parallel randomized trial

NCT04552470

AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS

Type 2 diabetes (adults)NCT04552470S001336

Design

Randomized: 37
Start year: 2020
Treatment: 8 weeks, follow-up 12 weeks
Countries: Japan (1 sites)
Sponsor: Pfizer (industry)
Eligibility: Japanese adults 20 to 70, diet and exercise only, HbA1c 7 to 10.5 percent, BMI 22.5 to 45.4

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet and exercise; lifestyle: not reported	9	9
A2	Danuglipron 40 mg oral twice daily Danuglipron 40 mg twice daily	diet and exercise; lifestyle: not reported	10	10
A3	Danuglipron 80 mg oral twice daily Danuglipron 80 mg twice daily	diet and exercise; lifestyle: not reported	9	9
A4	Danuglipron 120 mg oral twice daily Danuglipron 120 mg twice daily	diet and exercise; lifestyle: not reported	9	9

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Danuglipron 40 mg oral twice daily A2	Danuglipron 80 mg oral twice daily A3	Danuglipron 120 mg oral twice daily A4
age	mean (years)	58.6	55.9	58.0	50.7
age	sd (years)	8.8	10.0	6.7	7.5
asian	n	9	10	9	9
asian	percent	100.0	100.0	100.0	100.0
bmi	mean (kg/m2)	25.9	28.6	28.2	28.6
bmi	sd (kg/m2)	2.7	4.1	3.6	3.4
diabetes duration	mean (years)	5.5	2.9	9.1	5.7
diabetes duration	sd (years)	4.1	2.2	5.8	7.7
female	n	1	2	1	1
female	percent	11.1	20.0	11.1	11.1
hba1c	mean (percent)	8.3	8.2	8.6	8.4
hba1c	sd (percent)	1.2	1.1	1.0	1.2
weight	mean (kg)	73.3	79.7	79.6	81.5
weight	sd (kg)	9.9	13.6	10.0	10.4

Analyses this trial contributes to

Results

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

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A1	change	-0.14 percent		-0.56 to 0.28	9	not stated; other; R0004540:Table 3
8	A1	change	-0.18 percent	0.21		9	not stated; other; R0004540:Table 3
8	A2	change	-1.34 percent		-1.76 to -0.92	10	not stated; other; R0004540:Table 3
8	A2	change	-1.29 percent	0.58		10	not stated; other; R0004540:Table 3
8	A2 vs A1	md	-1.20 percent		-1.80 to -0.61		not stated; other; R0004540:Table 3
8	A3	change	-1.00 percent		-1.42 to -0.57	9	not stated; other; R0004540:Table 3
8	A3	change	-1.40 percent	0.89		9	not stated; other; R0004540:Table 3
8	A3 vs A1	md	-0.86 percent		-1.46 to -0.26		not stated; other; R0004540:Table 3
8	A4	change	-1.55 percent		-1.97 to -1.13	9	not stated; other; R0004540:Table 3
8	A4	change	-1.60 percent	1.15		9	not stated; other; R0004540:Table 3
8	A4 vs A1	md	-1.41 percent		-2.01 to -0.82		not stated; other; R0004540:Table 3

Body weight change in kilograms (diabetes) (11 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A1	change	-1.21 kg		-2.36 to -0.05	9	not stated; safety; R0004540:Table 3
8	A1	change	-0.93 kg	0.94		9	not stated; safety; R0004540:Table 3
8	A2	change	-2.61 kg		-3.77 to -1.45	10	not stated; safety; R0004540:Table 3
8	A2	change	-2.47 kg	1.37		10	not stated; safety; R0004540:Table 3
8	A2 vs A1	md	-1.40 kg		-3.03 to 0.23		not stated; safety; R0004540:Table 3
8	A3	change	-3.08 kg		-4.30 to -1.86	9	not stated; safety; R0004540:Table 3
8	A3	change	-3.68 kg	2.26		9	not stated; safety; R0004540:Table 3
8	A3 vs A1	md	-1.87 kg		-3.58 to -0.17		not stated; safety; R0004540:Table 3
8	A4	change	-2.87 kg		-3.98 to -1.75	9	not stated; safety; R0004540:Table 3
8	A4	change	-3.26 kg	2.95		9	not stated; safety; R0004540:Table 3
8	A4 vs A1	md	-1.66 kg		-3.28 to -0.04		not stated; safety; R0004540:Table 3

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Results
A2	events	1 / 10	not stated; safety; R0004540:Results
A3	events	0 / 9	not stated; safety; R0004540:Results
A4	events	0 / 9	not stated; safety; R0004540:Results

Weight loss of 5 percent or more (4 lines; O11A)

Week	Arm	Statistic	Events / N	Detail
8	A1	responders	0 / 8	not stated; safety; R0004540:Supplement Table S2
8	A2	responders	1 / 7	not stated; safety; R0004540:Supplement Table S2
8	A3	responders	2 / 6	not stated; safety; R0004540:Supplement Table S2
8	A4	responders	4 / 8	not stated; safety; R0004540:Supplement Table S2

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Supplement Table S1
A2	events	0 / 10	not stated; safety; R0004540:Supplement Table S1
A3	events	0 / 9	not stated; safety; R0004540:Supplement Table S1
A4	events	0 / 9	not stated; safety; R0004540:Supplement Table S1

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Supplement Table S1
A2	events	0 / 10	not stated; safety; R0004540:Supplement Table S1
A3	events	0 / 9	not stated; safety; R0004540:Supplement Table S1
A4	events	0 / 9	not stated; safety; R0004540:Supplement Table S1

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Supplement Table S1
A2	events	2 / 10	not stated; safety; R0004540:Supplement Table S1
A3	events	3 / 9	not stated; safety; R0004540:Supplement Table S1
A4	events	1 / 9	not stated; safety; R0004540:Supplement Table S1

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Table 2
A2	events	6 / 10	not stated; safety; R0004540:Table 2
A3	events	8 / 9	not stated; safety; R0004540:Table 2
A4	events	4 / 9	not stated; safety; R0004540:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Table 2
A2	events	5 / 10	not stated; safety; R0004540:Table 2
A3	events	6 / 9	not stated; safety; R0004540:Table 2
A4	events	5 / 9	not stated; safety; R0004540:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Table 2
A2	events	1 / 10	not stated; safety; R0004540:Table 2
A3	events	2 / 9	not stated; safety; R0004540:Table 2
A4	events	1 / 9	not stated; safety; R0004540:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0004540:Results
A2	events	2 / 10	not stated; safety; R0004540:Results
A3	events	3 / 9	not stated; safety; R0004540:Supplement Table S1
A4	events	1 / 9	not stated; safety; R0004540:Results