Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2) (NCT NCT05706506)

NCT ID: NCT05706506

Last Updated: 2024-12-13

Results Overview

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 152 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2024-12-13

Participant Flow

Participant milestones

Measure	5 Milligrams (mg) Tirzepatide Participants received 5 mg tirzepatide subcutaneously (SC) administered once weekly (QW) for 12 weeks.
Overall Study STARTED	152
Overall Study Received At Least 1 Dose of Study Drug	152
Overall Study COMPLETED	131
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Measure	5 Milligrams (mg) Tirzepatide Participants received 5 mg tirzepatide subcutaneously (SC) administered once weekly (QW) for 12 weeks.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	2
Overall Study Inadvertent Enrolment	12
Overall Study Early Discontinuation Due to Hyperglycemia	1
Overall Study Participant Moved Out of State	1

Baseline Characteristics

A Study of Tirzepatide (LY3298176) in Adults With Type 2 Diabetes Switching From a GLP-1 RA (SURPASS-SWITCH-2)

Baseline characteristics by cohort

Measure	5 mg Tirzepatide n=152 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Age, Continuous	58.1 years STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	152 Participants n=5 Participants
Hemoglobin A1c (HbA1c)	7.40 Percentage of HbA1c STANDARD_DEVIATION 0.660 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least one dose of tirzepatide, had a baseline and had evaluable data for this outcome.

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Hemoglobin A1c (HbA1c)	-0.43 Percentage of HbA1c Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))	-6.52 Percentage of time per day Standard Error 1.55

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in Percentage of Time per Day that CGM-derived Values were >180 mg/dl (10 mmol/L) was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)	-7.37 Percentage of time per day Standard Error 1.54

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)	-93.82 Minutes per day Standard Error 22.30

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were >180 mg/dl (10 mmol/L) was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)	-106.09 Minutes per day Standard Error 22.21

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in FSG was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Fasting Serum Glucose (FSG)	-7.83 milligrams per deciliter (mg/dL) Standard Error 2.85

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.

Change from Baseline in Weight was assessed.

Outcome measures

Measure	5 mg Tirzepatide n=140 Participants Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Change From Baseline in Weight	-2.15 kilograms (kg) Standard Error 0.28

Adverse Events

5 mg Tirzepatide

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	5 mg Tirzepatide n=152 participants at risk Participants received 5 mg tirzepatide SC administered QW for 12 weeks.
Cardiac disorders Coronary artery disease	0.66% 1/152 • Number of events 1 • Baseline Up To 12 Weeks All participants who received at least one dose of tirzepatide.
Injury, poisoning and procedural complications Wound dehiscence	0.66% 1/152 • Number of events 1 • Baseline Up To 12 Weeks All participants who received at least one dose of tirzepatide.

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60