parallel randomized trial

NCT00791479

Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

Type 2 diabetes (adults)NCT00791479S000376

Design

Randomized: 167
Start year: 2008
Treatment: 12 weeks, follow-up 16 weeks
Countries: United States, Mexico, Puerto Rico, Spain, Poland, Croatia, Russian Federation, India
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults with type 2 diabetes on no background glucose lowering drug

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: mixed model on pre rescue data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Dulaglutide 0.1 mg injection once weekly Dulaglutide 0.1 mg	none; lifestyle: not reported	35	34
A2	Dulaglutide 0.5 mg injection once weekly Dulaglutide 0.5 mg	none; lifestyle: not reported	34	30
A3	Dulaglutide 1.0 mg injection once weekly Dulaglutide 1.0 mg	none; lifestyle: not reported	34	32
A4	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	none; lifestyle: not reported	29	21
A5	Dulaglutide 3.0 mg subcutaneous once weekly Dulaglutide 3.0 mg	none; lifestyle: not reported	3
A6	Placebo Placebo	none; lifestyle: not reported	32	28

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide 0.1 mg injection once weekly A1	Dulaglutide 0.5 mg injection once weekly A2	Dulaglutide 1.0 mg injection once weekly A3	Dulaglutide 1.5 mg subcutaneous once weekly A4	Dulaglutide 3.0 mg subcutaneous once weekly A5	Placebo A6
age	mean (years)	56.33	56.91	57.16	57.45	60.82	55.03
age	sd (years)	9.15	9.06	8.76	7.88	7.15	9.33
asian	n	4	5	5	4	0	5
black	n	1	1	0	1	1	1
bmi	mean (kg/m2)	32.92	32.26	32.22	31.04	35.38	32.07
bmi	sd (kg/m2)	4.75	5.39	4.50	4.29	3.96	5.23
diabetes duration	mean (years)	3.90	3.72	3.28	4.62	5.00	3.91
diabetes duration	sd (years)	3.19	3.80	2.54	4.08	3.04	4.74
female	n	24	18	18	16	2	14
hba1c	mean (percent)	7.13	7.18	7.28	7.25	7.63	7.36
hba1c	sd (percent)	0.55	0.60	0.66	0.43	0.15	0.63
other american indian alaska native	n	1	0	2	0	0	0
other multiple race	n	0	0	0	0	0	1
other pacific islander	n	0	0	1	0	0	0
weight	mean (kg)	87.08	90.20	86.89	85.81	100.90	90.87
weight	sd (kg)	17.28	21.34	16.95	18.63	25.51	18.94
white	n	29	28	26	24	2	25

Analyses this trial contributes to

Results

81 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
12	A1	change	-0.37 percent	0.11	34	hypothetical; modified itt; registry:outcomes
12	A1 vs A6	md	-0.37 percent			hypothetical; modified itt; registry:outcomes
12	A2	change	-0.89 percent	0.12	30	hypothetical; modified itt; registry:outcomes
12	A2 vs A6	md	-0.89 percent			hypothetical; modified itt; registry:outcomes
12	A3	change	-1.03 percent	0.11	32	hypothetical; modified itt; registry:outcomes
12	A3 vs A6	md	-1.04 percent			hypothetical; modified itt; registry:outcomes
12	A4	change	-1.04 percent	0.13	21	hypothetical; modified itt; registry:outcomes
12	A4 vs A6	md	-1.04 percent			hypothetical; modified itt; registry:outcomes
12	A6	change	0.01 percent	0.13	28	hypothetical; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.19 kg	0.42	34	not stated; modified itt; registry:outcomes
12	A1 vs A6	md	1.19 kg			not stated; modified itt; registry:outcomes
12	A2	change	-0.34 kg	0.43	31	not stated; modified itt; registry:outcomes
12	A2 vs A6	md	1.04 kg			not stated; modified itt; registry:outcomes
12	A3	change	-1.11 kg	0.42	34	not stated; modified itt; registry:outcomes
12	A3 vs A6	md	0.27 kg			not stated; modified itt; registry:outcomes
12	A4	change	-1.49 kg	0.48	25	not stated; modified itt; registry:outcomes
12	A4 vs A6	md	-0.11 kg			not stated; modified itt; registry:outcomes
12	A6	change	-1.38 kg	0.45	30	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
12	A1	responders	47.1	34	hypothetical; modified itt; registry:outcomes
12	A2	responders	73.3	30	hypothetical; modified itt; registry:outcomes
12	A3	responders	75.0	32	hypothetical; modified itt; registry:outcomes
12	A4	responders	71.4	21	hypothetical; modified itt; registry:outcomes
12	A6	responders	21.4	28	hypothetical; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (5 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	hypothetical; modified itt; registry:outcomes
A2	events	0 / 34	hypothetical; modified itt; registry:outcomes
A3	events	0 / 34	hypothetical; modified itt; registry:outcomes
A4	events	0 / 29	hypothetical; modified itt; registry:outcomes
A6	events	0 / 32	hypothetical; modified itt; registry:outcomes

