Diabetes Mellitus, Type 2
Conditions
Brief summary
This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.
Interventions
DRUGLispro
Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Are diagnosed with T2DM (according to the American Diabetes Association classification \[American Diabetes Association 2006\]) and on insulin therapy for at least 6 months. * Have not smoked in the last 12 hours prior to the study visit. * Have albuminuria but normal kidney function or normal UAER \[UAER \< 20 micrograms per minute (mcg/min) or \< 30 milligrams/24 hours (mg/24h), respectively\]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI). * Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol. * Each participant must understand the nature of the study and must sign an informed consent document (ICD). Healthy participants are eligible to be included in the study only if they meet all of the following criteria: * Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study. * Normal glucose tolerance and normal UAER (UAER between \< 20 μg/min in the overnight urine collection or \< 30 mg/24h in the 24-h urine collection). * Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol. * Each healthy participant must understand the nature of the study and must sign an ICD.
Exclusion criteria
Participants/healthy participants will be excluded from the study if they meet any of the following criteria: * Have had a cardiovascular event \[stroke, myocardial infarction (MI), coronary artery procedure (by-pass surgery or angioplasty), limb amputation due to ischemia, peripheral vascular disease\] or coronary heart disease confirmed by exercise test or scintigraphy. * Have arrhythmias. * Have an acute infection. * Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast | 240 mins (post-breakfast) | 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. |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast | 30 mins (pre-breakfast) | 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. |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast | 60 mins (post-breakfast) | 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. |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast | 120 mins (post-breakfast) | 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. |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast | 180 mins (post-breakfast) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulse Wave Amplitude (PWA) | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) | 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. |
| Change in Peripheral Artery Tonometry (PAT) | 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast) | 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. |
| Change in QT Interval on Electrocardiogram (ECG) | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) | 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. |
| Change in Blood Glucose (BG) | 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast) | Changes in BG from the baseline \[30-minute (min) pre-breakfast\] are reported. |
| Change in Postprandial Pulse Wave Velocity (PWV) | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) | 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. |
Countries
Finland
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Healthy 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. | 25 |
| T2DM With Albuminuria 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. | 22 |
| T2DM With Normal UAER 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. | 24 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| First Study Period | Protocol Violation (Microalbuminuria) | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Healthy Participants | T2DM With Albuminuria | T2DM With Normal UAER | Total |
|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 6.6 | 61.2 years STANDARD_DEVIATION 4.9 | 63.7 years STANDARD_DEVIATION 5.2 | 61.2 years STANDARD_DEVIATION 5.9 |
| Race/Ethnicity, Customized White | 25 participants | 22 participants | 24 participants | 71 participants |
| Region of Enrollment Finland | 25 participants | 22 participants | 24 participants | 71 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 24 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 10.76 meters per second (m/sec) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 7.86 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 11.18 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 7.84 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 10.61 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 8.03 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 10.74 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 7.49 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 10.92 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 7.70 meters per second (m/sec) |
p-value: 0.72495% CI: [-0.94, 1.34]ANCOVA
p-value: 0.47995% CI: [-1.05, 2.2]ANCOVA
p-value: 0.82595% CI: [-1.76, 1.41]ANCOVA
p-value: 0.37895% CI: [-0.65, 0.25]ANCOVA
p-value: 0.55395% CI: [-0.84, 0.46]ANCOVA
p-value: 0.51295% CI: [-0.83, 0.42]ANCOVA
Primary
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 11.28 meters per second (m/sec) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 7.91 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 11.04 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 11.47 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 8.32 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 10.95 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 7.76 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 11.09 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 7.50 meters per second (m/sec) |
p-value: 0.46695% CI: [-1.09, 0.51]ANCOVA
p-value: 0.44995% CI: [-1.6, 0.72]ANCOVA
p-value: 0.79295% CI: [-1.25, 0.96]ANCOVA
p-value: 0.49395% CI: [-0.63, 0.31]ANCOVA
p-value: 0.09195% CI: [-1.25, 0.1]ANCOVA
p-value: 0.42595% CI: [-0.39, 0.9]ANCOVA
Primary
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 11.57 meters per second (m/sec) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 8.16 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 10.99 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 7.99 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 11.16 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 8.42 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 11.19 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 7.53 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 11.98 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 7.90 meters per second (m/sec) |
p-value: 0.27595% CI: [-1.36, 0.4]ANCOVA
p-value: 0.78495% CI: [-1.44, 1.1]ANCOVA
p-value: 0.19795% CI: [-2.01, 0.43]ANCOVA
p-value: 0.12295% CI: [-0.9, 0.11]ANCOVA
p-value: 0.24695% CI: [-1.16, 0.31]ANCOVA
p-value: 0.29895% CI: [-1.06, 0.33]ANCOVA
Primary
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 10.73 meters per second (m/s) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 7.84 meters per second (m/s) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 11.56 meters per second (m/s) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 7.79 meters per second (m/s) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 11.31 meters per second (m/s) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 7.99 meters per second (m/s) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 10.41 meters per second (m/s) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 7.19 meters per second (m/s) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 10.15 meters per second (m/s) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 7.68 meters per second (m/s) |
p-value: 0.61795% CI: [-0.78, 1.3]ANCOVA
p-value: 0.73295% CI: [-1.23, 1.73]ANCOVA
p-value: 0.71595% CI: [-1.2, 1.73]ANCOVA
p-value: 0.17795% CI: [-0.85, 0.16]ANCOVA
p-value: 0.57995% CI: [-0.94, 0.53]ANCOVA
p-value: 0.16795% CI: [-1.19, 0.21]ANCOVA
Primary
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
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.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (High Postprandial Glucose) | 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) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 10.38 meters per second (m/sec) |
| T2DM Overall (Low Postprandial Glucose) | 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) | 7.80 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 10.26 meters per second (m/sec) |
| T2DM With Albuminuria (High Postprandial Glucose) | 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) | 8.03 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 8.00 meters per second (m/sec) |
| T2DM With Albuminuria (Low Postprandial Glucose) | 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) | 10.22 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 10.12 meters per second (m/sec) |
| T2DM With Normal UAER (High Postprandial Glucose) | 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) | 7.39 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 10.53 meters per second (m/sec) |
| T2DM With Normal UAER (Low Postprandial Glucose) | 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) | 7.61 meters per second (m/sec) |
p-value: 0.67695% CI: [-1.1, 0.72]ANCOVA
p-value: 0.95795% CI: [-1.27, 1.34]ANCOVA
p-value: 0.51395% CI: [-1.68, 0.85]ANCOVA
p-value: 0.62395% CI: [-0.47, 0.28]ANCOVA
p-value: 0.91695% CI: [-0.51, 0.57]ANCOVA
p-value: 0.41395% CI: [-0.73, 0.31]ANCOVA
Secondary
Change in Blood Glucose (BG)
Changes in BG from the baseline \[30-minute (min) pre-breakfast\] are reported.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 230-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 1.78 millimoles per liter (mmol/L) | Standard Deviation 2.182 |
| T2DM Overall (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 170-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 3.14 millimoles per liter (mmol/L) | Standard Deviation 2.013 |
| T2DM Overall (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 50-Min Post-Breakfast (n=24, 21, 22, 24, 24) | 4.98 millimoles per liter (mmol/L) | Standard Deviation 1.546 |
| T2DM Overall (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 110-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 4.73 millimoles per liter (mmol/L) | Standard Deviation 1.716 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Blood Glucose (BG) | 170-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 0.29 millimoles per liter (mmol/L) | Standard Deviation 1.691 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Blood Glucose (BG) | 110-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 2.52 millimoles per liter (mmol/L) | Standard Deviation 1.723 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Blood Glucose (BG) | 230-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | -0.92 millimoles per liter (mmol/L) | Standard Deviation 1.788 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Blood Glucose (BG) | 50-Min Post-Breakfast (n=24, 21, 22, 24, 24) | 3.39 millimoles per liter (mmol/L) | Standard Deviation 1.51 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 170-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 3.65 millimoles per liter (mmol/L) | Standard Deviation 3.071 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 110-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 5.58 millimoles per liter (mmol/L) | Standard Deviation 2.918 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 50-Min Post-Breakfast (n=24, 21, 22, 24, 24) | 5.59 millimoles per liter (mmol/L) | Standard Deviation 2.338 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Blood Glucose (BG) | 230-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 1.79 millimoles per liter (mmol/L) | Standard Deviation 2.529 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Blood Glucose (BG) | 230-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | -0.13 millimoles per liter (mmol/L) | Standard Deviation 2.124 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Blood Glucose (BG) | 170-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 1.26 millimoles per liter (mmol/L) | Standard Deviation 2.637 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Blood Glucose (BG) | 110-Min Post-Breakfast (n= 25, 21, 22, 24, 24) | 2.59 millimoles per liter (mmol/L) | Standard Deviation 2.561 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Blood Glucose (BG) | 50-Min Post-Breakfast (n=24, 21, 22, 24, 24) | 3.23 millimoles per liter (mmol/L) | Standard Deviation 2.257 |
Secondary
Change in Peripheral Artery Tonometry (PAT)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (Low Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 120-Min Post-Breakfast (n= 23, 20, 22, 23, 23) | 0.09 percentage of pulse amplitude | Standard Deviation 0.49 |
| T2DM Overall (Low Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 240-Min Post-Breakfast (n= 24, 21, 22, 23, 21) | 0.23 percentage of pulse amplitude | Standard Deviation 0.532 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 120-Min Post-Breakfast (n= 23, 20, 22, 23, 23) | 0.11 percentage of pulse amplitude | Standard Deviation 0.445 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 240-Min Post-Breakfast (n= 24, 21, 22, 23, 21) | 0.32 percentage of pulse amplitude | Standard Deviation 0.585 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 240-Min Post-Breakfast (n= 24, 21, 22, 23, 21) | 0.36 percentage of pulse amplitude | Standard Deviation 0.444 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 120-Min Post-Breakfast (n= 23, 20, 22, 23, 23) | 0.36 percentage of pulse amplitude | Standard Deviation 0.543 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 120-Min Post-Breakfast (n= 23, 20, 22, 23, 23) | -0.05 percentage of pulse amplitude | Standard Deviation 0.597 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Peripheral Artery Tonometry (PAT) | 240-Min Post-Breakfast (n= 24, 21, 22, 23, 21) | 0.24 percentage of pulse amplitude | Standard Deviation 0.559 |
p-value: 0.90595% CI: [-0.31, 0.27]ANCOVA
p-value: 0.00495% CI: [0.14, 0.69]ANCOVA
p-value: 0.58495% CI: [-0.41, 0.23]ANCOVA
p-value: 0.43695% CI: [-0.19, 0.44]ANCOVA
Secondary
Change in Postprandial Pulse Wave Velocity (PWV)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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 1.4 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 1.41 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | -0.32 meters per second (m/sec) | Standard Deviation 3.326 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | -0.74 meters per second (m/sec) | Standard Deviation 3.244 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | 0.04 meters per second (m/sec) | Standard Deviation 4.702 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.23 meters per second (m/sec) | Standard Deviation 1.399 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Brachial;n=24,21,22,24,23) | -0.06 meters per second (m/sec) | Standard Deviation 1.394 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | -0.09 meters per second (m/sec) | Standard Deviation 3.128 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.17 meters per second (m/sec) | Standard Deviation 1.177 |
