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

  • STATUS
    Recruiting
  • End date
    Nov 18, 2022
  • participants needed
    1182
  • sponsor
    Eli Lilly and Company
Updated on 12 September 2021
Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Primary Contact
Sun Coast Clinical Research, Inc (4.7 mi away) Contact
+168 other location
insulin
type 2 diabetes mellitus
metformin
hemoglobin a1c

Summary

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.

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Tirzepatide, Insulin Lispro (U100), Insulin Glargine (U100)
Clinical Study IdentifierNCT04537923
SponsorEli Lilly and Company
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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/m) and 45 kg/m 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 m [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)]
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