Trial Outcomes & Findings for Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes (NCT NCT01581658)

NCT ID: NCT01581658

Last Updated: 2017-08-14

Results Overview

change from baseline in total urinary glucose excretion (UGE) to 24 hours

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: baseline and 24 hours
• Results posted on: 2017-08-14

Participant Flow

Participant milestones

Measure	Normal Renal Function 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Overall Study STARTED	8	8	8	8
Overall Study COMPLETED	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Normal Renal Function n=8 Participants 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with severe renal impairment	Total n=32 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 3.1 • n=5 Participants	67.5 years STANDARD_DEVIATION 4.4 • n=7 Participants	65.9 years STANDARD_DEVIATION 5.5 • n=5 Participants	62.0 years STANDARD_DEVIATION 7.9 • n=4 Participants	65.5 years STANDARD_DEVIATION 5.6 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	23 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline and 24 hours

Population: Treated patients who had complete urine sample (baseline and 24 hours) for analyses.

change from baseline in total urinary glucose excretion (UGE) to 24 hours

Outcome measures

Measure	Normal Renal Function n=8 Participants 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment n=6 Participants 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment n=7 Participants 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Change From Baseline in Total Urinary Glucose Excretion (UGE)	74969.3 mg 95% Confidence Interval 4840.68 • Interval 64978.6 to 84960.0	62577.4 mg 95% Confidence Interval 5751.25 • Interval 50707.5 to 74447.4	57889.0 mg 95% Confidence Interval 4861.26 • Interval 47855.9 to 67922.2	23725.1 mg 95% Confidence Interval 5235.06 • Interval 12920.5 to 34529.7

PRIMARY outcome

Timeframe: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration

Population: Treated patients

Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity

Outcome measures

Measure	Normal Renal Function n=8 Participants 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Area Under the Concentration Time Curve of the Analyte in Plasma	7480 nmol*h/L Geometric Coefficient of Variation 16.2	9630 nmol*h/L Geometric Coefficient of Variation 15.9	10800 nmol*h/L Geometric Coefficient of Variation 9.55	11400 nmol*h/L Geometric Coefficient of Variation 40.4

PRIMARY outcome

Timeframe: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration

Population: Treated patients

Maximum concentration of the analyte in plasma

Outcome measures

Measure	Normal Renal Function n=8 Participants 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment n=8 Participants 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Maximum Concentration	1050 nmol/L Geometric Coefficient of Variation 19.1	984 nmol/L Geometric Coefficient of Variation 30.8	971 nmol/L Geometric Coefficient of Variation 26.2	990 nmol/L Geometric Coefficient of Variation 43.8

Adverse Events

Normal Renal Function

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Renal Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Renal Impairment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Severe Renal Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Normal Renal Function n=8 participants at risk 25 mg empagliflozin taken as a single dose for patients with normal renal function	Mild Renal Impairment n=8 participants at risk 25 mg empagliflozin taken as a single dose for patients with mild renal impairment	Moderate Renal Impairment n=8 participants at risk 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment	Severe Renal Impairment n=8 participants at risk 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	12.5% 1/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	12.5% 1/8 • From trial drug intake until the end-of-study examination visit, up to 12 days	0.00% 0/8 • From trial drug intake until the end-of-study examination visit, up to 12 days

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 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