Trial Outcomes & Findings for Treatment of Diabetes in Patients With Systolic Heart Failure (NCT NCT02920918)

NCT ID: NCT02920918

Last Updated: 2019-10-29

Results Overview

Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2019-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Canagliflozin Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin
Overall Study STARTED	17	19
Overall Study COMPLETED	17	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Diabetes in Patients With Systolic Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Canagliflozin n=17 Participants Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin n=19 Participants Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	58.0 years STANDARD_DEVIATION 6.1 • n=5 Participants	54.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	56.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants
Peak Oxygen Consumption	16.2 mL/kg/min STANDARD_DEVIATION 3.4 • n=5 Participants	15.3 mL/kg/min STANDARD_DEVIATION 3.5 • n=7 Participants	15.7 mL/kg/min STANDARD_DEVIATION 3.4 • n=5 Participants
Ventilator Efficiency	34.1 Unitless STANDARD_DEVIATION 6.1 • n=5 Participants	32.6 Unitless STANDARD_DEVIATION 7.2 • n=7 Participants	33.3 Unitless STANDARD_DEVIATION 6.7 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Unadjusted p values were reported throughout, with statistical significance set at the 2-tailed 0.05 level. Only cases with available data used to compute the primary endpoint will be included in the analyses (16 subjects for canagliflozin group and 18 subjects for sitagliptin group).

Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test

Outcome measures

Outcome measures
Measure	Canagliflozin n=16 Participants Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin n=18 Participants Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin
Change From Baseline Aerobic Exercise Capacity at 12 Weeks	0.67 mL/kg/min Standard Deviation 2.10	-0.53 mL/kg/min Standard Deviation 1.75

PRIMARY outcome

Timeframe: baseline and 12 weeks

Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test

Outcome measures

Outcome measures
Measure	Canagliflozin n=16 Participants Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin n=18 Participants Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin
Change From Baseline Ventilatory Efficiency at 12 Weeks	-0.3 Unitless Standard Deviation 4.1	-0.3 Unitless Standard Deviation 5.1

Adverse Events

Canagliflozin

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Sitagliptin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Canagliflozin n=17 participants at risk Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin n=19 participants at risk Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin
Infections and infestations Influenza B	0.00% 0/17 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	5.3% 1/19 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Vascular disorders Occlusion superficial femoral artery	5.9% 1/17 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	0.00% 0/19 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Cardiac disorders Heart failure	5.9% 1/17 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	0.00% 0/19 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Renal and urinary disorders Dizziness and acute kidney injury	5.9% 1/17 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	0.00% 0/19 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.

Other adverse events

Other adverse events
Measure	Canagliflozin n=17 participants at risk Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks. Canagliflozin	Sitagliptin n=19 participants at risk Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks. Sitagliptin
Infections and infestations Genital infection	5.9% 1/17 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	5.3% 1/19 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Cardiac disorders Hypotensive event	11.8% 2/17 • Number of events 2 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	5.3% 1/19 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Cardiac disorders Arrhythmic events	5.9% 1/17 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	5.3% 1/19 • Number of events 1 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.
Renal and urinary disorders Acute kidney injury	17.6% 3/17 • Number of events 3 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.	15.8% 3/19 • Number of events 3 • 12 weeks An Adverse Event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An event that is considered by the investigator(s) to be expected and related to the natural history of the disease is not considered an AE.

Additional Information

Salvatore Carbone

Virginia Commonwealth University

Phone: 804 628 3980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place