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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04093752
Ethics application status
Date submitted
17/09/2019
Date registered
18/09/2019

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 - Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).

Experimental: 10 mg Tirzepatide - Participants received 10 mg tirzepatide administered SC QW.

Experimental: 15 mg Tirzepatide - Participants received 15 mg tirzepatide administered SC QW.

Active comparator: Insulin Glargine - Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.


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)
Timepoint [1] 0 0
Baseline, Week 40
Secondary outcome [1] 0 0
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
Timepoint [2] 0 0
Baseline, Week 40
Secondary outcome [3] 0 0
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
Timepoint [3] 0 0
Week 40
Secondary outcome [4] 0 0
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
Timepoint [4] 0 0
Week 40
Secondary outcome [5] 0 0
Mean Change From Baseline in Fasting Serum Glucose
Timepoint [5] 0 0
Baseline, Week 40
Secondary outcome [6] 0 0
Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
Timepoint [6] 0 0
Baseline, Week 40
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved Weight Loss =5%
Timepoint [7] 0 0
Week 40
Secondary outcome [8] 0 0
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
Timepoint [8] 0 0
Baseline, Week 40
Secondary outcome [9] 0 0
Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
Timepoint [9] 0 0
Baseline through end of safety follow-up (Up To Week 44)

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
Sex
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 infarction (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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/11/2021
Sample size
Target
Accrual to date
Final
917
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [4] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [5] 0 0
Core Research Group - Milton
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
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4064 - Milton
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
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangdong
Country [3] 0 0
China
State/province [3] 0 0
Hebei
Country [4] 0 0
China
State/province [4] 0 0
Heilongjiang
Country [5] 0 0
China
State/province [5] 0 0
Henan
Country [6] 0 0
China
State/province [6] 0 0
Hunan
Country [7] 0 0
China
State/province [7] 0 0
Inner Mongolia
Country [8] 0 0
China
State/province [8] 0 0
Jiangsu
Country [9] 0 0
China
State/province [9] 0 0
Jiangxi
Country [10] 0 0
China
State/province [10] 0 0
Jilin
Country [11] 0 0
China
State/province [11] 0 0
Liaoning
Country [12] 0 0
China
State/province [12] 0 0
Shaanxi
Country [13] 0 0
China
State/province [13] 0 0
Shan XI
Country [14] 0 0
China
State/province [14] 0 0
Shandong
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Shanxi
Country [17] 0 0
China
State/province [17] 0 0
Sichuan
Country [18] 0 0
China
State/province [18] 0 0
Tianjin
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
Pingxiang
Country [23] 0 0
China
State/province [23] 0 0
Zigong
Country [24] 0 0
India
State/province [24] 0 0
Maharashtra
Country [25] 0 0
India
State/province [25] 0 0
West Bengal
Country [26] 0 0
India
State/province [26] 0 0
Delhi
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gangdong-gu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Geonggi-do
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Gyeonggi-do
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeonggido
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Korea
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul-teukbyeolsi
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Taegu-Kwangyokshi
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Ansan-si
Country [35] 0 0
Korea, Republic of
State/province [35] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04093752