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出境医 / 临床实验 / A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes (SURPASS-2)

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes (SURPASS-2)

Study Description
Brief Summary:
The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Semaglutide Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : January 28, 2021
Actual Study Completion Date : February 15, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Active Comparator: Semaglutide
Semaglutide administered SC once a week.
 Drug: Semaglutide
Administered SC
Outcome Measures
Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in HbA1c (10 mg and 15 mg)


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (5 mg) [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in HbA1c

  2. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Body Weight

  3. Percentage of Participants Achieving an HbA1c Target Value of <7% [ Time Frame: Week 40 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7%

  4. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Fasting Serum Glucose

  5. Mean Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 40 ]
    Mean Change from Baseline in Daily Average 7-Point SMBG Values

  6. Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 40 ]
    Percentage of Participants who Achieved Weight Loss ≥5%

  7. Change from Baseline in Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Diabetes Treatment Satisfaction as Measured by the DTSQ

  8. Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 40 ]
    Rate of Documented Symptomatic Hypoglycemic Episodes


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 >1500 mg/day for at least 3 months prior to screening
  • Be of stable weight (±5%) for at least 3 months before screening
  • Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

  • 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 milliliters/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 during the last 3 months
  • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Contacts and Locations

Locations
Show Show 127 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE July 30, 2019
Actual Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]
Change from Baseline in HbA1c (10 mg and 15 mg)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Change from Baseline in HbA1c (5 mg) [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in HbA1c
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Body Weight
  • Percentage of Participants Achieving an HbA1c Target Value of <7% [ Time Frame: Week 40 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7%
  • Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Fasting Serum Glucose
  • Mean Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 40 ]
    Mean Change from Baseline in Daily Average 7-Point SMBG Values
  • Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 40 ]
    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 40 ]
    Change from Baseline in Diabetes Treatment Satisfaction as Measured by the DTSQ
  • Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 40 ]
    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 Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes
Official Title  ICMJE A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Brief Summary The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 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
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Semaglutide
    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: Semaglutide
    Semaglutide administered SC once a week.
    Intervention: Drug: Semaglutide
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2021) 		1878
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2019) 		1872
Actual Study Completion Date  ICMJE February 15, 2021
Actual Primary Completion Date January 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 >1500 mg/day for at least 3 months prior to screening
  • Be of stable weight (±5%) for at least 3 months before screening
  • Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Exclusion Criteria:

  • 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 milliliters/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 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Israel,   Mexico,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987919
Other Study ID Numbers  ICMJE 17001
I8F-MC-GPGL ( Other Identifier: Eli Lilly and Company )
2018-004422-29 ( EudraCT Number )
Has Data Monitoring Committee No
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 March 2021

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

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