Purpose

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

Eligibility

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

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)]

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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 names:
    • 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 names:
    • LY275585
  • Drug: Insulin Glargine (U100)
    Administered SC

Recruiting Locations

MedStar Health Research Institute
Hyattsville, Maryland 20782
Contact:
3015602987

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study 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

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.