Trial Outcomes & Findings for Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA (NCT NCT02589626)
NCT ID: NCT02589626
Last Updated: 2019-01-07
Results Overview
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
52 weeks
Results posted on
2019-01-07
Participant Flow
Patients were entered in the trial and randomised in a 1:1 ratio to receive treatment.
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist site which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not randomised to trial treatment if any one of the specific entry criteria was violated.
Participant milestones
| Measure |
Empagliflozin 10 mg
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25 mg
Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Empagliflozin 10 mg
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25 mg
Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
|
|---|---|---|
|
Overall Study
Other than the reason specified
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Full analysis set The full analysis set (FAS) consisted of all patients in the TS who were treated with at least 1 dose of the randomised study drug and had a baseline HbA1c assessment. The assignment of patients to treatment groups was based on the randomised study drug at time of randomisation.
Baseline characteristics by cohort
| Measure |
Empagliflozin 10 mg
n=32 Participants
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25 mg
n=33 Participants
Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants • Full analysis set The full analysis set (FAS) consisted of all patients in the TS who were treated with at least 1 dose of the randomised study drug and had a baseline HbA1c assessment. The assignment of patients to treatment groups was based on the randomised study drug at time of randomisation.
|
58.9 years
STANDARD_DEVIATION 9.3 • n=7 Participants • Full analysis set The full analysis set (FAS) consisted of all patients in the TS who were treated with at least 1 dose of the randomised study drug and had a baseline HbA1c assessment. The assignment of patients to treatment groups was based on the randomised study drug at time of randomisation.
|
57.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants • Full analysis set The full analysis set (FAS) consisted of all patients in the TS who were treated with at least 1 dose of the randomised study drug and had a baseline HbA1c assessment. The assignment of patients to treatment groups was based on the randomised study drug at time of randomisation.
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • FAS
|
11 Participants
n=7 Participants • FAS
|
17 Participants
n=5 Participants • FAS
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants • FAS
|
22 Participants
n=7 Participants • FAS
|
48 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants • FAS
|
33 Participants
n=7 Participants • FAS
|
65 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • FAS
|
0 Participants
n=7 Participants • FAS
|
0 Participants
n=5 Participants • FAS
|
|
Baseline glycosylated haemoglobin A1c (HbA1c)
|
8.83 % of HbA1c
STANDARD_DEVIATION 0.80 • n=5 Participants • FAS
|
8.68 % of HbA1c
STANDARD_DEVIATION 0.87 • n=7 Participants • FAS
|
8.76 % of HbA1c
STANDARD_DEVIATION 0.83 • n=5 Participants • FAS
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of the study drug. The assignment of patients to treatment group was based on the first study drug intake in the double-blind treatment period.
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
Outcome measures
| Measure |
Empagliflozin 10 mg
n=32 Participants
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25 mg
n=33 Participants
Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
|
|---|---|---|
|
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
|
9.4 Percentage of participants
|
21.2 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 52 weeksPopulation: Full Analysis Set (Observed cases (OC))
Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=32 Participants
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25 mg
n=33 Participants
Patients were orally administered film-coated tablet of Empagliflozin 25 mg once daily in the morning for 52 weeks
|
|---|---|---|
|
Change From Baseline in HbA1c After 52 Weeks of Treatment
|
-0.55 % of HbA1c
Standard Deviation 0.15
|
-0.77 % of HbA1c
Standard Deviation 0.14
|
Adverse Events
Empagliflozin 10 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Empagliflozin 25mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Empagliflozin 10 mg
n=32 participants at risk
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25mg
n=33 participants at risk
Patients were orally administered film-coated tablet of Empagliflozin 10 mg once in the morning for 52 weeks
|
|---|---|---|
|
Nervous system disorders
Loss of consciousness
|
3.1%
1/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
0.00%
0/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
3.0%
1/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
3.1%
1/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
0.00%
0/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
Other adverse events
| Measure |
Empagliflozin 10 mg
n=32 participants at risk
Patients were orally administered film-coated tablet of Empagliflozin 10 milligram (mg) once daily in the morning for 52 weeks
|
Empagliflozin 25mg
n=33 participants at risk
Patients were orally administered film-coated tablet of Empagliflozin 10 mg once in the morning for 52 weeks
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
31.2%
10/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
33.3%
11/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
9.1%
3/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Infections and infestations
Periodontitis
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
6.1%
2/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
6.1%
2/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
6.1%
2/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
6.1%
2/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
1/32 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
6.1%
2/33 • All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks
|
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 right
- Publication restrictions are in place
Restriction type: OTHER