| T2DM Overall (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Brachial;n=22,21,22,24,23) | 0.09 meters per second (m/sec) | Standard Deviation 0.935 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Brachial;n=22,21,22,24,23) | 0.09 meters per second (m/sec) | Standard Deviation 1.352 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 0.22 meters per second (m/sec) | Standard Deviation 2.983 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.03 meters per second (m/sec) | Standard Deviation 1.243 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 0.00 meters per second (m/sec) | Standard Deviation 3.972 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.41 meters per second (m/sec) | Standard Deviation 1.402 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | -0.58 meters per second (m/sec) | Standard Deviation 3.392 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Brachial;n=24,21,22,24,23) | 0.35 meters per second (m/sec) | Standard Deviation 1.723 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | -0.91 meters per second (m/sec) | Standard Deviation 4.888 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.19 meters per second (m/sec) | Standard Deviation 1.495 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Brachial;n=24,21,22,24,23) | 0.55 meters per second (m/sec) | Standard Deviation 1.694 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 0.48 meters per second (m/sec) | Standard Deviation 2.514 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | -0.52 meters per second (m/sec) | Standard Deviation 2.031 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.35 meters per second (m/sec) | Standard Deviation 1.415 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Brachial;n=22,21,22,24,23) | 0.25 meters per second (m/sec) | Standard Deviation 1.475 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | 0.09 meters per second (m/sec) | Standard Deviation 2.771 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 0.61 meters per second (m/sec) | Standard Deviation 3.032 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | 0.23 meters per second (m/sec) | Standard Deviation 1.682 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | 0.22 meters per second (m/sec) | Standard Deviation 3.431 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Aortic;n=22,21,22,23,22) | 0.75 meters per second (m/sec) | Standard Deviation 3.124 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 0.94 meters per second (m/sec) | Standard Deviation 3.488 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 60-Min Post-Breakfast (Brachial;n=23,21,22,24,23) | -0.06 meters per second (m/sec) | Standard Deviation 1.629 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 120-Min Post-Breakfast (Brachial;n=22,21,22,24,23) | -0.04 meters per second (m/sec) | Standard Deviation 1.567 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 180-Min Post-Breakfast (Brachial;n=24,21,22,24,23) | -0.23 meters per second (m/sec) | Standard Deviation 1.761 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Postprandial Pulse Wave Velocity (PWV) | 240-Min Post-Breakfast (Aortic;n=23,21,22,23,22) | 1.65 meters per second (m/sec) | Standard Deviation 3.73 |
Secondary
Change in Pulse Wave Amplitude (PWA)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 180-Min Post-Breakfast | -1.9 percentage of systolic peak | Standard Deviation 6.41 |
| T2DM Overall (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 60-Min Post-Breakfast | -4.4 percentage of systolic peak | Standard Deviation 5.19 |
| T2DM Overall (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 120-Min Post-Breakfast | -2.9 percentage of systolic peak | Standard Deviation 4.33 |
| T2DM Overall (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 240-Min Post-Breakfast | 2.1 percentage of systolic peak | Standard Deviation 15.21 |
| T2DM Overall (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 120-Min Post-Breakfast | -3.7 percentage of systolic peak | Standard Deviation 5.09 |
| T2DM Overall (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 60-Min Post-Breakfast | -4.1 percentage of systolic peak | Standard Deviation 5.75 |
| T2DM Overall (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 180-Min Post-Breakfast | -2.3 percentage of systolic peak | Standard Deviation 5.81 |
