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A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

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: NCT03861039
Recruitment Status : Active, not recruiting
First Posted : March 4, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : March 2, 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




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Week 52 ]
    Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration


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

  2. Percentage of Participants who Achieve HbA1c <7% [ Time Frame: Week 52 ]
    Percentage of Participants who Achieve HbA1c <7%

  3. Change from Baseline in Fasting Serum Glucose [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Fasting Serum Glucose

  4. Change from Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in average 7-Point SMBG Values

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

  6. Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline [ Time Frame: Week 52 ]
    Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline

  7. Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Fasting Insulin

  8. Change from Baseline in Fasting C-Peptide [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in Fasting C-Peptide

  9. Change from Baseline in Homeostasis Model Assessment B (HOMA-2B) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HOMA-2B

  10. Change from Baseline in HOMA-2S [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in HOMA-2S

  11. Rate of Total Hypoglycemia [ Time Frame: Baseline through Week 52 ]
    Rate of total hypoglycemia

  12. Number of Participants with Anti-Tirzepatide Antibodies [ Time Frame: Baseline through Week 52 ]
    Number of participants with anti-tirzepatide antibodies



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:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participant must:

  • Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
  • Have HbA1c ≥7.0% to <11.0%, as determined by the central laboratory at screening.
  • Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening.
  • Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
  • Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive 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.

Exclusion Criteria:

Participant must not:

  • 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 immediate or urgent 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 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.

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): NCT03861039


Locations
Show Show 34 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: NCT03861039    
Other Study ID Numbers: 17078
I8F-JE-GPGP ( Other Identifier: Eli Lilly and Company )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 15, 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://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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
LY3298176
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists