Trial Outcomes & Findings for Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus (NCT NCT01947855)
NCT ID: NCT01947855
Last Updated: 2014-12-24
Results Overview
The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28
Results posted on
2014-12-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
|
Empagliflozin 10 mg
Empagliflozin 10 mg oral administration once daily
|
Empagliflozin 25 mg
Empagliflozin 25mg oral administration once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
|
Empagliflozin 10 mg
Empagliflozin 10 mg oral administration once daily
|
Empagliflozin 25 mg
Empagliflozin 25mg oral administration once daily
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
|
Empagliflozin 10 mg
n=20 Participants
Empagliflozin 10 mg oral administration once daily
|
Empagliflozin 25 mg
n=19 Participants
Empagliflozin 25mg oral administration once daily
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28Population: Full analysis set
The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
|
Empagliflozin 10 mg
n=20 Participants
Empagliflozin 10 mg oral administration once daily
|
Empagliflozin 25 mg
n=19 Participants
Empagliflozin 25mg oral administration once daily
|
|---|---|---|---|
|
Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment
|
-18.07 mg*h/dL
Standard Error 13.89
|
-103.56 mg*h/dL
Standard Error 14.24
|
-122.94 mg*h/dL
Standard Error 14.35
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Empagliflozin 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
|
Empagliflozin 10 mg
n=20 participants at risk
Empagliflozin 10 mg oral administration once daily
|
Empagliflozin 25 mg
n=19 participants at risk
Empagliflozin 25mg oral administration once daily
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
10.0%
2/20 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
0.00%
0/19 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/21 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
0.00%
0/20 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
5.3%
1/19 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/21 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
0.00%
0/20 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
5.3%
1/19 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/21 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
0.00%
0/20 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
5.3%
1/19 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/21 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
0.00%
0/20 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
5.3%
1/19 • between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days
|
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 Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER