Phase 3 N=1,428 Randomized Treatment

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

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT04537923 ↗

Enrolled (actual)

1,428

Serious AEs

9.4%

Results posted

Nov 2023

Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) — -2.26; -1.16 Percentage of HbA1c — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tirzepatide (Drug); Insulin Lispro (U100) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Oct 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)	-2.26; -1.16	<0.001 sig
SECONDARY Change From Baseline in HbA1c	-2.05; -2.27; -2.46; -1.16	<0.001 sig
SECONDARY Percentage of Participants With HbA1c Target Values <7.0%	61.04; 75.64; 79.86; 36.69	<0.0001 sig
SECONDARY Change From Baseline in Body Weight	-6.9; -9.9; -12.0; 3.8	<0.001 sig
SECONDARY Change From Baseline in Fasting Serum Glucose	-33.2; -43.0; -41.6; -10.0	<0.001 sig
SECONDARY Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	-56.7; -61.5; 67.6; -55.8	0.682
SECONDARY Percentage of Participants Who Achieved HbA1c Target Value of <7.0% Without Hypoglycemia	52.70; 70.05; 75.12; 13.41	<0.001 sig
SECONDARY Percentage of Participants Who Achieved Weight Loss ≥5%	64.19; 79.21; 83.15; 6.34	<0.001 sig
SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	1.0; 1.7; 1.7; -0.6	0.005 sig
SECONDARY Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score	0.3; 1.5; 0.7; -1.3	0.020 sig

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.

Eligibility Criteria

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)]

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04537923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.