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

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ClinicalTrials.gov Identifier: NCT03987919
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1872 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
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : April 23, 2021

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987919


Contacts
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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

  Show 130 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03987919     History of Changes
Other Study ID Numbers: 17001
I8F-MC-GPGL ( Other Identifier: Eli Lilly and Company )
2018-004422-29 ( EudraCT Number )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
T2DM
GLP-1 RA
Glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs