parallel randomized trial

LIRAVIS

Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in a Sub Saharan African Population With Type 2 Diabetes

Type 2 diabetes (adults)NCT02832999S000773

Design

Randomized: 14
Start year: 2015
Treatment: 2 weeks, follow-up 2 weeks
Countries: Cameroon (1 sites)
Sponsor: Yaounde Central Hospital (not reported)
Eligibility: adults with type 2 diabetes on one or two oral drugs; HbA1c 7 percent or more; eGFR 30 or more; incretin naive

Conduct and analysis

Blinding: single blind
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	metformin alone or with sulfonylurea; lifestyle: not reported	7	7
A2	Vildagliptin Vildagliptin 100 mg/day	metformin alone or with sulfonylurea; lifestyle: not reported	7	7

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Vildagliptin A2	Whole trial ALL
age	median (years)	57	51
age	q1 (years)	41	49
age	q3 (years)	61	63
bmi	median (kg/m2)	29.6	30.3
bmi	q1 (kg/m2)	28.5	23.1
bmi	q3 (kg/m2)	35.8	32.7
diabetes duration: 10 or more years	n	1	4
diabetes duration: 10 or more years	percent	14.3	57.1
diabetes duration: lt 10 years	n	6	3
diabetes duration: lt 10 years	percent	85.7	42.9
female	n	4	6
female	percent	57.1	85.7
hba1c	median (mmol/mol)			76
hba1c	q1 (mmol/mol)			67
hba1c	q3 (mmol/mol)			97
other background therapy: biguanide only	n	5	4
other background therapy: biguanide only	percent	71.4	57.1
other background therapy: biguanide sulfonylurea	n	2	3
other background therapy: biguanide sulfonylurea	percent	28.6	42.9
sbp	median (mmHg)	131	131
sbp	q1 (mmHg)	121	120
sbp	q3 (mmHg)	139	143
waist	median (cm)	103	95
waist	q1 (cm)	94	81
waist	q3 (cm)	109	98
weight	median (kg)	91.7	77.5
weight	q1 (kg)	81.6	66.1
weight	q3 (kg)	100	92.4

Analyses this trial contributes to

Results

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

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	Events / N	Detail
2	A1	change	-0.6 kg	7	not stated; randomized; R0055449:Results
2	A1	final	kg	7	not stated; randomized; R0055449:Table 2
2	A2	change	1.1 kg	7	not stated; randomized; R0055449:Results
2	A2	final	kg	7	not stated; randomized; R0055449:Table 2

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	Events / N	Detail
2	A1	final	mmHg	7	not stated; randomized; R0055449:Table 2
2	A1	final	mmHg	7	not stated; randomized; R0055449:Table 2
2	A2	final	mmHg	7	not stated; randomized; R0055449:Table 2
2	A2	final	mmHg	7	not stated; randomized; R0055449:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0055449:Figure 1
	A2	events				0 / 7	not stated; randomized; R0055449:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 7	not stated; randomized; R0055449:Table 5
	A2	events				3 / 7	not stated; randomized; R0055449:Table 5

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 7	not stated; randomized; R0055449:Table 5
	A2	events				1 / 7	not stated; randomized; R0055449:Table 5