Trial Outcomes & Findings for Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema (NCT NCT02732951)
NCT ID: NCT02732951
Last Updated: 2019-03-20
Results Overview
The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2019-03-20
Participant Flow
This was randomised, double-blind, placebo-controlled, parallel-group trial to evaluate pharmacodynamics, safety and tolerability of orally administered Boehringer Ingelheim (BI) 1026706 for 12 weeks in patients with Diabetic Macular Oedema (DME).
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.
Participant milestones
| Measure |
Placebo Matching to BI 1026706
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
48
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Placebo Matching to BI 1026706
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Overall Study
Other than listed
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
Placebo Matching to BI 1026706
n=53 Participants
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
n=52 Participants
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 Years
STANDARD_DEVIATION 9.7 • n=93 Participants • TS
|
63.9 Years
STANDARD_DEVIATION 8.7 • n=4 Participants • TS
|
63.0 Years
STANDARD_DEVIATION 9.2 • n=27 Participants • TS
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants • TS
|
14 Participants
n=4 Participants • TS
|
28 Participants
n=27 Participants • TS
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants • TS
|
38 Participants
n=4 Participants • TS
|
77 Participants
n=27 Participants • TS
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants • TS
|
4 Participants
n=4 Participants • TS
|
8 Participants
n=27 Participants • TS
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=93 Participants • TS
|
43 Participants
n=4 Participants • TS
|
78 Participants
n=27 Participants • TS
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants • TS
|
5 Participants
n=4 Participants • TS
|
19 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants • TS
|
0 Participants
n=4 Participants • TS
|
1 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
White
|
38 Participants
n=93 Participants • TS
|
47 Participants
n=4 Participants • TS
|
85 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • TS
|
0 Participants
n=4 Participants • TS
|
0 Participants
n=27 Participants • TS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants • TS
|
5 Participants
n=4 Participants • TS
|
19 Participants
n=27 Participants • TS
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set (FAS): FAS includes all patients who were randomised, treated with at least 1 dose of BI 1026706 or placebo, and with a baseline and at least one post randomisation central subfield foveal thickness (CSFT) measurement.
The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.
Outcome measures
| Measure |
Placebo Matching to BI 1026706
n=47 Participants
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
n=47 Participants
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12
|
-6.19 Micrometre [μm]
Standard Deviation 11.61
|
10.26 Micrometre [μm]
Standard Deviation 11.64
|
SECONDARY outcome
Timeframe: From first drug administration until 4 days after last drug administration, up to 89 days.Population: Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.
Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.
Outcome measures
| Measure |
Placebo Matching to BI 1026706
n=53 Participants
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
n=52 Participants
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Total with SAEs
|
2 Count of participants
|
7 Count of participants
|
|
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Investigator defined drug-related AE
|
7 Count of participants
|
7 Count of participants
|
|
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
0 Count of participants
|
1 Count of participants
|
Adverse Events
Placebo Matching to BI 1026706
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
BI 1026706
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Matching to BI 1026706
n=53 participants at risk
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
n=52 participants at risk
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Infections and infestations
Localised infection
|
1.9%
1/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
0.00%
0/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.9%
1/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
0.00%
0/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Skin and subcutaneous tissue disorders
Reactive perforating collagenosis
|
0.00%
0/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
Other adverse events
| Measure |
Placebo Matching to BI 1026706
n=53 participants at risk
Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.
|
BI 1026706
n=52 participants at risk
Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
3.8%
2/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
5.8%
3/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
4/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
11.5%
6/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.7%
3/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
0.00%
0/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Nervous system disorders
Headache
|
1.9%
1/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
7.7%
4/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
|
Nervous system disorders
Somnolence
|
5.7%
3/53 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
1.9%
1/52 • From first drug administration until 4 days after last drug administration, up to 89 days.
|
Additional Information
Boehringer Ingelheim, Call Centre
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