parallel randomized trial

NCT01149421

The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT01149421S000784

Design

Randomized: 755
Start year: 2010
Treatment: 26 weeks
Countries: United States, Czech Republic, Puerto Rico, Canada, Argentina, Brazil, Denmark, India
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults 18 or older; HbA1c 7 to 9.5 percent; stable oral agents

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	stable oral antihyperglycemic medication; lifestyle: not reported	251	247
A2	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg	stable oral antihyperglycemic medication; lifestyle: not reported	254	251
A3	Placebo Placebo	stable oral glucose lowering drugs; lifestyle: not reported	250	249

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide 1.5 mg subcutaneous once weekly A1	Dulaglutide 0.75 mg subcutaneous once weekly A2	Placebo A3	Whole trial ALL
age	mean (years)	55.96	57.05	56.43
age	sd (years)	10.14	10.17	10.50
asian	n	22	24	23
black	n	23	21	22
bmi	mean (kg/m2)	32.80	32.55	33.53
bmi	sd (kg/m2)	5.66	5.86	6.49
diabetes duration	mean (years)	7.61	8.99	8.40
diabetes duration	sd (years)	5.30	6.39	5.76
egfr: <60	n				51
egfr: <60	percent				6.8
female	n	121	123	119
hba1c	mean (percent)	7.93	7.91	7.94
hba1c	sd (percent)	0.76	0.73	0.78
hispanic	n	95	101	91
other race american indian alaska native	n	2	0	0
other race multiple	n	3	5	1
other race native hawaiian pacific islander	n	0	0	1
sbp	mean (mmHg)	130.85	132.08	131.13
sbp	sd (mmHg)	12.14	12.97	11.23
uacr: >300	n				24
uacr: >300	percent				3.2
weight	mean (kg)	90.42	90.45	93.90
weight	sd (kg)	18.58	18.74	21.26
white	n	201	204	203

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-1.01 percent	0.07	251	not stated; modified itt; registry:outcomes
26	A2	change	-0.89 percent	0.06	254	not stated; modified itt; registry:outcomes
26	A3	change	-0.02 percent	0.06	250	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-1.85 kg	0.23	251	not stated; modified itt; registry:outcomes
26	A2	change	-0.86 kg	0.22	254	not stated; modified itt; registry:outcomes
26	A3	change	-0.08 kg	0.22	250	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	62.1	206	not stated; modified itt; registry:outcomes
26	A2	responders	54.9	226	not stated; modified itt; registry:outcomes
26	A3	responders	14.3	210	not stated; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 251	not stated; safety; registry:outcomes
A2	events	0 / 254	not stated; safety; registry:outcomes
A3	events	0 / 250	not stated; safety; registry:outcomes

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.51 mmHg	0.63		247	not stated; modified itt; registry:outcomes
26	A1	change	-2.29 mmHg	0.77		251	not stated; modified itt; registry:outcomes
26	A1 vs A3	md	-2.66 mmHg		-4.53 to -0.79		not stated; modified itt; registry:outcomes
26	A2	change	-1.56 mmHg	0.60		251	not stated; modified itt; registry:outcomes
26	A2	change	-0.74 mmHg	0.74		254	not stated; modified itt; registry:outcomes
26	A2 vs A3	md	-1.71 mmHg		-3.54 to 0.12		not stated; modified itt; registry:outcomes
26	A3	change	0.15 mmHg	0.62		249	not stated; modified itt; registry:outcomes
26	A3	change	0.40 mmHg	0.75		250	not stated; modified itt; registry:outcomes

Acute kidney injury (3 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 251	not stated; safety; renal failure acute; registry:adverse_events
A2	events	0 / 254	not stated; safety; renal failure acute; registry:adverse_events
A3	events	1 / 250	not stated; safety; renal failure acute; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	12 / 251	not stated; safety; registry:adverse_events
A2	events	8 / 254	not stated; safety; registry:adverse_events
A3	events	8 / 250	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	22 / 251	not stated; randomized; registry:flow
A2	events	6 / 254	not stated; randomized; registry:flow
A3	events	11 / 250	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	35 / 251	not stated; safety; registry:adverse_events
A2	events	18 / 254	not stated; safety; registry:adverse_events
A3	events	16 / 250	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	19 / 251	not stated; safety; registry:adverse_events
A2	events	11 / 254	not stated; safety; registry:adverse_events
A3	events	11 / 250	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	31 / 251	not stated; safety; registry:adverse_events
A2	events	24 / 254	not stated; safety; registry:adverse_events
A3	events	20 / 250	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	8 / 251	not stated; safety; registry:adverse_events
A2	events	12 / 254	not stated; safety; registry:adverse_events
A3	events	2 / 250	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (3 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	2 / 251	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 254	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 250	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 251	not stated; safety; registry:outcomes
A2	events	0 / 254	not stated; safety; registry:outcomes
A3	events	0 / 250	not stated; safety; registry:outcomes

Any cancer (3 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 251	not stated; safety; malignant melanoma; registry:adverse_events
A2	events	0 / 254	not stated; safety; malignant melanoma; registry:adverse_events
A3	events	1 / 250	not stated; safety; malignant melanoma; registry:adverse_events