| T2DM Overall (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 240-Min Post-Breakfast | -2.2 percentage of systolic peak | Standard Deviation 5.31 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 60-Min Post-Breakfast | -0.6 percentage of systolic peak | Standard Deviation 4.88 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 240-Min Post-Breakfast | 0.6 percentage of systolic peak | Standard Deviation 4.73 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 120-Min Post-Breakfast | -1.7 percentage of systolic peak | Standard Deviation 6.81 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 180-Min Post-Breakfast | -0.5 percentage of systolic peak | Standard Deviation 5.85 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 60-Min Post-Breakfast | -2.3 percentage of systolic peak | Standard Deviation 3.91 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 240-Min Post-Breakfast | -0.7 percentage of systolic peak | Standard Deviation 4.95 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 180-Min Post-Breakfast | 1.0 percentage of systolic peak | Standard Deviation 5.5 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 120-Min Post-Breakfast | -2.9 percentage of systolic peak | Standard Deviation 4.45 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 120-Min Post-Breakfast | -2.3 percentage of systolic peak | Standard Deviation 6.8 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 60-Min Post-Breakfast | -2.5 percentage of systolic peak | Standard Deviation 7 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 240-Min Post-Breakfast | -0.6 percentage of systolic peak | Standard Deviation 6.34 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in Pulse Wave Amplitude (PWA) | 180-Min Post-Breakfast | -1.1 percentage of systolic peak | Standard Deviation 7.28 |
p-value: 0.02495% CI: [-6.5, -0.48]ANCOVA
p-value: 0.85995% CI: [-2.59, 3.09]ANCOVA
p-value: 0.15595% CI: [-5.25, 0.87]ANCOVA
p-value: 0.68595% CI: [-3.46, 2.3]ANCOVA
p-value: 0.29295% CI: [-5.33, 1.64]ANCOVA
p-value: 0.21695% CI: [-1.25, 5.33]ANCOVA
p-value: 0.06595% CI: [-5.92, 0.18]ANCOVA
p-value: 0.95495% CI: [-2.96, 2.8]ANCOVA
Secondary
Change in QT Interval on Electrocardiogram (ECG)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (High Postprandial Glucose) | 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 |
| T2DM Overall (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 120-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 18.0 milliseconds (msec) | Standard Deviation 75.72 |
| T2DM Overall (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 60-Min Post-Breakfast (n=25, 20, 21, 24, 24) | 23.8 milliseconds (msec) | Standard Deviation 81 |
| T2DM Overall (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 240-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 18.5 milliseconds (msec) | Standard Deviation 75.04 |
| T2DM Overall (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 180-Min Post-Breakfast (n=25, 21, 21, 23 ,24) | 19.1 milliseconds (msec) | Standard Deviation 77.11 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 180-Min Post-Breakfast (n=25, 21, 21, 23 ,24) | 5.8 milliseconds (msec) | Standard Deviation 7.45 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 120-Min Post-Breakfast (n=25, 21, 21, 24, 24) | -0.8 milliseconds (msec) | Standard Deviation 5.74 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 240-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 7.2 milliseconds (msec) | Standard Deviation 7.63 |
| T2DM With Albuminuria (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 60-Min Post-Breakfast (n=25, 20, 21, 24, 24) | 6.5 milliseconds (msec) | Standard Deviation 9.12 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 120-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 1.4 milliseconds (msec) | Standard Deviation 9.84 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 240-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 5.0 milliseconds (msec) | Standard Deviation 9.67 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 60-Min Post-Breakfast (n=25, 20, 21, 24, 24) | 11.0 milliseconds (msec) | Standard Deviation 10.47 |
| T2DM With Albuminuria (Low Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 180-Min Post-Breakfast (n=25, 21, 21, 23 ,24) | 2.5 milliseconds (msec) | Standard Deviation 9.8 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 180-Min Post-Breakfast (n=25, 21, 21, 23 ,24) | 4.5 milliseconds (msec) | Standard Deviation 10.24 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 120-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 2.8 milliseconds (msec) | Standard Deviation 10.89 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 60-Min Post-Breakfast (n=25, 20, 21, 24, 24) | 11.3 milliseconds (msec) | Standard Deviation 14.73 |
| T2DM With Normal UAER (High Postprandial Glucose) | Change in QT Interval on Electrocardiogram (ECG) | 240-Min Post-Breakfast (n=25, 21, 21, 24, 24) | 5.6 milliseconds (msec) | Standard Deviation 11.87 |