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-2.21 mmHg	2.04	34	not stated; modified itt; registry:outcomes
12	A2	change	0.51 mmHg	2.12	31	not stated; modified itt; registry:outcomes
12	A3	change	-2.57 mmHg	2.02	34	not stated; modified itt; registry:outcomes
12	A4	change	1.88 mmHg	2.33	25	not stated; modified itt; registry:outcomes
12	A6	change	-0.68 mmHg	2.18	30	not stated; modified itt; registry:outcomes

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; registry:adverse_events
A2	events	1 / 34	not stated; safety; registry:adverse_events
A3	events	1 / 34	not stated; safety; registry:adverse_events
A4	events	1 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 3	not stated; safety; registry:adverse_events
A6	events	1 / 32	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; randomized; registry:flow
A2	events	1 / 34	not stated; randomized; registry:flow
A3	events	0 / 34	not stated; randomized; registry:flow
A4	events	2 / 29	not stated; randomized; registry:flow
A5	events	0 / 3	not stated; randomized; registry:flow
A6	events	1 / 32	not stated; randomized; registry:flow

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 35	not stated; safety; registry:adverse_events
A2	events	0 / 34	not stated; safety; registry:adverse_events
A3	events	4 / 34	not stated; safety; registry:adverse_events
A4	events	2 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 3	not stated; safety; registry:adverse_events
A6	events	3 / 32	not stated; safety; registry:adverse_events

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 35	not stated; safety; registry:adverse_events
A2	events	0 / 34	not stated; safety; registry:adverse_events
A3	events	0 / 34	not stated; safety; registry:adverse_events
A4	events	2 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 3	not stated; safety; registry:adverse_events
A6	events	2 / 32	not stated; safety; registry:adverse_events

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 35	not stated; safety; registry:adverse_events
A2	events	3 / 34	not stated; safety; registry:adverse_events
A3	events	1 / 34	not stated; safety; registry:adverse_events
A4	events	3 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 3	not stated; safety; registry:adverse_events
A6	events	1 / 32	not stated; safety; registry:adverse_events

Constipation (6 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 35	not stated; safety; registry:adverse_events
A2	events	2 / 34	not stated; safety; registry:adverse_events
A3	events	1 / 34	not stated; safety; registry:adverse_events
A4	events	3 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 3	not stated; safety; registry:adverse_events
A6	events	1 / 32	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 34	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 34	not stated; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 29	not stated; safety; cholelithiasis; registry:adverse_events
A5	events	0 / 3	not stated; safety; cholelithiasis; registry:adverse_events
A6	events	1 / 32	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (6 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events
A2	events	0 / 34	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events
A3	events	0 / 34	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events
A4	events	0 / 29	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events
A5	events	0 / 3	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events
A6	events	1 / 32	not stated; safety; pancreatitis haemorrhagic; registry:adverse_events