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

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

  • Type 2 Diabetes

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.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
10 mg Tirzepatide 		10 mg tirzepatide administered SC once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
15 mg Tirzepatide 		15 mg tirzepatide administered SC once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Active Comparator
Insulin Lispro 		Insulin lispro 100 units per milliliter (U100) administered SC three times a day.
  • Drug: Insulin Lispro (U100)
    Administered SC
    Other names:
    • LY275585

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact