per second (m/s)
Interval 7.02 to 8.34
|
PRIMARY outcome
Timeframe: 60 mins (post-breakfast)Population: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=45 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=45 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
Aortic PWV (n= 44, 45, 21, 22, 23, 23)
|
10.19 meters per second (m/sec)
Interval 9.38 to 11.0
|
10.38 meters per second (m/sec)
Interval 9.57 to 11.18
|
10.26 meters per second (m/sec)
Interval 9.06 to 11.45
|
10.22 meters per second (m/sec)
Interval 9.06 to 11.38
|
10.12 meters per second (m/sec)
Interval 8.98 to 11.25
|
10.53 meters per second (m/sec)
Interval 9.39 to 11.67
|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
Brachial PWV (n=45, 45, 21, 22, 24, 23)
|
7.71 meters per second (m/sec)
Interval 7.27 to 8.16
|
7.80 meters per second (m/sec)
Interval 7.36 to 8.25
|
8.03 meters per second (m/sec)
Interval 7.37 to 8.69
|
8.00 meters per second (m/sec)
Interval 7.36 to 8.65
|
7.39 meters per second (m/sec)
Interval 6.78 to 8.01
|
7.61 meters per second (m/sec)
Interval 6.98 to 8.23
|
PRIMARY outcome
Timeframe: 120 mins (post-breakfast)Population: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=45 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=45 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
Aortic PWV (n=45, 44, 21, 22, 24, 22)
|
10.96 meters per second (m/sec)
Interval 9.83 to 12.1
|
10.76 meters per second (m/sec)
Interval 9.62 to 11.91
|
11.18 meters per second (m/sec)
Interval 9.5 to 12.87
|
10.61 meters per second (m/sec)
Interval 8.96 to 12.26
|
10.74 meters per second (m/sec)
Interval 9.17 to 12.32
|
10.92 meters per second (m/sec)
Interval 9.28 to 12.56
|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
Brachial PWV (n=45, 45, 21, 22, 24, 23)
|
7.66 meters per second (m/sec)
Interval 7.19 to 8.14
|
7.86 meters per second (m/sec)
Interval 7.38 to 8.34
|
7.84 meters per second (m/sec)
Interval 7.13 to 8.54
|
8.03 meters per second (m/sec)
Interval 7.33 to 8.72
|
7.49 meters per second (m/sec)
Interval 6.83 to 8.16
|
7.70 meters per second (m/sec)
Interval 7.02 to 8.37
|
PRIMARY outcome
Timeframe: 180 mins (post-breakfast)Population: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=45 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=45 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
Aortic PWV (n= 45, 45, 21, 22, 24, 23)
|
10.99 meters per second (m/sec)
Interval 9.99 to 12.0
|
11.28 meters per second (m/sec)
Interval 10.28 to 12.29
|
11.04 meters per second (m/sec)
Interval 9.55 to 12.52
|
11.47 meters per second (m/sec)
Interval 10.01 to 12.94
|
10.95 meters per second (m/sec)
Interval 9.55 to 12.35
|
11.09 meters per second (m/sec)
Interval 9.67 to 12.51
|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
Brachial PWV (n= 45, 45, 21, 22, 24, 23)
|
7.75 meters per second (m/sec)
Interval 7.29 to 8.22
|
7.91 meters per second (m/sec)
Interval 7.45 to 8.38
|
7.75 meters per second (m/sec)
Interval 7.06 to 8.44
|
8.32 meters per second (m/sec)
Interval 7.65 to 9.0
|
7.76 meters per second (m/sec)
Interval 7.11 to 8.41
|
7.50 meters per second (m/sec)
Interval 6.84 to 8.16
|
PRIMARY outcome
Timeframe: 240 mins (post-breakfast)Population: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=45 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=45 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
Aortic PWV (n= 45, 45, 21, 22, 24, 23)
|
11.09 meters per second (m/sec)
Interval 10.09 to 12.09
|
11.57 meters per second (m/sec)
Interval 10.57 to 12.57
|
10.99 meters per second (m/sec)
Interval 9.5 to 12.47
|
11.16 meters per second (m/sec)
Interval 9.7 to 12.62
|
11.19 meters per second (m/sec)
Interval 9.79 to 12.58
|
11.98 meters per second (m/sec)
Interval 10.56 to 13.39
|
|
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
Brachial PWV (n= 45, 45, 21, 22, 24, 23)
|
7.76 meters per second (m/sec)
Interval 7.28 to 8.24
|
8.16 meters per second (m/sec)
Interval 7.68 to 8.64
|
7.99 meters per second (m/sec)
Interval 7.28 to 8.7
|
8.42 meters per second (m/sec)
Interval 7.72 to 9.11
|
7.53 meters per second (m/sec)
Interval 6.86 to 8.2
|
7.90 meters per second (m/sec)
Interval 7.22 to 8.58
|
SECONDARY outcome
Timeframe: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)Population: Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation.
The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline \[30-minute (min) pre-breakfast\] is reported.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=25 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=21 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=24 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Change in Pulse Wave Amplitude (PWA)
60-Min Post-Breakfast
|
-4.4 percentage of systolic peak
Standard Deviation 5.19
|
-4.1 percentage of systolic peak
Standard Deviation 5.75 • Interval 16.53 to 22.65
|
-0.6 percentage of systolic peak
Standard Deviation 4.88 • Interval 17.78 to 23.82
|
-2.3 percentage of systolic peak
Standard Deviation 3.91 • Interval 15.13 to 20.92
|
-2.5 percentage of systolic peak
Standard Deviation 7.00 • Interval 15.5 to 21.29
|
—
|
|
Change in Pulse Wave Amplitude (PWA)
120-Min Post-Breakfast
|
-2.9 percentage of systolic peak
Standard Deviation 4.33
|
-3.7 percentage of systolic peak
Standard Deviation 5.09 • Interval 16.75 to 22.6
|
-1.7 percentage of systolic peak
Standard Deviation 6.81 • Interval 16.94 to 22.71
|
-2.9 percentage of systolic peak
Standard Deviation 4.45 • Interval 14.52 to 20.05
|
-2.3 percentage of systolic peak
Standard Deviation 6.80 • Interval 15.72 to 21.25
|
—
|
|
Change in Pulse Wave Amplitude (PWA)
180-Min Post-Breakfast
|
-1.9 percentage of systolic peak
Standard Deviation 6.41
|
-2.3 percentage of systolic peak
Standard Deviation 5.81 • Interval 18.13 to 24.24
|
-0.5 percentage of systolic peak
Standard Deviation 5.85 • Interval 18.11 to 24.13
|
1.0 percentage of systolic peak
Standard Deviation 5.50 • Interval 18.17 to 23.94
|
-1.1 percentage of systolic peak
Standard Deviation 7.28 • Interval 16.74 to 22.52
|
—
|
|
Change in Pulse Wave Amplitude (PWA)
240-Min Post-Breakfast
|
2.1 percentage of systolic peak
Standard Deviation 15.21
|
-2.2 percentage of systolic peak
Standard Deviation 5.31 • Interval 18.66 to 24.25
|
0.6 percentage of systolic peak
Standard Deviation 4.73 • Interval 19.31 to 24.82
|
-0.7 percentage of systolic peak
Standard Deviation 4.95 • Interval 16.93 to 22.22
|
-0.6 percentage of systolic peak
Standard Deviation 6.34 • Interval 17.63 to 22.92
|
—
|
SECONDARY outcome
Timeframe: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)Population: Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation.
The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline \[30-minute (min) pre-breakfast\] is reported.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=21 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=23 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Change in Peripheral Artery Tonometry (PAT)
120-Min Post-Breakfast (n= 23, 20, 22, 23, 23)
|
0.03 percentage of pulse amplitude
Standard Deviation 0.582
|
0.09 percentage of pulse amplitude
Standard Deviation 0.490 • Interval 1.85 to 2.31
|
0.11 percentage of pulse amplitude
Standard Deviation 0.445 • Interval 1.8 to 2.25
|
0.36 percentage of pulse amplitude
Standard Deviation 0.543 • Interval 1.82 to 2.25
|
-0.05 percentage of pulse amplitude
Standard Deviation 0.597 • Interval 1.79 to 2.23
|
—
|
|
Change in Peripheral Artery Tonometry (PAT)
240-Min Post-Breakfast (n= 24, 21, 22, 23, 21)
|
0.15 percentage of pulse amplitude
Standard Deviation 0.634
|
0.23 percentage of pulse amplitude
Standard Deviation 0.532 • Interval 1.91 to 2.42
|
0.32 percentage of pulse amplitude
Standard Deviation 0.585 • Interval 1.99 to 2.49
|
0.36 percentage of pulse amplitude
Standard Deviation 0.444 • Interval 1.8 to 2.28
|
0.24 percentage of pulse amplitude
Standard Deviation 0.559 • Interval 2.04 to 2.55
|
—
|
SECONDARY outcome
Timeframe: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)Population: Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation.
QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline \[30-minute (min) pre-breakfast\] are reported.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=25 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=21 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=21 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=24 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Change in QT Interval on Electrocardiogram (ECG)
60-Min Post-Breakfast (n=25, 20, 21, 24, 24)
|
12.1 milliseconds (msec)
Standard Deviation 11.71
|
23.8 milliseconds (msec)
Standard Deviation 81.00
|
6.5 milliseconds (msec)
Standard Deviation 9.12
|
11.0 milliseconds (msec)
Standard Deviation 10.47
|
11.3 milliseconds (msec)
Standard Deviation 14.73
|
—
|
|
Change in QT Interval on Electrocardiogram (ECG)
120-Min Post-Breakfast (n=25, 21, 21, 24, 24)
|
-0.4 milliseconds (msec)
Standard Deviation 12.29
|
18.0 milliseconds (msec)
Standard Deviation 75.72
|
-0.8 milliseconds (msec)
Standard Deviation 5.74
|
1.4 milliseconds (msec)
Standard Deviation 9.84
|
2.8 milliseconds (msec)
Standard Deviation 10.89
|
—
|
|
Change in QT Interval on Electrocardiogram (ECG)
180-Min Post-Breakfast (n=25, 21, 21, 23 ,24)
|
8.3 milliseconds (msec)
Standard Deviation 10.06
|
19.1 milliseconds (msec)
Standard Deviation 77.11
|
5.8 milliseconds (msec)
Standard Deviation 7.45
|
2.5 milliseconds (msec)
Standard Deviation 9.80
|
4.5 milliseconds (msec)
Standard Deviation 10.24
|
—
|
|
Change in QT Interval on Electrocardiogram (ECG)
240-Min Post-Breakfast (n=25, 21, 21, 24, 24)
|
10.4 milliseconds (msec)
Standard Deviation 13.05
|
18.5 milliseconds (msec)
Standard Deviation 75.04
|
7.2 milliseconds (msec)
Standard Deviation 7.63
|
5.0 milliseconds (msec)
Standard Deviation 9.67
|
5.6 milliseconds (msec)
Standard Deviation 11.87
|
—
|
SECONDARY outcome
Timeframe: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)Population: Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation.
Changes in BG from the baseline \[30-minute (min) pre-breakfast\] are reported.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=25 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=21 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=24 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Change in Blood Glucose (BG)
50-Min Post-Breakfast (n=24, 21, 22, 24, 24)
|
0.07 millimoles per liter (mmol/L)
Standard Deviation 1.191
|
4.98 millimoles per liter (mmol/L)
Standard Deviation 1.546
|
3.39 millimoles per liter (mmol/L)
Standard Deviation 1.510
|
5.59 millimoles per liter (mmol/L)
Standard Deviation 2.338
|
3.23 millimoles per liter (mmol/L)
Standard Deviation 2.257
|
—
|
|
Change in Blood Glucose (BG)
110-Min Post-Breakfast (n= 25, 21, 22, 24, 24)
|
-0.15 millimoles per liter (mmol/L)
Standard Deviation 0.729
|
4.73 millimoles per liter (mmol/L)
Standard Deviation 1.716
|
2.52 millimoles per liter (mmol/L)
Standard Deviation 1.723
|
5.58 millimoles per liter (mmol/L)
Standard Deviation 2.918
|
2.59 millimoles per liter (mmol/L)
Standard Deviation 2.561
|
—
|
|
Change in Blood Glucose (BG)
170-Min Post-Breakfast (n= 25, 21, 22, 24, 24)
|
-0.36 millimoles per liter (mmol/L)
Standard Deviation 0.656
|
3.14 millimoles per liter (mmol/L)
Standard Deviation 2.013
|
0.29 millimoles per liter (mmol/L)
Standard Deviation 1.691
|
3.65 millimoles per liter (mmol/L)
Standard Deviation 3.071
|
1.26 millimoles per liter (mmol/L)
Standard Deviation 2.637
|
—
|
|
Change in Blood Glucose (BG)
230-Min Post-Breakfast (n= 25, 21, 22, 24, 24)
|
-0.54 millimoles per liter (mmol/L)
Standard Deviation 0.412
|
1.78 millimoles per liter (mmol/L)
Standard Deviation 2.182
|
-0.92 millimoles per liter (mmol/L)
Standard Deviation 1.788
|
1.79 millimoles per liter (mmol/L)
Standard Deviation 2.529
|
-0.13 millimoles per liter (mmol/L)
Standard Deviation 2.124
|
—
|
SECONDARY outcome
Timeframe: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)Population: Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation.
