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A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05433584
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Antihyperglycemic medication Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : May 9, 2025
Estimated Study Completion Date : June 7, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide
Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Active Comparator: Intensified Conventional Care Dose
Participants will receive an antihyperglycemic medication
Drug: Antihyperglycemic medication
As prescribed




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 104 ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c [ Time Frame: Baseline, Week 208 ]
  2. Change from Baseline in Weight [ Time Frame: Baseline, Week 104 ]
  3. Change from Baseline in Weight [ Time Frame: Baseline, Week 208 ]
  4. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 104 ]
  5. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 208 ]
  6. Change from Baseline in Fasting Serum Glucose (FSG) [ Time Frame: Baseline, Week 104 ]
  7. Change from Baseline in FSG [ Time Frame: Baseline, Week 208 ]
  8. Change from Baseline in Lipids [ Time Frame: Baseline, Week 104 ]
  9. Change from Baseline in Lipids [ Time Frame: Baseline, Week 208 ]
  10. Percentage of Participants Achieving HbA1c <7.0% [ Time Frame: Week 104 ]
  11. Percentage of Participants Achieving HbA1c ≤6.5% [ Time Frame: Week 104 ]
  12. Percentage of Participants Achieving HbA1c <5.7% [ Time Frame: Week 104 ]
  13. Percentage of Participants Achieving HbA1c <7.0% [ Time Frame: Week 208 ]
  14. Percentage of Participants Achieving HbA1c ≤6.5% [ Time Frame: Week 208 ]
  15. Percentage of Participants Achieving HbA1c <5.7% [ Time Frame: Week 208 ]
  16. Change from Baseline in Weight loss of ≥5%, [ Time Frame: Baseline, Week 104 ]
  17. Change from Baseline in Weight loss of ≥10% [ Time Frame: Baseline, Week 104 ]
  18. Change from Baseline in Weight loss of ≥15% [ Time Frame: Baseline, Week 104 ]
  19. Change from Baseline in Weight loss of ≥5% [ Time Frame: Baseline, Week 208 ]
  20. Change from Baseline in Weight loss of ≥10% [ Time Frame: Baseline, Week 208 ]
  21. Change from Baseline in Weight loss of ≥15% [ Time Frame: Baseline, Week 208 ]
  22. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [ Time Frame: Week 104 ]
    A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as blood glucose (BG) <54 milligram/deciliter (mg/dL) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia

  23. A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia [ Time Frame: Week 208 ]
    A composite endpoint defined as HbA1c ≤ 6.5%, weight loss ≥10%, no hypoglycemia, defined as BG <54 mg/dL (<3.0 mmol/L) and/or severe hypoglycemia

  24. Change from Baseline in β-cell Glucose Sensitivity [ Time Frame: Baseline, Week 104 ]
    β-cell Glucose Sensitivity assessed by Oral Glucose Tolerance Test (OGTT)

  25. Change from Baseline in β-cell glucose sensitivity [ Time Frame: Baseline, Week 208 ]
    Change from baseline in β-cell glucose sensitivity assessed by OGTT

  26. Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration [ Time Frame: Baseline, Week 104 ]
    Insulin Secretion Rate assessed by OGTT

  27. Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration [ Time Frame: Baseline, Week 208 ]
    Insulin Secretion Rate assessed by OGTT

  28. Change from Baseline in Postprandial Insulin Sensitivity Indices [ Time Frame: Baseline, Week 104 ]
    Postprandial Insulin Sensitivity Indices assessed by OGTT

  29. Change from Baseline in Postprandial Insulin Sensitivity Indices [ Time Frame: Baseline, Week 208 ]
    Postprandial Insulin Sensitivity Indices assessed by OGTT

  30. Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] [ Time Frame: Baseline through Week 104 ]
    Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT

  31. Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)] [ Time Frame: Baseline through Week 208 ]
    Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)] assessed by OGTT

  32. Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain [ Time Frame: Baseline, Week 104 ]
  33. Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain [ Time Frame: Baseline, Week 208 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
  • Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
  • Have been on a stable treatment of metformin only at least 90 days preceding baseline

    • with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
    • <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have a history of chronic or acute pancreatitis any time prior to study entry
  • Have a history of

    • proliferative diabetic retinopathy
    • diabetic macular edema, or
    • no proliferative diabetic retinopathy requiring immediate or urgent treatment
  • Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry

    • myocardial infarction
    • percutaneous coronary revascularization procedure
    • carotid stenting or surgical revascularization
    • nontraumatic amputation
    • peripheral vascular procedure (e.g., stenting or surgical revascularization)
    • cerebrovascular accident (stroke), or congestive heart failure
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
  • Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
  • Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.

    • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

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): NCT05433584


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CT LILLY (1-877-285-4559) or : 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 97 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: NCT05433584    
Other Study ID Numbers: 17205
I8F-MC-GPHE ( Other Identifier: Eli Lilly and Company )
2022-000130-42 ( EudraCT Number )
2022-5010733-40-00 ( Other Identifier: EU Trial Number )
U1111-1282-0263 ( Registry Identifier: World Health Organization )
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
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://vivli.org/

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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:
T2D
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists