Trial Outcomes & Findings for Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes (NCT NCT01177813)

NCT ID: NCT01177813

Last Updated: 2014-06-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

986 participants

Primary outcome timeframe

Baseline and day 169

Results posted on

2014-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
Overall Study STARTED	228	224	224	223	87
Overall Study COMPLETED	187	206	204	206	78
Overall Study NOT COMPLETED	41	18	20	17	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
Overall Study Adverse Event	8	2	4	6	3
Overall Study Lack of Efficacy	1	0	0	0	0
Overall Study Protocol Violation	3	2	2	0	1
Overall Study Lost to Follow-up	12	5	6	3	0
Overall Study Withdrawal by Subject	12	7	6	5	3
Overall Study Other reason not defined above	5	2	2	3	2

Baseline Characteristics

Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=228 Participants Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 Participants Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=224 Participants Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 n=223 Participants Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 Participants Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.	Total n=986 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	56.2 years STANDARD_DEVIATION 11.6 • n=7 Participants	53.8 years STANDARD_DEVIATION 11.6 • n=5 Participants	55.1 years STANDARD_DEVIATION 9.9 • n=4 Participants	50.2 years STANDARD_DEVIATION 11.3 • n=21 Participants	55.0 years STANDARD_DEVIATION 11.0 • n=8 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	82 Participants n=7 Participants	79 Participants n=5 Participants	82 Participants n=4 Participants	23 Participants n=21 Participants	371 Participants n=8 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	142 Participants n=7 Participants	145 Participants n=5 Participants	141 Participants n=4 Participants	64 Participants n=21 Participants	615 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and day 169

Population: FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 Participants Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=224 Participants Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 Participants Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 Participants Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks	0.06 percent of HbA1c Standard Error 0.05	-0.66 percent of HbA1c Standard Error 0.06	-0.77 percent of HbA1c Standard Error 0.06	-0.65 percent of HbA1c Standard Error 0.05	-3.10 percent of HbA1c Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline and day 169

Population: FAS (LOCF) and open-label set (LOCF)

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 Participants Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=224 Participants Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 Participants Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 Participants Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Change From Baseline to Week 24 in Body Weight	-0.33 kg Standard Error 0.15	-2.26 kg Standard Error 0.19	-2.48 kg Standard Error 0.18	0.17 kg Standard Error 0.18	-1.93 kg Standard Error 0.44

SECONDARY outcome

Timeframe: Baseline and week 24

Population: FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm). In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive. For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.

Outcome measures

Outcome measures
Measure	Placebo n=228 Participants Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 Participants Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=224 Participants Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 Participants Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 Participants Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) Systolic blood pressure	0.0 mmHg Standard Error 0.8	-3.5 mmHg Standard Error 1.0	-3.2 mmHg Standard Error 0.9	0.2 mmHg Standard Error 0.9	-3.8 mmHg Standard Error 1.2
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP) Diastolic blood pressure	-0.4 mmHg Standard Error 0.5	-1.1 mmHg Standard Error 0.6	-1.7 mmHg Standard Error 0.5	0.4 mmHg Standard Error 0.5	-1.5 mmHg Standard Error 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From first drug intake until 7 days after last medication intake, up to 219 days

Population: Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set

Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value \<= 70 ml/dL or where assistance was required. Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.

Outcome measures

Outcome measures
Measure	Placebo n=229 Participants Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 Participants Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=223 Participants Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 Participants Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 Participants Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Confirmed Hypoglycaemic Adverse Events Symptomatic hypoglycaemic adverse events	0.4 percentage of participants	0.4 percentage of participants	0.4 percentage of participants	0.4 percentage of participants	0 percentage of participants
Confirmed Hypoglycaemic Adverse Events Asymptomatic hypoglycaemic adverse events	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 63 other events

Deaths: 0 deaths

Empagliflozin10 mg

Serious events: 8 serious events

Other events: 45 other events

Deaths: 0 deaths

Empagliflozin 25 mg

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Sitagliptin 100 mg

Serious events: 6 serious events

Other events: 44 other events

Deaths: 0 deaths

Empagliflozin 25 mg OL

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=229 participants at risk Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 participants at risk Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=223 participants at risk Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 participants at risk Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 participants at risk Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
Infections and infestations Herpes virus infection	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Endocrine disorders Goitre	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Metabolism and nutrition disorders Hyperglycaemia	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Nervous system disorders Diabetic neuropathy	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.1% 1/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Nervous system disorders Cerebrovascular accident	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Nervous system disorders Ischaemic stroke	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Nervous system disorders Transient ischaemic attack	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Eye disorders Cataract	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Cardiac disorders Angina unstable	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.1% 1/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Cardiac disorders Acute myocardial infarction	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Cardiac disorders Atrial fibrillation	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Cardiac disorders Myocardial infarction	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Gastrointestinal disorders Colonic polyp	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Gastrointestinal disorders Haemorrhoids	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Hepatobiliary disorders Cholecystitis	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Hepatobiliary disorders Cholecystitis acute	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Hepatobiliary disorders Liver disorder	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Reproductive system and breast disorders Breast mass	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Congenital, familial and genetic disorders Gilbert's syndrome	0.44% 1/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
General disorders Hernia	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.1% 1/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Injury, poisoning and procedural complications Animal bite	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Injury, poisoning and procedural complications Injury	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.45% 1/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	0.00% 0/87 • From first drug administration until seven days after last trial medication intake, up to 219 days

Other adverse events

Other adverse events
Measure	Placebo n=229 participants at risk Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.	Empagliflozin10 mg n=224 participants at risk Patients receive 10 mg Empagliflozin in tablets once daily in the morning.	Empagliflozin 25 mg n=223 participants at risk Patients receive 25 mg Empagliflozin in tablets once daily in the morning.	Sitagliptin 100 mg n=223 participants at risk Patients receive 100 mg Sitagliptin in tablets once daily in the morning.	Empagliflozin 25 mg OL n=87 participants at risk Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
Infections and infestations Urinary tract infection	3.9% 9/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	6.2% 14/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	3.6% 8/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	4.9% 11/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	3.4% 3/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Metabolism and nutrition disorders Hyperglycaemia	15.3% 35/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	2.2% 5/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.8% 4/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	5.8% 13/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	16.1% 14/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Infections and infestations Nasopharyngitis	7.4% 17/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	7.1% 16/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	4.9% 11/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	6.7% 15/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.1% 1/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Metabolism and nutrition disorders Dyslipidaemia	4.4% 10/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	5.8% 13/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	4.5% 10/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	2.7% 6/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	8.0% 7/87 • From first drug administration until seven days after last trial medication intake, up to 219 days
Gastrointestinal disorders Diarrhoea	1.3% 3/229 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.8% 4/224 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.3% 3/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	1.3% 3/223 • From first drug administration until seven days after last trial medication intake, up to 219 days	6.9% 6/87 • From first drug administration until seven days after last trial medication intake, up to 219 days

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER