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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04093752




Registration number
NCT04093752
Ethics application status
Date submitted
17/09/2019
Date registered
18/09/2019
Date last updated
17/06/2020

Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Scientific title
A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
Secondary ID [1] 0 0
I8F-MC-GPHO
Secondary ID [2] 0 0
17210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Insulin Glargine

Experimental: 5 mg Tirzepatide - 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly.

Experimental: 10 mg Tirzepatide - 10 mg tirzepatide administered SC once weekly.

Experimental: 15 mg Tirzepatide - 15 mg tirzepatide administered SC once weekly.

Active Comparator: Insulin Glargine - Insulin glargine administered SC once daily.


Treatment: Drugs: Tirzepatide
Administered SC

Treatment: Drugs: Insulin Glargine
Administered SC

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) - Mean Change from Baseline in HbA1c (10 mg and 15 mg)
Timepoint [1] 0 0
Baseline, Week 40
Secondary outcome [1] 0 0
Mean Change from Baseline in HbA1c (5 mg) - Mean Change from Baseline in HbA1c (5 mg)
Timepoint [1] 0 0
Baseline, Week 40
Secondary outcome [2] 0 0
Mean Change from Baseline in Body Weight - Mean Change from Baseline in Body Weight
Timepoint [2] 0 0
Baseline, Week 40
Secondary outcome [3] 0 0
Mean Change from Baseline in HbA1c - Mean Change from Baseline in HbA1c
Timepoint [3] 0 0
Baseline, Week 40
Secondary outcome [4] 0 0
Percentage of Participants Achieving an HbA1c Target Value of <7.0% - Percentage of Participants Achieving an HbA1c Target Value of <7.0%
Timepoint [4] 0 0
Week 40
Secondary outcome [5] 0 0
Mean Change from Baseline in Fasting Serum Glucose - Mean Change from Baseline in Fasting Serum Glucose
Timepoint [5] 0 0
Baseline, Week 40
Secondary outcome [6] 0 0
Mean Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values - Mean Change from Baseline in 7-Point SMBG Values
Timepoint [6] 0 0
Baseline, Week 40
Secondary outcome [7] 0 0
Percentage of Participants who Achieved Weight Loss =5% - Percentage of Participants who Achieved Weight Loss =5%
Timepoint [7] 0 0
Week 40
Secondary outcome [8] 0 0
Change from Baseline in Patient-Reported Outcomes as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) - Change from Baseline in Patient-Reported Outcomes as Measured by the DTSQ
Timepoint [8] 0 0
Baseline, Week 40
Secondary outcome [9] 0 0
Rate of Documented Symptomatic Hypoglycemic Episodes - Rate of Documented Symptomatic Hypoglycemic Episodes
Timepoint [9] 0 0
Baseline through Week 40

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus

- Treated with stable metformin with or without a sulfonylurea (metformin =1000
milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2
months

- Are insulin-naive (except for the use of insulin for treatment of gestational diabetes
or short-term use [=14 consecutive days] for acute conditions)

- HbA1c =7.5% to =11.0% at screening

- Stable weight (±5%) =3 months, and agree to not initiate a diet and/or exercise
program during the study with the intent of reducing body weight other than the
lifestyle and dietary measures for diabetes treatment

- Body mass Index (BMI) =23 kilograms per meter squared
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 diabetes mellitus

- Have history of chronic or acute pancreatitis

- Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or
non-proliferative diabetic retinopathy that requires acute treatment

- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6
months

- Have a history of ketoacidosis or hyperosmolar state/coma

- Have a known clinically significant gastric emptying abnormality, have undergone or
plan to have during the course of the study, or chronically take drugs that directly
affect GI motility

- Have acute myocardial infaction (MI), stroke or hospitalization due to congestive
heart failure (CHF) within 2 months

- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple
endocrine neoplasia syndrome type 2 (MEN-2)

- Have been treated with prescription drugs that promote weight loss or similar other
body weight loss medications including over the counter (OTC) within 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Blacktown Clinic - Blacktown
Recruitment hospital [2] 0 0
Campbelltown Medical & Dental Centre - Campbelltown
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Clinic - Kanwal
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [6] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment hospital [7] 0 0
Adelaide Medical Solutions - Woodville South
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Hebei
Country [5] 0 0
China
State/province [5] 0 0
Heilongjiang
Country [6] 0 0
China
State/province [6] 0 0
Henan
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Hunan
Country [9] 0 0
China
State/province [9] 0 0
Inner Mongolia
Country [10] 0 0
China
State/province [10] 0 0
Jiangsu
Country [11] 0 0
China
State/province [11] 0 0
Jilin
Country [12] 0 0
China
State/province [12] 0 0
Liaoning
Country [13] 0 0
China
State/province [13] 0 0
Shaanxi
Country [14] 0 0
China
State/province [14] 0 0
Shan XI
Country [15] 0 0
China
State/province [15] 0 0
Shandong
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Shanxi
Country [18] 0 0
China
State/province [18] 0 0
Sichuan
Country [19] 0 0
China
State/province [19] 0 0
Wanzhou
Country [20] 0 0
China
State/province [20] 0 0
Yuzhong District
Country [21] 0 0
China
State/province [21] 0 0
Zhejiang
Country [22] 0 0
China
State/province [22] 0 0
Nanchang
Country [23] 0 0
China
State/province [23] 0 0
Pingxiang
Country [24] 0 0
China
State/province [24] 0 0
Tianjin
Country [25] 0 0
China
State/province [25] 0 0
Zhengzhou
Country [26] 0 0
China
State/province [26] 0 0
Zigong
Country [27] 0 0
India
State/province [27] 0 0
Maharashtra
Country [28] 0 0
India
State/province [28] 0 0
West Bengal
Country [29] 0 0
India
State/province [29] 0 0
New Delhi
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gangdong-gu
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Geonggi-do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Gyeonggi-do
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Gyeonggido
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Kang Won-do, Korea
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Korea
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul-teukbyeolsi
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Taegu-Kwangyokshi
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Kyunggi-Do
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main reason for this study is to compare the study drug tirzepatide to insulin glargine
in participants with type 2 diabetes on metformin with or without a sulfonylurea.
Trial website
https://clinicaltrials.gov/show/NCT04093752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04093752