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A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537923
Recruitment Status : Completed
First Posted : September 3, 2020
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Insulin Lispro (U100) Drug: Insulin Glargine (U100) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)
Actual Study Start Date : October 19, 2020
Actual Primary Completion Date : October 11, 2022
Actual Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week with insulin glargine (U100) administered SC.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Drug: Insulin Glargine (U100)
Administered SC
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Drug: Insulin Glargine (U100)
Administered SC
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week with insulin glargine (U100) administered SC.
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Drug: Insulin Glargine (U100)
Administered SC
Active Comparator: Insulin Lispro (U100)
Insulin lispro (U100) administered SC three times a day with insulin glargine (U100) administered SC.
 Drug: Insulin Lispro (U100)
Administered SC
Other Name: LY275585

Drug: Insulin Glargine (U100)
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HbA1c


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HbA1c

  2. Percentage of Participants with HbA1c Target Values <7.0% [ Time Frame: Week 52 ]
    Percentage of Participants with HbA1c Target Values <7.0%

  3. Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Body Weight

  4. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 52 ]
    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 52 ]
    Mean Change from Baseline in Daily Average 7-Point SMBG Values

  6. Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia [ Time Frame: Week 52 ]
    Percentage of Participants who Achieved HbA1c Target Value of <7.0% without Hypoglycemia

  7. Percentage of Participants who Achieved Weight Loss ≥5% [ Time Frame: Week 52 ]
    Percentage of Participants who Achieved Weight Loss ≥5%

  8. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in SF-36 PCS Score

  9. Change from Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in SF-36 MCS Score


Eligibility Criteria
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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 been diagnosed with type 2 diabetes mellitus (T2DM)
  • Have HbA1c between ≥7.5% and ≤11%
  • Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
  • Be of stable weight (± 5%) for at least 90 days
  • Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 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 macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
  • Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
  • 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
  • Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]
Contacts and Locations
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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): NCT04537923


Locations
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04537923    
Other Study ID Numbers: 17204
I8F-MC-GPHD ( Other Identifier: Eli Lilly and Company )
2020-000284-23 ( EudraCT Number )
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 15, 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: https://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:
glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
 Insulin Lispro
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists