parallel randomized trial

S003088

Type 2 diabetes (adults)S003088

Design

Randomized
Start year: 2015
Treatment: 5 weeks, follow-up 10 weeks
Countries: United States (11 sites)
Sponsor: MedImmune LLC (industry)
Eligibility: age 18 to 65; type 2 diabetes; BMI 25 to 42 kg/m2; LDL-C 1.81 mmol/L or more; metformin required in Part B

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	MEDI4166 Part A MEDI4166 10 mg single dose	metformin monotherapy allowed; lifestyle: not reported	6	6
A10	Placebo Part B placebo once weekly	metformin; lifestyle: not reported	15	15
A2	MEDI4166 Part A MEDI4166 30 mg single dose	metformin monotherapy allowed; lifestyle: not reported	6	6
A3	MEDI4166 Part A MEDI4166 100 mg single dose	metformin monotherapy allowed; lifestyle: not reported	6	6
A4	MEDI4166 Part A MEDI4166 200 mg single dose	metformin monotherapy allowed; lifestyle: not reported	6	6
A5	MEDI4166 Part A MEDI4166 400 mg single dose	metformin monotherapy allowed; lifestyle: not reported	6	6
A6	Placebo Part A placebo single dose	metformin monotherapy allowed; lifestyle: not reported	10	10
A7	MEDI4166 Part B MEDI4166 50 mg once weekly	metformin; lifestyle: not reported	9	9
A8	MEDI4166 Part B MEDI4166 200 mg once weekly	metformin; lifestyle: not reported	18	18
A9	MEDI4166 Part B MEDI4166 400 mg once weekly	metformin; lifestyle: not reported	21	21

Baseline characteristics

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

Characteristic	Statistic	Part A MEDI4166 10 mg single dose A1	Part A MEDI4166 30 mg single dose A2	Part A MEDI4166 100 mg single dose A3	Part A MEDI4166 200 mg single dose A4	Part A MEDI4166 400 mg single dose A5	Placebo A6	Part B MEDI4166 50 mg once weekly A7	Part B MEDI4166 200 mg once weekly A8	Part B MEDI4166 400 mg once weekly A9	Placebo A10
age	mean (years)	54.3	58.7	55.2	55.7	57.3	58.7	58.0	55.7	55.9	56.4
age	sd (years)	6.4	5.2	7.9	6.4	5.0	3.8	7.4	5.4	7.3	4.4
black	n	3	0	0	1	0	3	1	2	4	7
black	percent	50			17		30	11	11	19	47
bmi	mean (kg/m2)	32.5	31.5	31.0	32.7	31.6	33.0	32.2	32.2	30.9	32.7
bmi	sd (kg/m2)	4.1	2.0	3.2	3.5	3.1	3.7	4.0	4.8	3.9	4.0
diabetes duration	mean (years)	11.8	8.8	8.2	9.3	12.2	7.8	10.2	9.1	9.7	9.5
diabetes duration	sd (years)	10.0	6.4	2.9	4.0	4.4	5.7	4.9	4.5	6.3	5.3
female	n	3	4	1	5	2	6	8	6	8	10
female	percent	50	67	17	83	33	60	89	33	38	67
hba1c	mean (percent)	8.3	8.2	7.8	8.0	8.4	7.7	8.6	8.2	8.2	8.3
hba1c	sd (percent)	0.7	0.5	0.9	1.0	1.0	0.6	0.8	0.8	0.8	0.9
metformin use	n	6	6	5	6	6	10	9	18	21	15
metformin use	percent	100	100	83	100	100	100	100	100	100	100
other race multiple	n							1	0	0	0
other race multiple	percent							11
sbp	mean (mmHg)	129.8	123.8	123.0	121.5	121.3	124.8	127.4	119.5	122.2	122.7
sbp	sd (mmHg)	8.7	9.6	3.4	17.4	11.2	7.8	13.7	13.1	10.7	11.8
white	n	3	6	6	5	6	7	7	16	17	8
white	percent	50	100	100	83	100	70	78	89	81	53

Results

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

All cause mortality (10 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	0 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Hospitalization for heart failure (10 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	0 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Serious adverse events (10 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	0 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	1 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	1 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Nausea (10 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 6	not stated; randomized; R0026340:Table 3
A10	events	1 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	1 / 6	not stated; randomized; R0026340:Table 3
A4	events	1 / 6	not stated; randomized; R0026340:Table 3
A5	events	1 / 6	not stated; randomized; R0026340:Table 3
A6	events	5 / 10	not stated; randomized; R0026340:Table 3
A7	events	1 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	2 / 21	not stated; randomized; R0026340:Table 4

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 6	not stated; randomized; R0026340:Table 3
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	1 / 10	not stated; randomized; R0026340:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A10	events	3 / 15	not stated; randomized; R0026340:Table 4
A7	events	4 / 9	not stated; randomized; R0026340:Table 4
A8	events	2 / 18	not stated; randomized; R0026340:Table 4
A9	events	4 / 21	not stated; randomized; R0026340:Table 4

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A10	events	3 / 15	not stated; randomized; R0026340:Table 4
A7	events	1 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Discontinuation due to gastrointestinal adverse events (10 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	1 / 15	not stated; randomized; dyspepsia; R0026340:Results
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Results
A9	events	0 / 21	not stated; randomized; R0026340:Table 4

Death by suicide (10 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 6	not stated; randomized; R0026340:Table 3
A10	events	0 / 15	not stated; randomized; R0026340:Table 4
A2	events	0 / 6	not stated; randomized; R0026340:Table 3
A3	events	0 / 6	not stated; randomized; R0026340:Table 3
A4	events	0 / 6	not stated; randomized; R0026340:Table 3
A5	events	0 / 6	not stated; randomized; R0026340:Table 3
A6	events	0 / 10	not stated; randomized; R0026340:Table 3
A7	events	0 / 9	not stated; randomized; R0026340:Table 4
A8	events	0 / 18	not stated; randomized; R0026340:Table 4
A9	events	0 / 21	not stated; randomized; R0026340:Table 4