crossover randomized trial

NCT04050553

A Randomized, Placebo-Controlled, Crossover Study to Investigate the Effect of Once-Weekly Tirzepatide on the Counter-Regulatory Response to Hypoglycemia in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT04050553S000183

Design

Randomized: 42
Start year: 2020
Treatment: 12 weeks, follow-up 36 weeks
Countries: Austria (1 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 70; T2D on metformin; HbA1c 6.5 to 9.0 (6.0 to 8.5 with second oral drug); BMI 23 to 45

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	metformin; lifestyle: not reported		33
A2	Placebo Placebo	metformin; lifestyle: not reported		33

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age population:randomized	mean (years)	57.1
age population:randomized	sd (years)	6.4
age	mean (years)	57.5
age	sd (years)	5.5
asian population:randomized	n	0
bmi	mean (kg/m2)	30.9
bmi	sd (kg/m2)	4.1
diabetes duration	mean (years)	8.2
diabetes duration	sd (years)	4.7
female population:randomized	n	9
female	n	5
female	percent	15.2
hba1c	mean (percent)	7.5
hba1c	sd (percent)	0.8
hispanic population:randomized	n	0
other not hispanic	percent	100.0
sbp	mean (mmHg)	135.8
sbp	sd (mmHg)	13.7
weight	mean (kg)	94.7
weight	sd (kg)	14.4
white population:randomized	n	42
white	n	33
white	percent	100.0

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.5 percent				not stated; other; R0015435:Results
12	A2	change	0.5 percent				not stated; other; R0015435:Results

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-7.6 kg				not stated; other; R0015435:Results
12	A2	change	1.3 kg				not stated; other; R0015435:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; safety; R0015435:Results
	A2	events				0 / 36	not stated; safety; R0015435:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 39	not stated; safety; registry:adverse_events
	A2	events				0 / 36	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 39	not stated; safety; registry:adverse_events
	A2	events				0 / 36	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 39	not stated; safety; R0015435:Results
	A2	events				1 / 36	not stated; safety; R0015435:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 39	not stated; safety; registry:adverse_events
	A2	events				2 / 36	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 39	not stated; safety; registry:adverse_events
	A2	events				1 / 36	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 39	not stated; safety; registry:adverse_events
	A2	events				4 / 36	not stated; safety; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 39	not stated; safety; obstructive pancreatitis; registry:adverse_events
	A2	events				0 / 36	not stated; safety; obstructive pancreatitis; registry:adverse_events