parallel randomized trial

NCT00577824

Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Design

Randomized: 181
Start year: 2008
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (23 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 20 to 75; HbA1c 7.0 to 10.0 percent JDS; weight 50 kg or more; sulfonylurea based oral therapy

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: not reported	36	35
A2	Exenatide 5 ug subcutaneous twice daily Exenatide 5 μg BID	sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: not reported	72	72
A3	Exenatide 10 ug subcutaneous twice daily Exenatide 10 μg BID	sulfonylurea alone or with biguanide or thiazolidinedione; lifestyle: not reported	73	72

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

Characteristic	Statistic	Placebo A1	Exenatide 5 ug subcutaneous twice daily A2	Exenatide 10 ug subcutaneous twice daily A3
age: 18 or less	n	0	0	0
age: 18 to 65	n	27	53	46
age: 65 or older	n	8	19	26
age	mean (years)	56.3	58.5	59.4
age	sd (years)	11.4	9.3	9.8
bmi	mean (kg/m2)	25.8	25.0	25.8
bmi	sd (kg/m2)	4.2	4.1	3.9
diabetes duration	mean (years)	12.4	12.2	11.6
diabetes duration	sd (years)	6.5	6.3	7.0
female	n	11	23	23
hba1c	mean (percent JDS)	8.1	8.3	8.2
hba1c	sd (percent JDS)	0.9	0.8	1.0
weight	mean (kg)	70.3	67.0	69.1
weight	sd (kg)	13.3	11.5	11.2

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
20	A1	change	-0.2 percent JDS			not stated; full analysis; R0018881:Figure 2
20	A2	change	-1.5 percent JDS			not stated; full analysis; R0018881:Figure 2
20	A3	change	-1.8 percent JDS			not stated; full analysis; R0018881:Figure 2
24	A1	change	-0.28 percent JDS	0.15	35	not stated; full analysis; R0018881:Results
24	A1	change	-0.2 percent JDS			not stated; full analysis; R0018881:Figure 2
24	A2	change	-1.34 percent JDS	0.11	71	not stated; full analysis; R0018881:Results
24	A2	change	-1.5 percent JDS			not stated; full analysis; R0018881:Figure 2
24	A3	change	-1.62 percent JDS	0.11	72	not stated; full analysis; R0018881:Results
24	A3	change	-1.9 percent JDS			not stated; full analysis; R0018881:Figure 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-0.47 kg	0.39	35	not stated; full analysis; R0018881:Results
24	A2	change	-0.39 kg	0.28	71	not stated; full analysis; R0018881:Results
24	A3	change	-1.54 kg	0.27	72	not stated; full analysis; R0018881:Results

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	15.2	5 / 33	not stated; full analysis; R0018881:Results
24	A2	responders	67.1	47 / 70	not stated; full analysis; R0018881:Results
24	A3	responders	71.0	49 / 69	not stated; full analysis; R0018881:Results

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	8 / 35	not stated; full analysis; R0018881:Table 2
A1	events	4 / 35	not stated; full analysis; R0018881:Table 2
A1	events	0 / 35	not stated; full analysis; R0018881:Results
A2	events	37 / 72	not stated; full analysis; R0018881:Table 2
A2	events	0 / 72	not stated; full analysis; R0018881:Results
A2	events	10 / 72	not stated; full analysis; R0018881:Table 2
A3	events	42 / 72	not stated; full analysis; R0018881:Table 2
A3	events	18 / 72	not stated; full analysis; R0018881:Table 2
A3	events	0 / 72	not stated; full analysis; R0018881:Results

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; full analysis; R0018881:Results
A2	events	0 / 72	not stated; full analysis; R0018881:Results
A3	events	0 / 72	not stated; full analysis; R0018881:Results

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				0 / 72	not stated; full analysis; R0018881:Results

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	4 / 35	not stated; full analysis; R0018881:Results
A2	events	2 / 72	not stated; full analysis; R0018881:Results
A3	events	0 / 72	not stated; full analysis; R0018881:Results

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 36	not stated; randomized; R0018881:Figure 1
A1	events	0 / 35	not stated; full analysis; R0018881:Results
A2	events	6 / 72	not stated; randomized; R0018881:Figure 1
A2	events	4 / 72	not stated; full analysis; R0018881:Results
A3	events	18 / 73	not stated; randomized; R0018881:Figure 1
A3	events	18 / 72	not stated; full analysis; R0018881:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 35	not stated; full analysis; R0018881:Table 2
A2	events	18 / 72	not stated; full analysis; R0018881:Table 2
A3	events	26 / 72	not stated; full analysis; R0018881:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 35	not stated; full analysis; R0018881:Table 2
A2	events	3 / 72	not stated; full analysis; R0018881:Table 2
A3	events	12 / 72	not stated; full analysis; R0018881:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 35	not stated; full analysis; R0018881:Table 2
A2	events	8 / 72	not stated; full analysis; R0018881:Table 2
A3	events	4 / 72	not stated; full analysis; R0018881:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 35	not stated; full analysis; R0018881:Table 2
A2	events	10 / 72	not stated; full analysis; R0018881:Table 2
A3	events	11 / 72	not stated; full analysis; R0018881:Table 2

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; full analysis; R0018881:Results
A2	events	0 / 72	not stated; full analysis; R0018881:Results
A3	events	0 / 72	not stated; full analysis; R0018881:Results