Trial Outcomes & Findings for Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration (NCT NCT01392560)

Last Updated: 2014-06-17

Results Overview

The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2014-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Empagliflozin (BI 10773) 25 mg Oral once daily Empagliflozin 25 mg: Oral once daily
Overall Study STARTED	52
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Empagliflozin (BI 10773) 25 mg Oral once daily Empagliflozin 25 mg: Oral once daily
Overall Study Adverse Event	2
Overall Study not entered	8
Overall Study discontinued during placebo run-in	2

Baseline Characteristics

Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empagliflozin (BI 10773) 25 mg n=42 Participants Oral once daily Empagliflozin 25 mg: Oral once daily
Age, Continuous	24.1 years STANDARD_DEVIATION 5.0 • n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	20 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Per protocol set for renal (PPS\_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.

The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia

Outcome measures

Outcome measures
Measure	All Patients (Empagliflozin 25 mg) n=40 Participants All patients (hyperfilterers and non-hyperfilterers) Empagliflozin 25 mg: Oral once daily	Hyperfilterers (Empagliflozin 25 mg) n=27 Participants Hyperfilterers Empagliflozin 25 mg: Oral once daily hyperfilterers = GFRs of ≥135 mL/min/1.73m2	Non-hyperfilterers (Empagliflozin 25 mg) n=13 Participants Non-hyperfilterers Empagliflozin 25 mg: Oral once daily non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to \<135 mL/min/1.73m2
Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia Euglycaemia	-19.6 mL/min/1.73 m^2 Standard Error 5.6	-33.4 mL/min/1.73 m^2 Standard Error 6.2	9.0 mL/min/1.73 m^2 Standard Error 5.9
Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia Hyperglycaemia	-30.8 mL/min/1.73 m^2 Standard Error 6.2	-44.5 mL/min/1.73 m^2 Standard Error 7.1	-2.4 mL/min/1.73 m^2 Standard Error 7.7

Adverse Events

Empagliflozin 25 mg

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Empagliflozin 25 mg n=42 participants at risk Oral once daily Empagliflozin 25 mg: Oral once daily
Infections and infestations Gastroenteritis viral	2.4% 1/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Metabolism and nutrition disorders Diabetic ketoacidosis	4.8% 2/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.

Other adverse events

Other adverse events
Measure	Empagliflozin 25 mg n=42 participants at risk Oral once daily Empagliflozin 25 mg: Oral once daily
Gastrointestinal disorders Abdominal pain	11.9% 5/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Gastrointestinal disorders Dry mouth	16.7% 7/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Gastrointestinal disorders Nausea	16.7% 7/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Gastrointestinal disorders Vomiting	14.3% 6/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
General disorders Thirst	73.8% 31/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Infections and infestations Genitourinary tract infection	14.3% 6/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Infections and infestations Influenza	9.5% 4/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Infections and infestations Nasopharyngitis	26.2% 11/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Metabolism and nutrition disorders Hypoglycaemia	95.2% 40/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Musculoskeletal and connective tissue disorders Back pain	9.5% 4/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Nervous system disorders Dizziness	14.3% 6/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Nervous system disorders Headache	23.8% 10/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Renal and urinary disorders Pollakiuria	78.6% 33/42 • 8 weeks All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.

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