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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide 		Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Active Comparator
Intensified Conventional Care Dose 		Participants will receive an antihyperglycemic medication
  • Drug: Antihyperglycemic medication
    As prescribed

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.