Trial Outcomes & Findings for 24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension (NCT NCT02182830)

NCT ID: NCT02182830

Last Updated: 2018-07-31

Results Overview

Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 166 participants
• Primary outcome timeframe: baseline and 24 weeks
• Results posted on: 2018-07-31

Participant Flow

In this Phase 3b, multi-centre trial, a total of 719 patients were screened by 92 centres across the United States. The first centre was initiated on 25 Jul 2014. Of the 719 screened patients, 297 patients entered the placebo run-in phase of the trial and 166 were subsequently randomised to double-blind treatment

Empagliflozin was administered at a starting dose of 10 milligram (mg) once daily. At Week 4, patients were dose escalated to a dose of 25 mg once daily. These doses were selected based on the results from previous dose-finding studies

Participant milestones

Measure	Placebo Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Study STARTED	83	83
Overall Study Randomised Set (RS)	79	82
Overall Study Treated Set (TS)	77	80
Overall Study COMPLETED	68	68
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Measure	Placebo Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Overall Study Not Treated	1	1
Overall Study Trial stopped, reason missing	3	3
Overall Study Consent withdrawn	8	8
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. The FAS was the basis for the primary efficacy analysis.

Baseline characteristics by cohort

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)	Total n=150 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 9.3 • n=5 Participants • Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. The FAS was the basis for the primary efficacy analysis.	56.5 years STANDARD_DEVIATION 9.3 • n=7 Participants • Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. The FAS was the basis for the primary efficacy analysis.	56.8 years STANDARD_DEVIATION 9.3 • n=5 Participants • Full analysis set (FAS): All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. The FAS was the basis for the primary efficacy analysis.
Sex: Female, Male Female	36 Participants n=5 Participants • FAS	35 Participants n=7 Participants • FAS	71 Participants n=5 Participants • FAS
Sex: Female, Male Male	36 Participants n=5 Participants • FAS	43 Participants n=7 Participants • FAS	79 Participants n=5 Participants • FAS
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • FAS	0 Participants n=7 Participants • FAS	0 Participants n=5 Participants • FAS
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants • FAS	78 Participants n=7 Participants • FAS	150 Participants n=5 Participants • FAS
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • FAS	0 Participants n=7 Participants • FAS	0 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	0 Participants n=5 Participants • FAS	0 Participants n=7 Participants • FAS	0 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	72 Participants n=5 Participants • FAS	78 Participants n=7 Participants • FAS	150 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 hemoglobin A1c (HbA1c) [%]	8.51 percentage of HbA1c STANDARD_DEVIATION 1.12 • n=5 Participants • FAS	8.66 percentage of HbA1c STANDARD_DEVIATION 0.92 • n=7 Participants • FAS	8.59 percentage of HbA1c STANDARD_DEVIATION 1.02 • n=5 Participants • FAS
Baseline estimated glomerular filtration rate (eGFR)	91.49 mL/min/1.73m² STANDARD_DEVIATION 20.79 • n=5 Participants • FAS	91.15 mL/min/1.73m² STANDARD_DEVIATION 18.95 • n=7 Participants • FAS	91.31 mL/min/1.73m² STANDARD_DEVIATION 19.79 • n=5 Participants • FAS

PRIMARY outcome

Timeframe: baseline and 24 weeks

Population: Full analysis set (FAS) observed cases (OC); FAS: All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value. Observed cases will set all values measured after antidiabetic rescue medication to missing

Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks	0.07 percentage of glycated haemoglobin Standard Error 0.14	-0.71 percentage of glycated haemoglobin Standard Error 0.14

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: FAS LOCF-H; LOCF-H= Last observation carried forward without values following antidiabetic rescue medication and/or a change in antihypertensive therapy

Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12	-0.90 millimeter of mercury (mmHg) Standard Error 1.47	-6.10 millimeter of mercury (mmHg) Standard Error 1.41

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: FAS LOCF-H

Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Changes From Baseline in Trough Mean Ambulatory SBP at Week 12	-1.00 millimeter of mercury (mmHg) Standard Error 1.89	-6.99 millimeter of mercury (mmHg) Standard Error 1.80

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: FAS OC

Changes from baseline in body weight at Week 24 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Body Weight at Week 24	-0.98 kilogram (kg) Standard Error 0.42	-2.21 kilogram (kg) Standard Error 0.41

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means. This is a key secondary endpoint

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Trough Seated SBP at Week 12	-3.94 mmHg Standard Error 1.82	-7.97 mmHg Standard Error 1.83

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24	-1.94 mmHg Standard Error 1.94	-10.33 mmHg Standard Error 1.85

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: FAS (LOCF-H)

Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12	-0.37 mmHg Standard Error 0.90	-3.80 mmHg Standard Error 0.86

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24	-1.48 mmHg Standard Error 1.24	-6.38 mmHg Standard Error 1.20

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Trough Seated SBP (mmHg) at Week 24	-2.83 mmHg Standard Error 1.82	-10.26 mmHg Standard Error 1.70

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Trough Seated DBP (mmHg) at Week 12	-2.30 mmHg Standard Error 1.09	-4.14 mmHg Standard Error 1.10

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)

Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term "baseline" refers to the last observation prior to randomisation of the patient.

Means presented are the adjusted means.

Outcome measures

Measure	Placebo n=72 Participants Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=78 Participants Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Change From Baseline in Trough Seated DBP (mmHg) at Week 24	-1.30 mmHg Standard Error 1.09	-5.55 mmHg Standard Error 1.02

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Empagliflozin 10 Mg-25mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=77 participants at risk；n=80 participants at risk Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=80 participants at risk；n=82 participants at risk Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Cardiac disorders Cardiac failure congestive	0.00% 0/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	1.2% 1/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
General disorders Chest pain	1.2% 1/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	1.2% 1/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	1.2% 1/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Injury, poisoning and procedural complications Overdose	0.00% 0/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	1.2% 1/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.2% 1/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	0.00% 0/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Nervous system disorders Cerebrovascular accident	1.2% 1/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	0.00% 0/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Respiratory, thoracic and mediastinal disorders Asthma	1.2% 1/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	0.00% 0/82 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.

Other adverse events

Measure	Placebo n=77 participants at risk；n=80 participants at risk Patients were orally administered Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily, morning)	Empagliflozin 10 Mg-25mg n=80 participants at risk；n=82 participants at risk Patients were orally administered Empagliflozin 10 mg or 25mg (1 tablet once daily, morning over a period of 24 weeks)
Investigations Lipase increased	3.9% 3/77 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	7.5% 6/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/77 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	6.2% 5/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.
Infections and infestations Upper respiratory tract infection	5.2% 4/77 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.	2.5% 2/80 • All adverse events occurring after the first dose of trial medication up to a period of 7 days after the last dose of trial medication (i.e. end of REP); up to 25 weeks All the safety analyses were based on treated set except the serious adverse event analysis. The two patients with multiple participation in the study (counted once as first randomized) and three patients excluded from one site were included back into treated set for the analysis of serious adverse event.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

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.
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Restriction type: OTHER