parallel randomized trial

NCT03311724

A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT03311724S002256

Design

Randomized: 111
Start year: 2017
Treatment: 12 weeks, follow-up 16 weeks
Countries: United States (13 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 75; T2D at least 6 months; HbA1c 7.0 to 10.5%; BMI 23 to 45; diet or stable metformin

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	diet and exercise or stable metformin; lifestyle: not reported	26	26	20
A2	Tirzepatide 12 mg injection once weekly TZP 12 mg	diet and exercise or stable metformin; lifestyle: not reported	29	29	27
A3	Tirzepatide 15 mg subcutaneous once weekly TZP 15 mg-1	diet and exercise or stable metformin; lifestyle: not reported	28	28	22
A4	Tirzepatide 15 mg subcutaneous once weekly TZP 15 mg-2	diet and exercise or stable metformin; lifestyle: not reported	28	28	26

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 12 mg injection once weekly A2	Tirzepatide 15 mg subcutaneous once weekly A3	Tirzepatide 15 mg subcutaneous once weekly A4
age	mean (years)	56.0	61.2	55.5	56.6
age	sd (years)	10.13	7.56	8.54	9.21
asian	n	0	1	2	1
black	n	1	7	5	2
bmi	mean (kg/m2)	32.5	32.0	32.0	31.1
bmi	sd (kg/m2)	5.70	5.19	5.56	4.21
diabetes duration	mean (years)	8.8	10.5	8.2	8.9
diabetes duration	sd (years)	6.43	7.90	4.87	6.35
female	n	14	14	12	5
hba1c	mean (percent)	8.2	8.4	8.5	8.4
hba1c	sd (percent)	1.22	0.90	1.17	1.12
hispanic	n	16	15	14	14
metformin use	n	23	25	25	23
metformin use	percent	88.5	86.2	89.3	82.1
other race american indian alaska native	n	0	2	1	0
other race multiple	n	0	0	0	2
other race native hawaiian pacific islander	n	0	0	0	0
waist	mean (cm)	109.1	107.7	107.0	105.1
waist	sd (cm)	15.38	12.23	12.65	12.19
weight	mean (kg)	89.6	88.0	88.7	89.6
weight	sd (kg)	23.70	17.35	18.21	16.91
white	n	25	19	20	23

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	0.2 percent	0.21		20	hypothetical; modified itt; R0010282:Abstract
12	A2	change	-1.7 percent	0.19		27	hypothetical; modified itt; R0010282:Abstract
12	A2 vs A1	md	-1.9 percent		-2.5 to -1.4		hypothetical; modified itt; R0010282:Results
12	A3	change	-2.0 percent	0.20		23	hypothetical; modified itt; R0010282:Abstract
12	A3 vs A1	md	-2.2 percent		-2.8 to -1.7		hypothetical; modified itt; R0010282:Results
12	A4	change	-1.8 percent	0.19		26	hypothetical; modified itt; R0010282:Abstract
12	A4 vs A1	md	-2.0 percent		-2.5 to -1.4		hypothetical; modified itt; R0010282:Results

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.5 kg	0.86		20	hypothetical; modified itt; registry:outcomes
12	A2	change	-5.3 kg	0.78		27	hypothetical; modified itt; registry:outcomes
12	A2 vs A1	md	-4.8 kg		-7.1 to -2.6		hypothetical; modified itt; R0010282:Results
12	A3	change	-5.5 kg	0.80		23	hypothetical; modified itt; registry:outcomes
12	A3 vs A1	md	-5.0 kg		-7.2 to -2.7		hypothetical; modified itt; R0010282:Results
12	A4	change	-5.7 kg	0.79		26	hypothetical; modified itt; registry:outcomes
12	A4 vs A1	md	-5.2 kg		-7.5 to -2.9		hypothetical; modified itt; R0010282:Results

HbA1c below 7 percent (7 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	responders	10		20	hypothetical; modified itt; registry:outcomes
12	A2	responders	74.1		27	hypothetical; modified itt; registry:outcomes
12	A2 vs A1	or	56.54	9.43 to 338.97		hypothetical; modified itt; registry:outcomes
12	A3	responders	87		23	hypothetical; modified itt; registry:outcomes
12	A3 vs A1	or	183.48	22.0 to 999		hypothetical; modified itt; registry:outcomes
12	A4	responders	84.6		26	hypothetical; modified itt; registry:outcomes
12	A4 vs A1	or	157.54	21.63 to 999		hypothetical; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (12 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A2	events	2 / 29	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A3	events	5 / 28	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	5 / 28	not stated; modified itt; R0010282:Table 2

Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)

Arm	Statistic	Events / N	Detail
A1	rate	26	not stated; modified itt; registry:outcomes
A2	rate	29	not stated; modified itt; registry:outcomes
A3	rate	28	not stated; modified itt; registry:outcomes
A4	rate	28	not stated; modified itt; registry:outcomes

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2

Three point MACE (4 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Four point MACE including unstable angina (4 lines; O21B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Hospitalization for heart failure (4 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Heart failure events (4 lines; O23B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	1 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2

Discontinuation due to adverse events (8 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 26	not stated; modified itt; R0010282:Table 2
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	1 / 29	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A3	events	1 / 28	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 26	not stated; modified itt; R0010282:Table 2
A2	events	7 / 29	not stated; modified itt; R0010282:Table 2
A3	events	11 / 28	not stated; modified itt; R0010282:Table 2
A4	events	10 / 28	not stated; modified itt; R0010282:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 26	not stated; modified itt; R0010282:Table 2
A2	events	5 / 29	not stated; modified itt; R0010282:Table 2
A3	events	5 / 28	not stated; modified itt; R0010282:Table 2
A4	events	5 / 28	not stated; modified itt; R0010282:Table 2

Diarrhea (8 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 26	not stated; modified itt; R0010282:Table 2
A1	events	0 / 26	not stated; safety; registry:adverse_events
A2	events	1 / 29	not stated; safety; registry:adverse_events
A2	events	9 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; safety; registry:adverse_events
A3	events	10 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; safety; registry:adverse_events
A4	events	9 / 28	not stated; modified itt; R0010282:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	1 / 29	not stated; modified itt; R0010282:Table 2
A3	events	3 / 28	not stated; modified itt; R0010282:Table 2
A4	events	5 / 28	not stated; modified itt; R0010282:Table 2

Discontinuation due to gastrointestinal adverse events (8 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	1 / 29	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A3	events	1 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; cholecystitis; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; cholecystitis; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; cholecystitis; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; cholecystitis; R0010282:Table 2

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2

Medullary thyroid carcinoma (4 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Table 2
A2	events	0 / 29	not stated; modified itt; R0010282:Table 2
A3	events	0 / 28	not stated; modified itt; R0010282:Table 2
A4	events	0 / 28	not stated; modified itt; R0010282:Table 2

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results

Any cancer (4 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; modified itt; R0010282:Results
A2	events	0 / 29	not stated; modified itt; R0010282:Results
A3	events	0 / 28	not stated; modified itt; R0010282:Results
A4	events	0 / 28	not stated; modified itt; R0010282:Results