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出境医 / 临床实验 / A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)

Study Description
Brief Summary:
The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : October 5, 2020
Actual Study Completion Date : October 28, 2020
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
Placebo Comparator: Placebo
Placebo administered SC once a week.
 Drug: Placebo
Administered SC
Outcome Measures
Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in HbA1c


Secondary Outcome Measures :
  1. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Body Weight

  2. Percentage of Participants with HbA1c Target Value of <7% [ Time Frame: Week 40 ]
    Percentage of Participants with HbA1c Target Value of <7%

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

  4. Percentage of Participants with HbA1c Target Value of <5.7% [ Time Frame: Week 40 ]
    Percentage of Participants with HbA1c Target Value of <5.7%

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

  8. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 40 ]
    PK: Steady state AUC of tirzepatide


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).
  • Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
  • Have HbA1c between ≥7.0% and ≤9.5%.
  • Be of stable weight (± 5%) for at least 3 months before screening.
  • Have a BMI ≥23 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 an estimated glomerular filtration rate <30 mL/minute/1.73 m².
  • 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 weight loss drugs, including over-the-counter medications during the last 3 months.
Contacts and Locations

Locations
Show Show 53 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 May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date November 2, 2020
Actual Study Start Date  ICMJE June 3, 2019
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019) 		Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]
Change from Baseline in HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Change from Baseline in Body Weight [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Body Weight
  • Percentage of Participants with HbA1c Target Value of <7% [ Time Frame: Week 40 ]
    Percentage of Participants with HbA1c Target Value of <7%
  • Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 40 ]
    Change from Baseline in Fasting Serum Glucose
  • Percentage of Participants with HbA1c Target Value of <5.7% [ Time Frame: Week 40 ]
    Percentage of Participants with HbA1c Target Value of <5.7%
  • 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%
  • Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Baseline through Week 40 ]
    Rate of Documented Symptomatic Hypoglycemic Episodes
  • Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [ Time Frame: Baseline through Week 40 ]
    PK: Steady state AUC of tirzepatide
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) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Official Title  ICMJE A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Brief Summary The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Placebo
    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
  • Placebo Comparator: Placebo
    Placebo administered SC once a week.
    Intervention: Drug: Placebo
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: October 30, 2020) 		478
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019) 		472
Actual Study Completion Date  ICMJE October 28, 2020
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have been diagnosed with type 2 diabetes mellitus (T2DM).
  • Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
  • Have HbA1c between ≥7.0% and ≤9.5%.
  • Be of stable weight (± 5%) for at least 3 months before screening.
  • Have a BMI ≥23 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 an estimated glomerular filtration rate <30 mL/minute/1.73 m².
  • 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 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 India,   Japan,   Mexico,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954834
Other Study ID Numbers  ICMJE 17000
I8F-MC-GPGK ( Other Identifier: Eli Lilly and Company )
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 October 2020

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

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