Trial Outcomes & Findings for A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects (NCT NCT01248364)

NCT ID: NCT01248364

Last Updated: 2014-09-09

Results Overview

Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 91 participants
• Primary outcome timeframe: Baseline and day 1
• Results posted on: 2014-09-09

Participant Flow

Participant milestones

Measure	T2DM Naive Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Study STARTED	32	34	13	12
Overall Study Completed Acute Phase:Single Dose, Day 1	32	34	13	12
Overall Study Completed Chronic Phase:28-day Treatment	32	33	13	0
Overall Study COMPLETED	32	33	13	12
Overall Study NOT COMPLETED	0	1	0	0

Reasons for withdrawal

Measure	T2DM Naive Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Study Adverse Event	0	1	0	0

Baseline Characteristics

A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects

Baseline characteristics by cohort

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=12 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.	Total n=91 Participants Total of all reporting groups
Age, Continuous	60.1 years STANDARD_DEVIATION 7.0 • n=5 Participants	63.3 years STANDARD_DEVIATION 6.5 • n=7 Participants	50.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	47.7 years STANDARD_DEVIATION 2.3 • n=4 Participants	58.3 years STANDARD_DEVIATION 8.9 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	28 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	63 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and day 1

Population: Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))

Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=12 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Fasting Plasma Glucose at Day 1	0.20 mmol/L Standard Error 0.12	0.39 mmol/L Standard Error 0.13	-0.96 mmol/L Standard Error 0.86	-0.47 mmol/L Standard Error 0.97

PRIMARY outcome

Timeframe: Baseline and day 28

Population: Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit

Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.

Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=33 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Fasting Plasma Glucose at Day 28	-1.02 mmol/L Standard Error 0.13	-0.79 mmol/L Standard Error 0.15	-0.81 mmol/L Standard Error 1.12	—

PRIMARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1

Population: Treated set (OR)

Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=11 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1	-1.94 g/dL/h Standard Error 0.53	-3.52 g/dL/h Standard Error 0.61	-5.49 g/dL/h Standard Error 1.95	-9.20 g/dL/h Standard Error 3.91

PRIMARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28

Population: Treated set (OR) for patients who completed the day 28 visit

Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.

Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=33 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28	-0.71 g/dL/h Standard Error 0.67	-0.40 g/dL/h Standard Error 0.72	-7.31 g/dL/h Standard Error 2.91	—

SECONDARY outcome

Timeframe: Baseline and day 1

Population: Treated set (OR)

Change from baseline in rate of endogenous glucose production (EGP) fast after one dose

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=12 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1	4.21 umol/kgFFM/min Standard Error 0.45	4.51 umol/kgFFM/min Standard Error 0.60	3.28 umol/kgFFM/min Standard Error 0.89	1.10 umol/kgFFM/min Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline and day 28

Population: Treated set (OR) for patients who completed the day 28 visit

Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.

Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=33 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28	2.79 umol/kgFFM/min Standard Error 0.71	4.63 umol/kgFFM/min Standard Error 0.86	1.47 umol/kgFFM/min Standard Error 1.44	—

SECONDARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1

Population: Treated set (OR)

Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=11 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1	3.28 g Standard Error 1.80	8.76 g Standard Error 1.77	3.70 g Standard Error 2.73	9.22 g Standard Error 3.94

SECONDARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28

Population: Treated set (OR) for patients who completed the day 28 visit

Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.

Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=33 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28	1.89 g Standard Error 1.35	5.02 g Standard Error 1.33	3.14 g Standard Error 2.35	—

SECONDARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1

Population: Treated set (OR)

Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=11 Participants Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1	-8.52 g Standard Error 1.79	-7.22 g Standard Error 2.33	-3.75 g Standard Error 3.82	1.28 g Standard Error 4.80

SECONDARY outcome

Timeframe: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28

Population: Treated set (OR) for patients who completed the day 28 visit

Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.

Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable.

Outcome measures

Measure	T2DM Naive n=32 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=33 Participants Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 Participants Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28	-6.95 g Standard Error 2.26	-10.63 g Standard Error 2.50	-0.49 g Standard Error 5.22	—

Adverse Events

T2DM Naive

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

T2DM Metformin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Impaired Glucose Tolerance

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	T2DM Naive n=32 participants at risk Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 participants at risk Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 participants at risk Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=12 participants at risk Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
Cardiac disorders Myocardial infarction	0.00% 0/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	2.9% 1/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks

Other adverse events

Measure	T2DM Naive n=32 participants at risk Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	T2DM Metformin n=34 participants at risk Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Impaired Glucose Tolerance n=13 participants at risk Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.	Healthy Subjects n=12 participants at risk Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
Infections and infestations Nasopharyngitis	6.2% 2/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	2.9% 1/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	7.7% 1/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	8.3% 1/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Infections and infestations Respiratory tract infection	0.00% 0/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	7.7% 1/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Nervous system disorders Headache	6.2% 2/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	2.9% 1/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Nervous system disorders Dizziness	6.2% 2/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	7.7% 1/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Gastrointestinal disorders Diarrhoea	6.2% 2/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	2.9% 1/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	7.7% 1/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
General disorders Fatigue	0.00% 0/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	7.7% 1/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks
General disorders Thirst	3.1% 1/32 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	5.9% 2/34 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/13 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks	0.00% 0/12 • From first intake of study drug until 7 days after the last treatment intake, 5 weeks

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

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.
• Publication restrictions are in place

Restriction type: OTHER