parallel randomized trial

NCT00612794

Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00612794S000536

Design

Randomized: 30
Start year: 2007
Treatment: 10 weeks, follow-up 20 weeks
Countries: Japan (5 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: Japanese T2D age 20 to 75; weight 50 kg or more; HbA1c 6.5 to 10 percent; diet or oral drugs

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Placebo QW	diet and exercise or stable oral agents (SU, biguanide, TZD); lifestyle: not reported	10
A2	Exenatide extended release 0.8 mg injection once weekly Exenatide QW 0.8 mg	diet and exercise or stable oral agents (SU, biguanide, TZD); lifestyle: not reported	10
A3	Exenatide extended release 2 mg subcutaneous once weekly Exenatide QW 2.0 mg	diet and exercise or stable oral agents (SU, biguanide, TZD); lifestyle: not reported	9

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Exenatide extended release 0.8 mg injection once weekly A2	Exenatide extended release 2 mg subcutaneous once weekly A3
age	mean (years)	61	56	58
age	sd (years)	8	11	9
bmi	mean (kg/m2)	26.4	26.5	26.1
bmi	sd (kg/m2)	3.3	2.8	2.9
diabetes duration	mean (years)	7	6	5
diabetes duration	sd (years)	5	6	4
hba1c	mean (percent)	7.5	7.4	7.3
hba1c	sd (percent)	0.9	0.7	0.8
other biguanide agi	n	0	1	0
other biguanide agi	percent	0	10.0	0
other biguanide alone	n	1	1	0
other biguanide alone	percent	10.0	10.0	0
other diet exercise only	n	2	5	4
other diet exercise only	percent	20.0	50.0	44.4
other male	n	4	5	8
other male	percent	40.0	50.0	88.9
other su agi	n	0	0	1
other su agi	percent	0	0	11.1
other su alone	n	3	2	3
other su alone	percent	30.0	20.0	33.3
other su biguanide	n	2	0	0
other su biguanide	percent	20.0	0	0
other su tzd	n	1	1	1
other su tzd	percent	10.0	10.0	11.1
other tzd alone	n	1	0	0
other tzd alone	percent	10.0	0	0
weight	mean (kg)	68.2	69.1	71.9
weight	sd (kg)	14.2	15.1	11.4

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
10	A1	change	-0.4 percent	0.3	10	not stated; modified itt; R0027116:p6
10	A2	change	-1.0 percent	0.7	10	not stated; modified itt; R0027116:p6
10	A3	change	-1.5 percent	0.7	9	not stated; modified itt; R0027116:p6
20	A1	change	-0.07 percent	0.4	10	not stated; modified itt; R0027116:p6
20	A2	change	-0.6 percent	0.7	10	not stated; modified itt; R0027116:p6
20	A3	change	-0.7 percent	0.9	9	not stated; modified itt; R0027116:p6

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
10	A1	change	-1.6 kg	1.6	10	not stated; modified itt; R0027116:p9
10	A2	change	0.3 kg	2.2	10	not stated; modified itt; R0027116:p9
10	A3	change	-0.8 kg	1.5	9	not stated; modified itt; R0027116:p9
20	A1	change	-2.0 kg	1.9	10	not stated; modified itt; R0027116:p9
20	A2	change	-0.6 kg	2.9	10	not stated; modified itt; R0027116:p9
20	A3	change	-0.05 kg	1.3	9	not stated; modified itt; R0027116:p9

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Events / N	Detail
10	A1	responders	4 / 9	not stated; modified itt; hba1c:7.0_or_more; R0027116:p6
10	A2	responders	5 / 7	not stated; modified itt; hba1c:7.0_or_more; R0027116:p6
10	A3	responders	5 / 5	not stated; modified itt; hba1c:7.0_or_more; R0027116:p6

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; modified itt; R0027116:p5
A2	events	0 / 10	not stated; modified itt; R0027116:p5
A3	events	0 / 9	not stated; modified itt; R0027116:p5

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; modified itt; R0027116:p5
A2	events	0 / 10	not stated; modified itt; R0027116:p5
A3	events	0 / 9	not stated; modified itt; R0027116:p5

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				3 / 9	not stated; modified itt; R0027116:p5

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 10	not stated; modified itt; R0027116:p5
	A3	events				1 / 9	not stated; modified itt; R0027116:p5

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; modified itt; R0027116:p5
A2	events	0 / 10	not stated; modified itt; R0027116:p5
A3	events	0 / 9	not stated; modified itt; R0027116:p5