The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline \[30-minute (min) pre-breakfast\] are reported.
Outcome measures
| Measure |
T2DM Overall (High Postprandial Glucose)
n=24 Participants
T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER \[albuminuria (defined as urinary albumin)\] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as \<20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or \<30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
|
T2DM Overall (Low Postprandial Glucose)
n=21 Participants
T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Albuminuria (High Postprandial Glucose)
n=22 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Albuminuria (Low Postprandial Glucose)
n=24 Participants
T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
T2DM With Normal UAER (High Postprandial Glucose)
n=23 Participants
T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
|
T2DM With Normal UAER (Low Postprandial Glucose)
T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
|
|---|---|---|---|---|---|---|
|
Change in Postprandial Pulse Wave Velocity (PWV)
240-Min Post-Breakfast (Brachial;n=23,21,22,24,23)
|
-0.10 meters per second (m/sec)
Standard Deviation 1.475
|
0.17 meters per second (m/sec)
Standard Deviation 1.177
|
0.41 meters per second (m/sec)
Standard Deviation 1.402
|
0.35 meters per second (m/sec)
Standard Deviation 1.415
|
0.23 meters per second (m/sec)
Standard Deviation 1.682
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
60-Min Post-Breakfast (Aortic;n=22,21,22,23,22)
|
-0.26 meters per second (m/sec)
Standard Deviation 1.410
|
-0.74 meters per second (m/sec)
Standard Deviation 3.244
|
-0.91 meters per second (m/sec)
Standard Deviation 4.888
|
-0.52 meters per second (m/sec)
Standard Deviation 2.031
|
0.22 meters per second (m/sec)
Standard Deviation 3.431
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
120-Min Post-Breakfast (Aortic;n=22,21,22,23,22)
|
0.25 meters per second (m/sec)
Standard Deviation 1.400
|
0.04 meters per second (m/sec)
Standard Deviation 4.702
|
-0.58 meters per second (m/sec)
Standard Deviation 3.392
|
0.09 meters per second (m/sec)
Standard Deviation 2.771
|
0.75 meters per second (m/sec)
Standard Deviation 3.124
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
180-Min Post-Breakfast (Aortic;n=23,21,22,23,22)
|
-0.00 meters per second (m/sec)
Standard Deviation 1.429
|
-0.32 meters per second (m/sec)
Standard Deviation 3.326
|
0.22 meters per second (m/sec)
Standard Deviation 2.983
|
0.48 meters per second (m/sec)
Standard Deviation 2.514
|
0.94 meters per second (m/sec)
Standard Deviation 3.488
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
240-Min Post-Breakfast (Aortic;n=23,21,22,23,22)
|
0.99 meters per second (m/sec)
Standard Deviation 1.372
|
-0.09 meters per second (m/sec)
Standard Deviation 3.128
|
0.00 meters per second (m/sec)
Standard Deviation 3.972
|
0.61 meters per second (m/sec)
Standard Deviation 3.032
|
1.65 meters per second (m/sec)
Standard Deviation 3.730
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
60-Min Post-Breakfast (Brachial;n=23,21,22,24,23)
|
-0.13 meters per second (m/sec)
Standard Deviation 1.294
|
0.23 meters per second (m/sec)
Standard Deviation 1.399
|
0.03 meters per second (m/sec)
Standard Deviation 1.243
|
0.19 meters per second (m/sec)
Standard Deviation 1.495
|
-0.06 meters per second (m/sec)
Standard Deviation 1.629
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
120-Min Post-Breakfast (Brachial;n=22,21,22,24,23)
|
0.23 meters per second (m/sec)
Standard Deviation 1.176
|
0.09 meters per second (m/sec)
Standard Deviation 0.935
|
0.09 meters per second (m/sec)
Standard Deviation 1.352
|
0.25 meters per second (m/sec)
Standard Deviation 1.475
|
-0.04 meters per second (m/sec)
Standard Deviation 1.567
|
—
|
|
Change in Postprandial Pulse Wave Velocity (PWV)
180-Min Post-Breakfast (Brachial;n=24,21,22,24,23)
|
-0.37 meters per second (m/sec)
Standard Deviation 1.518
|
-0.06 meters per second (m/sec)
Standard Deviation 1.394
|
0.35 meters per second (m/sec)
Standard Deviation 1.723
|
0.55 meters per second (m/sec)
Standard Deviation 1.694
|
-0.23 meters per second (m/sec)
Standard Deviation 1.761
|
—
|
Adverse Events
Healthy Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T2DM With Albuminuria
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T2DM With Normal UAER
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60