parallel randomized trial

NCT03322631

A Multiple-Ascending Dose Study in Japanese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176

Type 2 diabetes (adults)NCT03322631S001634

Design

Randomized: 48
Start year: 2017
Treatment: 8 weeks, follow-up 12 weeks
Countries: Japan
Sponsor: Eli Lilly and Company (industry)
Eligibility: Japanese adults 20 to 70; T2D 1 year or more on diet or metformin or DPP-4 inhibitor (washed out); BMI 20 to 35

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: safety
Missing data: mixed model

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	none (washout of prior metformin or DPP-4 inhibitor); lifestyle: not reported	9	9
A2	Tirzepatide 5 mg subcutaneous once weekly Tirzepatide 5 mg	none (washout of prior metformin or DPP-4 inhibitor); lifestyle: not reported	11	11
A3	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	none (washout of prior metformin or DPP-4 inhibitor); lifestyle: not reported	12	12
A4	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	none (washout of prior metformin or DPP-4 inhibitor); lifestyle: not reported	16	16

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 5 mg subcutaneous once weekly A2	Tirzepatide 10 mg subcutaneous once weekly A3	Tirzepatide 15 mg subcutaneous once weekly A4
age	mean (years)	57.4	57.5	56.9	57.7
age	sd (years)	11.6	7.9	9.5	8.0
asian	n	9	11	12	16
black	n	0	0	0	0
bmi	mean (kg/m2)	22.6	26.7	25.5	26.1
bmi	sd (kg/m2)	2.1	3.3	2.8	3.1
diabetes duration	mean (years)	9.5	7.0	8.4	9.1
diabetes duration	sd (years)	3.4	5.0	3.8	4.8
female	n	0	0	0	1
female	percent				6.3
hba1c	mean (percent)	7.8	7.7	8.1	8.2
hba1c	sd (percent)	0.9	0.3	0.8	0.9
hispanic	n	0	0	0	0
other race american indian alaska native	n	0	0	0	0
other race multiple	n	0	0	0	0
other race native hawaiian pacific islander	n	0	0	0	0
weight	mean (kg)	63.0	75.4	74.9	73.3
weight	sd (kg)	7.8	11.0	9.5	9.9
white	n	0	0	0	0

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Detail
8	A1 vs A3	md	1.3 percent	0.9 to 1.7	not stated; modified itt; R0021917:Results
8	A1 vs A2	md	1.1 percent	0.8 to 1.5	not stated; modified itt; R0021917:Results
8	A1 vs A4	md	1.6 percent	1.2 to 1.9	not stated; modified itt; R0021917:Results

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

Week	Arm	Statistic	Estimate	95% CI	Detail
8	A1 vs A2	md	3.4 kg	2.0 to 4.8	not stated; modified itt; R0021917:Results
8	A1 vs A3	md	5.0 kg	3.6 to 6.5	not stated; modified itt; R0021917:Results
8	A1 vs A4	md	6.6 kg	5.3 to 7.9	not stated; modified itt; R0021917:Results

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Results
A2	events	1 / 11	not stated; safety; R0021917:Results
A2	events	0 / 11	not stated; safety; R0021917:Results
A3	events	0 / 12	not stated; safety; R0021917:Results
A4	events	0 / 16	not stated; safety; R0021917:Results
A4	events	3 / 16	not stated; safety; R0021917:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Results
A2	events	0 / 11	not stated; safety; R0021917:Results
A3	events	0 / 12	not stated; safety; R0021917:Results
A4	events	0 / 16	not stated; safety; R0021917:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Results
A2	events	0 / 11	not stated; safety; R0021917:Results
A3	events	0 / 12	not stated; safety; R0021917:Results
A4	events	0 / 16	not stated; safety; R0021917:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; randomized; registry:flow
A2	events	0 / 11	not stated; randomized; registry:flow
A3	events	0 / 12	not stated; randomized; registry:flow
A4	events	1 / 16	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Table 2
A2	events	1 / 11	not stated; safety; R0021917:Table 2
A3	events	0 / 12	not stated; safety; R0021917:Table 2
A4	events	2 / 16	not stated; safety; R0021917:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Table 2
A2	events	1 / 11	not stated; safety; R0021917:Table 2
A3	events	1 / 12	not stated; safety; R0021917:Table 2
A4	events	2 / 16	not stated; safety; R0021917:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	0 / 9	not stated; safety; R0021917:Table 2
A2	events	0 / 11	not stated; safety; R0021917:Table 2
A3	events	3 / 12	not stated; safety; R0021917:Table 2
A4	events	5 / 16	not stated; safety; R0021917:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 9	not stated; safety; R0021917:Table 2
A2	events	0 / 11	not stated; safety; R0021917:Table 2
A3	events	8 / 12	not stated; safety; R0021917:Table 2
A4	events	8 / 16	not stated; safety; R0021917:Table 2