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A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes (SURPASS-3)

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ClinicalTrials.gov Identifier: NCT03882970
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE March 20, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 52 ]
Change from Baseline in HbA1c (10 mg and 15 mg)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03882970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Change from Baseline in HbA1c [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HbA1c
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Body Weight
  • Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Fasting Serum Glucose
  • Percentage of Participants Achieving an HbA1c Target Value of <7% [ Time Frame: Week 52 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7%
  • Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in 7-Point SMBG Values
  • Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 52 ]
    Percentage of Participants who Achieved Weight Loss ≥5%
  • Change from Baseline in Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Diabetes Treatment Satisfaction as Measured by the DTSQ
  • Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 52 ]
    Rate of Documented Symptomatic Hypoglycemic Episodes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Official Title  ICMJE A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes
Brief Summary The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 59 weeks and may include up to 22 visits.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Insulin Degludec
    Administered SC
Study Arms  ICMJE
  • Experimental: 5 mg Tirzepatide
    5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
    Intervention: Drug: Tirzepatide
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once a week.
    Intervention: Drug: Tirzepatide
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once a week.
    Intervention: Drug: Tirzepatide
  • Active Comparator: Insulin Degludec
    Insulin degludec administered SC once a day.
    Intervention: Drug: Insulin Degludec
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
1420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 8, 2021
Estimated Primary Completion Date October 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must:

    • Have been diagnosed with type 2 diabetes mellitus (T2DM)
    • Have HbA1c between ≥7.0% and ≤10.5%
    • Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
    • Be of stable weight (± 5%) for at least 3 months before screening
    • Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

  • Participants must not:

    • Have type 1 diabetes mellitus
    • Have had chronic or acute pancreatitis any time prior to study entry
    • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
    • Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
    • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
    • Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
    • Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
    • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
    • Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
    • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Austria,   Greece,   Hungary,   Italy,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   Spain,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03882970
Other Study ID Numbers  ICMJE 16997
I8F-MC-GPGH ( Other Identifier: Eli Lilly and Company )
2018-003422-84 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP