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A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

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: NCT04093752
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 956 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 Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : February 10, 2022
Estimated Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once weekly.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Active Comparator: Insulin Glargine
Insulin glargine administered SC once daily.
Drug: Insulin Glargine
Administered SC




Primary Outcome Measures :
  1. Mean Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]
    Mean Change from Baseline in HbA1c (10 mg and 15 mg)


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

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

  3. Mean Change from Baseline in HbA1c [ Time Frame: Baseline, Week 40 ]
    Mean Change from Baseline in HbA1c

  4. Percentage of Participants Achieving an HbA1c Target Value of <7.0% [ Time Frame: Week 40 ]
    Percentage of Participants Achieving an HbA1c Target Value of <7.0%

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

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

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

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

  9. 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

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:

  • Type 2 diabetes mellitus
  • Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
  • Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use [≤14 consecutive days] for acute conditions)
  • HbA1c ≥7.5% to ≤11.0% at screening
  • Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
  • Body mass Index (BMI) ≥23 kilograms per meter squared

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Have history of chronic or acute pancreatitis
  • Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
  • Have a history of ketoacidosis or hyperosmolar state/coma
  • Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
  • Have acute myocardial infaction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 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): NCT04093752


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

Locations
Show Show 72 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04093752    
Other Study ID Numbers: 17210
I8F-MC-GPHO ( Other Identifier: Eli Lilly and Company )
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 1, 2020
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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eli Lilly and Company:
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs