parallel randomized trial

NCT02324842

Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients

Type 2 diabetes (adults)NCT02324842S001422

Design

Randomized: 45
Start year: 2014
Treatment: 16 weeks, follow-up 16 weeks
Countries: United States (1 sites)
Sponsor: The University of Texas Health Science Center at San Antonio (industry)
Eligibility: T2DM, HbA1c 7 to 11 percent, eGFR 60 or more, drug naive or metformin with or without SU

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Canagliflozin Canagliflozin (CANA)	drug naive or stable metformin with or without sulfonylurea; lifestyle: not reported	15	15
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide (LIRA)	drug naive or stable metformin with or without sulfonylurea; lifestyle: not reported	15	15
A3	Liraglutide plus canagliflozin 1.8 to 300 mg injection once daily Canagliflozin plus liraglutide (CANA/LIRA)	drug naive or stable metformin with or without sulfonylurea; lifestyle: not reported	15	15

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Canagliflozin A1	Liraglutide 1.8 mg subcutaneous once daily A2	Liraglutide plus canagliflozin 1.8 to 300 mg injection once daily A3	Whole trial ALL
age: 18 or less	n	0	0	0
age: 18 to 65	n	14	14	13
age: 65 or more	n	0	0	0
female	n	4	6	7
hba1c	mean (percent)				8.2
metformin use	n				39
other drug naive	n				6

Analyses this trial contributes to

Results

27 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-0.89 percent	0.24	15	not stated; randomized; R0024524:Results
16	A2	change	-1.44 percent	0.39	15	not stated; randomized; R0024524:Results
16	A3	change	-1.67 percent	0.29	15	not stated; randomized; R0024524:Results
17.38	A1	final	8.2 percent	0.3	15	not stated; randomized; registry:outcomes
17.38	A2	final	8.4 percent	0.3	15	not stated; randomized; registry:outcomes
17.38	A3	final	8.1 percent	0.3	15	not stated; randomized; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-3.5 kg	0.5	15	not stated; randomized; R0024524:Results
16	A2	change	-1.9 kg	0.8	15	not stated; randomized; R0024524:Results
16	A3	change	-6.0 kg	0.8	15	not stated; randomized; R0024524:Results

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; registry:adverse_events
A2	events	3 / 15	not stated; safety; registry:adverse_events
A3	events	3 / 15	not stated; safety; registry:adverse_events

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-5.2 mmHg	2.2	15	not stated; randomized; R0024524:Results
16	A2	change	5.1 mmHg	3.8	15	not stated; randomized; R0024524:Results
16	A3	change	-14.1 mmHg	3.0	15	not stated; randomized; R0024524:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; registry:adverse_events
A2	events	0 / 15	not stated; safety; registry:adverse_events
A3	events	0 / 15	not stated; safety; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 15	not stated; safety; registry:adverse_events
A2	events	0 / 15	not stated; safety; registry:adverse_events
A3	events	0 / 15	not stated; safety; registry:adverse_events

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 15	not stated; safety; registry:adverse_events
A2	events	9 / 15	not stated; safety; registry:adverse_events
A3	events	8 / 15	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; safety; registry:adverse_events
A2	events	5 / 15	not stated; safety; registry:adverse_events
A3	events	5 / 15	not stated; safety; registry:adverse_events