Trial Outcomes & Findings for Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment (NCT NCT01164501)

Last Updated: 2014-06-16

Results Overview

Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

741 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2014-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 10mg Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.	Empa 25mg Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Study STARTED	321	98	322
Overall Study COMPLETED	278	88	280
Overall Study NOT COMPLETED	43	10	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 10mg Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.	Empa 25mg Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Overall Study Not treated	2	0	1
Overall Study Adverse Event	18	4	21
Overall Study Lack of Efficacy	0	0	1
Overall Study Non compliant with protocol	1	1	4
Overall Study Lost to Follow-up	3	0	3
Overall Study Patient refusal to continue,not due toAE	10	4	8
Overall Study Other reason not defined above	9	1	4

Baseline Characteristics

Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=319 Participants Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 10mg n=98 Participants Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.	Empa 25mg n=321 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.	Total n=738 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 8.7 • n=93 Participants	63.2 years STANDARD_DEVIATION 8.5 • n=4 Participants	63.9 years STANDARD_DEVIATION 9.0 • n=27 Participants	63.9 years STANDARD_DEVIATION 8.8 • n=483 Participants
Sex: Female, Male Female	138 Participants n=93 Participants	38 Participants n=4 Participants	132 Participants n=27 Participants	308 Participants n=483 Participants
Sex: Female, Male Male	181 Participants n=93 Participants	60 Participants n=4 Participants	189 Participants n=27 Participants	430 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Population: Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.

Outcome measures

Outcome measures
Measure	Placebo n=282 Participants Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 25mg n=284 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.	Empa 25mg Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment	0.05 percentage of HbA1c Standard Error 0.04	-0.46 percentage of HbA1c Standard Error 0.04	—

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.

Outcome measures

Outcome measures
Measure	Placebo n=95 Participants Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 25mg n=98 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.	Empa 25mg n=97 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
HbA1c Change From Baseline in Patients With Mild Renal Impairment	0.06 percentage of HbA1c Standard Error 0.07	-0.46 percentage of HbA1c Standard Error 0.07	-0.63 percentage of HbA1c Standard Error 0.07

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.

Outcome measures

Outcome measures
Measure	Placebo n=187 Participants Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 25mg n=187 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.	Empa 25mg Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
HbA1c Change From Baseline in Patients With Moderate Renal Impairment	0.05 percentage of HbA1c Standard Error 0.05	-0.37 percentage of HbA1c Standard Error 0.05	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first drug administration until 7 days after last trial medication intake, up to 458 days

Population: Treated set which included all patients treated with at least one dose of randomised trial medication.

Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values \<= 70 mg/dL (\<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.

Outcome measures

Outcome measures
Measure	Placebo n=319 Participants Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 25mg n=98 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.	Empa 25mg n=321 Participants Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Hypoglycaemic Events	27.6 percentage of participants	26.5 percentage of participants	27.4 percentage of participants

Adverse Events

Placebo

Serious events: 44 serious events

Other events: 207 other events

Deaths: 0 deaths

Empa 10mg

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Empa 25mg

Serious events: 40 serious events

Other events: 187 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=319 participants at risk Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.	Empa 10mg n=98 participants at risk Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.	Empa 25mg n=321 participants at risk Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
Infections and infestations Balanitis candida	0.00% 0/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	5.1% 5/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	0.00% 0/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Infections and infestations Influenza	2.5% 8/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	6.1% 6/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	2.5% 8/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Infections and infestations Nasopharyngitis	9.1% 29/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	6.1% 6/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	8.4% 27/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Infections and infestations Upper respiratory tract infection	7.8% 25/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	14.3% 14/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	10.9% 35/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Infections and infestations Urinary tract infection	12.2% 39/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	14.3% 14/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	11.8% 38/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Metabolism and nutrition disorders Hyperglycaemia	12.9% 41/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	4.1% 4/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	7.2% 23/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Metabolism and nutrition disorders Hypoglycaemia	28.8% 92/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	27.6% 27/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	27.7% 89/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Musculoskeletal and connective tissue disorders Arthralgia	6.6% 21/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	7.1% 7/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	4.0% 13/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Musculoskeletal and connective tissue disorders Back pain	6.0% 19/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	8.2% 8/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	5.9% 19/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 10/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	8.2% 8/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	1.9% 6/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Nervous system disorders Headache	4.1% 13/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	5.1% 5/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	5.0% 16/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Respiratory, thoracic and mediastinal disorders Cough	7.8% 25/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	2.0% 2/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	3.4% 11/321 • From first drug administration until 7 days after last trial medication intake, up to 458 days
Vascular disorders Hypertension	6.3% 20/319 • From first drug administration until 7 days after last trial medication intake, up to 458 days	1.0% 1/98 • From first drug administration until 7 days after last trial medication intake, up to 458 days	4.4% 14/321 • From first drug administration until 7 days after last trial medication intake, up to 458 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