Trial Outcomes & Findings for Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation) (NCT NCT01703286)
NCT ID: NCT01703286
Last Updated: 2015-01-19
Results Overview
Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
baseline and day 28 for each treatment arm
Results posted on
2015-01-19
Participant Flow
Participant milestones
| Measure |
Pbo/ G1-4/ L 5
Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
|
L 5/ G 1-4/ Pbo
Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
|
G 1-4/ L 5/ Pbo
Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
|
G1-4/ Pbo/ L 5
Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
|
Pbo/ L 5/ G1-4
Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
L 5/ Pbo/ G1-4/
Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
|---|---|---|---|---|---|---|
|
Period 1 Including Washout
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
Period 1 Including Washout
COMPLETED
|
7
|
7
|
7
|
6
|
7
|
6
|
|
Period 1 Including Washout
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Period 2 Including Washout
STARTED
|
7
|
7
|
7
|
6
|
7
|
6
|
|
Period 2 Including Washout
COMPLETED
|
7
|
7
|
7
|
5
|
7
|
6
|
|
Period 2 Including Washout
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 3 Including Washout
STARTED
|
7
|
7
|
7
|
5
|
7
|
6
|
|
Period 3 Including Washout
COMPLETED
|
7
|
7
|
7
|
5
|
7
|
6
|
|
Period 3 Including Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pbo/ G1-4/ L 5
Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
|
L 5/ G 1-4/ Pbo
Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
|
G 1-4/ L 5/ Pbo
Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
|
G1-4/ Pbo/ L 5
Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
|
Pbo/ L 5/ G1-4
Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
L 5/ Pbo/ G1-4/
Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
|---|---|---|---|---|---|---|
|
Period 1 Including Washout
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Period 2 Including Washout
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
Baseline characteristics by cohort
| Measure |
Total Participants
n=42 Participants
All study participants
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 6.0 • n=39 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: baseline and day 28 for each treatment armPopulation: Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.
Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Outcome measures
| Measure |
Linagliptin 5 mg
n=39 Participants
Linagliptin: 1 tablet (5 mg) once daily for 28 days
|
Glimepiride 1-4 mg
n=41 Participants
Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
Placebo
n=39 Participants
Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
|
REP - Linagliptin 5 mg
Residual effect period - Linagliptin 5 mg
|
REP - Glimepiride 1-4 mg
Residual effect period - Glimepiride 1-4 mg
|
Rep - Placebo
Residual effect period - Placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28
|
0.885 percentage
Interval 0.695 to 1.128
|
1.002 percentage
Interval 0.795 to 1.262
|
1.002 percentage
Interval 0.786 to 1.277
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and day 28 for each treatment armEndothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Outcome measures
| Measure |
Linagliptin 5 mg
n=38 Participants
Linagliptin: 1 tablet (5 mg) once daily for 28 days
|
Glimepiride 1-4 mg
n=41 Participants
Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
Placebo
n=39 Participants
Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
|
REP - Linagliptin 5 mg
Residual effect period - Linagliptin 5 mg
|
REP - Glimepiride 1-4 mg
Residual effect period - Glimepiride 1-4 mg
|
Rep - Placebo
Residual effect period - Placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28
|
1.262 Percentage
Interval 0.968 to 1.646
|
1.045 Percentage
Interval 0.815 to 1.339
|
1.009 Percentage
Interval 0.777 to 1.311
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and day 28 for each treatment armPopulation: Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.
Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
Outcome measures
| Measure |
Linagliptin 5 mg
n=39 Participants
Linagliptin: 1 tablet (5 mg) once daily for 28 days
|
Glimepiride 1-4 mg
n=41 Participants
Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
Placebo
n=39 Participants
Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
|
REP - Linagliptin 5 mg
Residual effect period - Linagliptin 5 mg
|
REP - Glimepiride 1-4 mg
Residual effect period - Glimepiride 1-4 mg
|
Rep - Placebo
Residual effect period - Placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28
|
1.003 percentage
Interval 0.945 to 1.061
|
1.053 percentage
Interval 0.998 to 1.108
|
0.981 percentage
Interval 0.923 to 1.039
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 20 weeksPopulation: Treated set (TS)
Number of patients with any adverse events
Outcome measures
| Measure |
Linagliptin 5 mg
n=40 Participants
Linagliptin: 1 tablet (5 mg) once daily for 28 days
|
Glimepiride 1-4 mg
n=41 Participants
Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
Placebo
n=40 Participants
Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
|
REP - Linagliptin 5 mg
n=40 Participants
Residual effect period - Linagliptin 5 mg
|
REP - Glimepiride 1-4 mg
n=41 Participants
Residual effect period - Glimepiride 1-4 mg
|
Rep - Placebo
n=40 Participants
Residual effect period - Placebo
|
|---|---|---|---|---|---|---|
|
Number of Patients With Adverse Events
|
11 participants
|
25 participants
|
14 participants
|
4 participants
|
7 participants
|
7 participants
|
Adverse Events
Linagliptin 5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Glimepiride 1-4 mg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Linagliptin 5 mg
n=40 participants at risk
Linagliptin: 1 tablet (5 mg) once daily for 28 days
|
Glimepiride 1-4 mg
n=41 participants at risk
Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
|
Placebo
n=40 participants at risk
Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
14.6%
6/41 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
7.5%
3/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.0%
2/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
39.0%
16/41 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
2.5%
1/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
7.3%
3/41 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
15.0%
6/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
7.3%
3/41 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
0.00%
0/40 • 28 days treatment period + 7 days residual effect period
The adverse events occurred during residual effect period (REP) were included in the frequencies.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER