parallel randomized trial

NCT00943917

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00943917S001812

Design

Randomized: 155
Start year: 2009
Treatment: 24 weeks, follow-up 28 weeks
Countries: United States (50 sites)
Sponsor: Intarcia Therapeutics (industry)
Eligibility: age 18 to 70; HbA1c 7 to 10 percent; BMI 40 or less; stable metformin 3 months

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide (ITCA 650 implant) 20 ug implant continuous ITCA 650 20 ug/day	metformin; lifestyle: not reported	51	51	47
A2	Exenatide (ITCA 650 implant) 40 µg implant continuous ITCA 650 40 ug/day	metformin; lifestyle: not reported	51	51	48
A3	Exenatide 10 ug subcutaneous twice daily Exenatide twice daily	metformin; lifestyle: not reported	53	52	47

Baseline characteristics

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

Characteristic	Statistic	Exenatide (ITCA 650 implant) 20 ug implant continuous A1	Exenatide (ITCA 650 implant) 40 µg implant continuous A2	Exenatide 10 ug subcutaneous twice daily A3
age: 18 to 60	n	41	37	39
age: 60 or more	n	10	14	14
age	mean (years)	54.0	53.3	53.8
age	sd (years)	8.3	8.9	9.6
black	n	3	10	5
black	percent	5.9	19.6	9.4
bmi	mean (kg/m2)	33.5	31.8	33.0
bmi	sd (kg/m2)	4.5	4.9	4.4
diabetes duration	mean (years)	6.2	8.4	5.2
diabetes duration	sd (years)	5.2	10.2	3.5
female	n	26	28	24
hba1c	mean (percent)	7.85	7.95	8.00
hba1c	sd (percent)	0.79	0.82	0.92
hispanic	n	23	16	19
hispanic	percent	45.1	31.4	35.8
other race other	n	1	1	0
other race other	percent	2.0	2.0
weight	mean (kg)	93.5	91.5	93.4
weight	sd (kg)	15.8	18.3	15.6
white	n	47	40	48
white	percent	92.1	78.4	90.6

Analyses this trial contributes to

Results

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

HbA1c change (27 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-.93 percent	0.882	51	not stated; modified itt; registry:outcomes
12	A1	change	-0.98 percent	0.096	51	not stated; other; R0019710:Table 2
12	A1	change	-0.96 percent	0.905	47	not stated; per protocol; registry:outcomes
12	A2	change	-0.95 percent	0.095	51	not stated; other; R0019710:Table 2
12	A2	change	-0.96 percent	0.724	51	not stated; modified itt; registry:outcomes
12	A2	change	-1.04 percent	0.713	45	not stated; per protocol; registry:outcomes
12	A3	change	-0.72 percent	0.095	52	not stated; other; R0019710:Table 2
12	A3	change	-0.75 percent	0.866	52	not stated; modified itt; registry:outcomes
12	A3	change	-0.82 percent	0.870	47	not stated; per protocol; registry:outcomes
24	A1	change	-0.89 percent	0.17	22	not stated; other; group:20_20; R0019710:Table 2
24	A1	change	-0.89 percent	0.660	22	not stated; modified itt; group:20_20; registry:outcomes
24	A1	change	-.89 percent	.660	20	not stated; per protocol; group:20_20; registry:outcomes
24	A1	change	-1.36 percent	0.17	21	not stated; other; group:20_60; R0019710:Table 2
24	A1	change	-1.26 percent	0.950	21	not stated; modified itt; group:20_60; registry:outcomes
24	A1	change	-1.26 percent	.950	21	not stated; per protocol; group:20_60; registry:outcomes
24	A2	change	-0.75 percent	0.16	23	not stated; other; group:40_40; R0019710:Table 2
24	A2	change	-0.70 percent	0.892	23	not stated; modified itt; group:40_40; registry:outcomes
24	A2	change	-0.67 percent	.908	19	not stated; per protocol; group:40_40; registry:outcomes
24	A2	change	-1.40 percent	0.16	24	not stated; other; group:40_80; R0019710:Table 2
24	A2	change	-1.36 percent	0.664	23	not stated; modified itt; group:40_80; registry:outcomes
24	A2	change	-1.36 percent	0.664	19	not stated; per protocol; group:40_80; registry:outcomes
24	A3	change	-1.13 percent	0.16	23	not stated; other; group:exbid_40; R0019710:Table 2
24	A3	change	-1.01 percent	0.823	22	not stated; modified itt; group:exbid_40; registry:outcomes
24	A3	change	-1.01 percent	0.823	22	not stated; per protocol; group:exbid_40; registry:outcomes
24	A3	change	-1.17 percent	0.17	22	not stated; other; group:exbid_60; R0019710:Table 2
24	A3	change	-1.51 percent	1.266	22	not stated; modified itt; group:exbid_60; registry:outcomes
24	A3	change	-1.51 percent	1.266	20	not stated; per protocol; group:exbid_60; registry:outcomes

Body weight change in kilograms (diabetes) (9 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.9 kg	0.4	51	not stated; other; R0019710:Table 2
12	A2	change	-2.0 kg	0.4	51	not stated; other; R0019710:Table 2
12	A3	change	-1.2 kg	0.4	52	not stated; other; R0019710:Table 2
24	A1	change	-0.8 kg	0.8	22	not stated; other; group:20_20; R0019710:Table 2
24	A1	change	-3.1 kg	0.3	21	not stated; other; group:20_60; R0019710:Table 2
24	A2	change	-3.7 kg	0.8	23	not stated; other; group:40_40; R0019710:Table 2
24	A2	change	-3.2 kg	0.8	24	not stated; other; group:40_80; R0019710:Table 2
24	A3	change	-3.7 kg	0.8	23	not stated; other; group:exbid_40; R0019710:Table 2
24	A3	change	-2.8 kg	0.8	22	not stated; other; group:exbid_60; R0019710:Table 2

HbA1c below 7 percent (7 lines; O03)

Week	Arm	Statistic	Estimate	Detail
12	A1	responders	63	not stated; other; R0019710:Results
12	A2	responders	65	not stated; other; R0019710:Results
12	A3	responders	50.0	not stated; other; R0019710:Results
24	A1	responders	86	not stated; other; group:20_60; R0019710:Results
24	A1	responders	60	not stated; other; group:20_20; R0019710:Results
24	A2	responders	65	not stated; other; group:40_40; R0019710:Results
24	A2	responders	78	not stated; other; group:40_80; R0019710:Results

Serious adverse events (9 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	not stated; safety; registry:adverse_events
A1	events	1 / 20	not stated; safety; group:20_20; registry:adverse_events
A1	events	1 / 21	not stated; safety; group:20_60; registry:adverse_events
A2	events	2 / 23	not stated; safety; group:40_80; registry:adverse_events
A2	events	0 / 51	not stated; safety; registry:adverse_events
A2	events	2 / 23	not stated; safety; group:40_40; registry:adverse_events
A3	events	0 / 21	not stated; safety; group:exbid_60; registry:adverse_events
A3	events	0 / 23	not stated; safety; group:exbid_40; registry:adverse_events
A3	events	0 / 53	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (18 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 21	not stated; randomized; group:20_60; registry:flow
A1	events	2 / 51	not stated; safety; R0019710:Table 3
A1	events	0 / 20	not stated; safety; group:20_20; R0019710:Table 3
A1	events	1 / 51	not stated; randomized; registry:flow
A1	events	0 / 20	not stated; randomized; group:20_20; registry:flow
A1	events	0 / 21	not stated; safety; group:20_60; R0019710:Table 3
A2	events	1 / 23	not stated; randomized; group:40_40; registry:flow
A2	events	2 / 51	not stated; safety; R0019710:Table 3
A2	events	2 / 51	not stated; randomized; registry:flow
A2	events	1 / 23	not stated; safety; group:40_80; R0019710:Table 3
A2	events	3 / 23	not stated; randomized; group:40_80; registry:flow
A2	events	1 / 23	not stated; safety; group:40_40; R0019710:Table 3
A3	events	2 / 53	not stated; randomized; registry:flow
A3	events	3 / 53	not stated; safety; R0019710:Table 3
A3	events	1 / 23	not stated; safety; group:exbid_40; R0019710:Table 3
A3	events	0 / 23	not stated; randomized; group:exbid_40; registry:flow
A3	events	1 / 21	not stated; safety; group:exbid_60; R0019710:Table 3
A3	events	1 / 21	not stated; randomized; group:exbid_60; registry:flow

Nausea (9 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 20	not stated; safety; group:20_20; registry:adverse_events
A1	events	17 / 51	not stated; safety; registry:adverse_events
A1	events	7 / 21	not stated; safety; group:20_60; registry:adverse_events
A2	events	24 / 51	not stated; safety; registry:adverse_events
A2	events	1 / 23	not stated; safety; group:40_40; registry:adverse_events
A2	events	6 / 23	not stated; safety; group:40_80; registry:adverse_events
A3	events	8 / 21	not stated; safety; group:exbid_60; registry:adverse_events
A3	events	19 / 53	not stated; safety; registry:adverse_events
A3	events	1 / 23	not stated; safety; group:exbid_40; registry:adverse_events

Vomiting (9 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	6 / 51	not stated; safety; registry:adverse_events
A1	events	1 / 20	not stated; safety; group:20_20; registry:adverse_events
A1	events	0 / 21	not stated; safety; group:20_60; registry:adverse_events
A2	events	1 / 23	not stated; safety; group:40_40; registry:adverse_events
A2	events	5 / 23	not stated; safety; group:40_80; registry:adverse_events
A2	events	9 / 51	not stated; safety; registry:adverse_events
A3	events	1 / 23	not stated; safety; group:exbid_40; registry:adverse_events
A3	events	5 / 21	not stated; safety; group:exbid_60; registry:adverse_events
A3	events	4 / 53	not stated; safety; registry:adverse_events

Diarrhea (9 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 21	not stated; safety; group:20_60; registry:adverse_events
A1	events	2 / 51	not stated; safety; registry:adverse_events
A1	events	1 / 20	not stated; safety; group:20_20; registry:adverse_events
A2	events	3 / 23	not stated; safety; group:40_80; registry:adverse_events
A2	events	8 / 51	not stated; safety; registry:adverse_events
A2	events	1 / 23	not stated; safety; group:40_40; registry:adverse_events
A3	events	3 / 53	not stated; safety; registry:adverse_events
A3	events	4 / 23	not stated; safety; group:exbid_40; registry:adverse_events
A3	events	4 / 21	not stated; safety; group:exbid_60; registry:adverse_events

Constipation (9 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	3 / 51	not stated; safety; registry:adverse_events
A1	events	0 / 21	not stated; safety; group:20_60; registry:adverse_events
A1	events	0 / 20	not stated; safety; group:20_20; registry:adverse_events
A2	events	0 / 23	not stated; safety; group:40_80; registry:adverse_events
A2	events	4 / 51	not stated; safety; registry:adverse_events
A2	events	2 / 23	not stated; safety; group:40_40; registry:adverse_events
A3	events	3 / 23	not stated; safety; group:exbid_40; registry:adverse_events
A3	events	1 / 53	not stated; safety; registry:adverse_events
A3	events	4 / 21	not stated; safety; group:exbid_60; registry:adverse_events

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 20	not stated; safety; group:20_20; cholecyctitis acute; registry:adverse_events
A1	events	1 / 51	not stated; safety; cholecyctitis acute; registry:adverse_events
A1	events	0 / 21	not stated; safety; group:20_60; cholecyctitis acute; registry:adverse_events
A2	events	0 / 51	not stated; safety; cholecyctitis acute; registry:adverse_events
A2	events	0 / 19	not stated; safety; group:40_40; cholecyctitis acute; registry:adverse_events
A2	events	0 / 19	not stated; safety; group:40_80; cholecyctitis acute; registry:adverse_events
A3	events	0 / 20	not stated; safety; group:exbid_60; cholecyctitis acute; registry:adverse_events
A3	events	0 / 22	not stated; safety; group:exbid_40; cholecyctitis acute; registry:adverse_events
A3	events	0 / 53	not stated; safety; cholecyctitis acute; registry:adverse_events