parallel randomized trial

S003071

Type 2 diabetes (adults)S003071

Design

Randomized: 99
Start year: 2010
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (21 sites)
Sponsor: (non industry)
Eligibility: age 18 to under 80; HbA1c 6.9 to 9.4 percent NGSP; BMI 35 or less; on sulfonylurea

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: per protocol
Missing data: no imputation, available data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg	sulfonylurea; lifestyle: none	50	44
A2	Sitagliptin Sitagliptin 50 to 100 mg	sulfonylurea; lifestyle: none	49	38

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 0.9 mg injection once daily A1	Sitagliptin A2
age	mean (years)	61.1	61.5
age	sd (years)	8.6	9.7
bmi	mean (kg/m2)	26.00	25.75
bmi	sd (kg/m2)	3.33	3.42
diabetes duration	mean (years)	11.68	10.99
diabetes duration	sd (years)	7.20	6.69
female	n	17	17
female	percent	34.0	34.7
hba1c	mean (percent)	7.69	7.92
hba1c	sd (percent)	0.89	1.02
weight	mean (kg)	69.35	67.86
weight	sd (kg)	12.68	12.52

Analyses this trial contributes to

Results

37 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	Detail
20	A1	change	-0.65 percent	0.89	not stated; other; R0023696:Table 2
20	A2	change	-0.27 percent	0.90	not stated; other; R0023696:Table 2
24	A1	change	-0.59 percent	0.80	not stated; other; R0023696:Table 2
24	A1	change	-0.63 percent	0.85	not stated; per protocol; R0023696:Results
24	A2	change	-0.24 percent	0.94	not stated; other; R0023696:Table 2
24	A2	change	-0.19 percent	0.85	not stated; per protocol; R0023696:Results

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-0.60 kg	2.44		36	not stated; other; R0023696:Table 3
24	A2	change	0.29 kg	2.05		38	not stated; other; R0023696:Table 3

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Events / N	Detail
20	A1	responders	18 / 44	not stated; other; R0023696:Table 2
20	A2	responders	12 / 40	not stated; other; R0023696:Table 2
24	A1	responders	15 / 38	not stated; other; R0023696:Table 2
24	A2	responders	10 / 38	not stated; other; R0023696:Table 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	9 / 50	not stated; randomized; R0023696:Results
A1	events	0 / 50	not stated; randomized; R0023696:Results
A2	events	0 / 49	not stated; randomized; R0023696:Results
A2	events	5 / 49	not stated; randomized; R0023696:Results

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 50	not stated; randomized; R0023696:Results
	A2	events				1 / 49	not stated; randomized; R0023696:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 50	not stated; randomized; R0023696:Results
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 50	not stated; randomized; R0023696:Results
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Diabetic retinopathy complications (1 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 49	not stated; randomized; R0023696:Results