parallel randomized trial

NCT03550378

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects With Type 2 Diabetes Mellitus and Renal Impairment

Type 2 diabetes (adults)Chronic kidney disease with diabetes NCT03550378S002039

Design

Randomized: 41
Start year: 2018
Treatment: 4.57 weeks, follow-up 8.57 weeks
Countries: United Kingdom, Germany (7 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 18 to 84; BMI 25 to 45; eGFR 30 to 59; HbA1c 6.5 to 10.5 percent

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: available data only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Cotadutide 300 ug subcutaneous once daily Cotadutide 300 ug daily	insulin and or oral glucose lowering drugs; lifestyle: not reported	21	18
A2	Placebo Placebo	insulin and or oral glucose lowering drugs; lifestyle: not reported	20	20

Baseline characteristics

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

Characteristic	Statistic	Cotadutide 300 ug subcutaneous once daily A1	Placebo A2
age	mean (years)	71.1	70.9
age	sd (years)	7.4	4.7
asian	n	0	0
black	n	0	0
bmi	mean (kg/m2)	32.4	32.9
bmi	sd (kg/m2)	4.1	5.5
diabetes duration	mean (years)	16.3	15.9
diabetes duration	sd (years)	8.5	7.2
egfr	mean (mL/min/1.73 m2)	44.7	47.6
egfr	sd (mL/min/1.73 m2)	8.7	8.8
female	n	9	11
female	percent	42.9	55.0
hba1c	mean (percent)	7.85	7.88
hba1c	sd (percent)	0.7	1.3
hispanic	n	0	0
insulin dose: 20 or more	n	14	14
insulin dose: 20 or more	percent	66.7	70.0
insulin dose: less than 20	n	7	6
insulin dose: less than 20	percent	33.3	30.0
metformin use	n	11	9
metformin use	percent	52.4	45.0
other acei arb use	n	16	16
other acei arb use	percent	76.2	80.0
other dpp4i use	n	2	3
other dpp4i use	percent	9.5	15.0
other race american indian alaska native	n	0	0
other race multiple	n	0	0
other race native hawaiian pacific islander	n	1	0
other sulfonylurea glinide use	n	6	5
other sulfonylurea glinide use	percent	28.6	25.0
sglt2i use	n	4	2
sglt2i use	percent	19.0	10.0
weight	mean (kg)	94.7	91.6
weight	sd (kg)	17.6	15.8
white	n	20	20

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
4.43	A1	change	-0.65 percent	-0.82 to -0.49	19	not stated; full analysis; registry:outcomes
4.43	A1	change	-0.65 percent		19	not stated; full analysis; R0019218:Results
4.43	A2	change	0.01 percent		20	not stated; full analysis; R0019218:Results
4.43	A2	change	0.01 percent	-0.15 to 0.17	20	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
4.57	A1	change	-3.41 kg		-4.2 to -2.62	19	not stated; full analysis; R0019218:Results
4.57	A1	change	-3.39 kg	2.16		19	not stated; full analysis; registry:outcomes
4.57	A2	change	-0.13 kg		-0.9 to 0.64	20	not stated; full analysis; R0019218:Results
4.57	A2	change	-0.15 kg	1.84		20	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	3 / 21	not stated; safety; R0019218:Table 2
A1	events	0 / 21	not stated; safety; R0019218:Results
A2	events	0 / 20	not stated; safety; R0019218:Results
A2	events	1 / 20	not stated; safety; R0019218:Table 2

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
4.43	A1	change	1.44 mmHg			not stated; other; R0019218:Results
4.43	A1	change	-1.15 mmHg	18.43	21	not stated; safety; registry:outcomes
4.43	A2	change	2.21 mmHg	7.24	20	not stated; safety; registry:outcomes
4.43	A2	change	8.69 mmHg			not stated; other; R0019218:Results

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
4.57	A1	percent change	-3.69 percent	-4.55 to -2.83	19	not stated; full analysis; registry:outcomes
4.57	A1	percent change	-3.69 percent	-4.55 to -2.83	19	not stated; full analysis; R0019218:Results
4.57	A2	percent change	-0.21 percent	-1.05 to 0.62	20	not stated; full analysis; R0019218:Results
4.57	A2	percent change	-0.21 percent	-1.05 to 0.62	20	not stated; full analysis; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 21	not stated; safety; R0019218:Table 2
	A2	events				0 / 20	not stated; safety; R0019218:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 21	not stated; safety; R0019218:Table 2
	A2	events				2 / 20	not stated; safety; R0019218:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 21	not stated; safety; R0019218:Results
	A2	events				1 / 20	not stated; safety; R0019218:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 21	not stated; safety; R0019218:Table 2
	A2	events				4 / 20	not stated; safety; R0019218:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 21	not stated; safety; R0019218:Table 2
	A2	events				1 / 20	not stated; safety; R0019218:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 21	not stated; safety; R0019218:Table 2
	A2	events				0 / 20	not stated; safety; R0019218:Table 2

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 21	not stated; safety; cholecystitis; R0019218:Results

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0019218:Table 2