Trial Outcomes & Findings for Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus (NCT NCT02702011)
NCT ID: NCT02702011
Last Updated: 2018-04-02
Results Overview
Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline and 7 days
Results posted on
2018-04-02
Participant Flow
Participant milestones
| Measure |
Placebo
Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 2.5 mg
Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
|
Empagliflozin 10 mg
Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 25 mg
Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 2.5 mg
Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
|
Empagliflozin 10 mg
Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 25 mg
Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 2.5 mg
n=13 Participants
Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
|
Empagliflozin 10 mg
n=12 Participants
Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 25 mg
n=12 Participants
Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
46.6 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
44.8 Years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 daysPopulation: The primary analysis was performed on the FAS with last observation carried forward (LOCF) imputation.
Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.
Outcome measures
| Measure |
Placebo
n=11 Participants
Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 2.5 mg
n=13 Participants
Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
|
Empagliflozin 10 mg
n=12 Participants
Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 25 mg
n=12 Participants
Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
|---|---|---|---|---|
|
Change From Baseline in 24 Hour UGE on Day 7
|
-0.46 gram per 24 hours (g/24 h)
Standard Error 7.96
|
64.63 gram per 24 hours (g/24 h)
Standard Error 7.31
|
80.73 gram per 24 hours (g/24 h)
Standard Error 7.68
|
97.64 gram per 24 hours (g/24 h)
Standard Error 7.63
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Empagliflozin 2.5 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Empagliflozin 25 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Oral administration of matching placebo of 2.5 mg, 10 mg and 25 mg of empagliflozin film-coated tablets once daily during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 2.5 mg
n=13 participants at risk
Oral administration of 2.5 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 10 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period
|
Empagliflozin 10 mg
n=12 participants at risk
Oral administration of 10 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 25 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
Empagliflozin 25 mg
n=12 participants at risk
Oral administration of 25 milligram (mg) of empagliflozin film-coated tablets once daily along with one matching placebo each of 2.5 mg and 10 mg of empagliflozin during the 28 days randomized double-blinded treatment period.
|
|---|---|---|---|---|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
7.7%
1/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
100.0%
11/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
92.3%
12/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
100.0%
12/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
100.0%
12/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
7.7%
1/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
7.7%
1/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue inflammation
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
8.3%
1/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Nervous system disorders
Dizziness postural
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Gastrointestinal disorders
Faeces soft
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/13 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
0.00%
0/12 • From first drug administration till 7 days after last drug intake; up to 35 days
Treated set (TS): This analysis set included all patients treated with at least one dose of randomised study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
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