Phase 1
N=117
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03951753 ↗Enrolled (actual)
117
Serious AEs
2.6%
Results posted
Mar 2023
Primary outcome: Primary: Change From Baseline in Total Clamp Disposition Index (cDI) — 1.9; 1.1; 0.0 pmol*m-2*L*min-2*kg-1 — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tirzepatide (Drug); Semaglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Clamp Disposition Index (cDI) |
1.9; 1.1; 0.0 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Glucose |
-51.4; -42.4; -4.3 | <0.001 sig |
| SECONDARY Change From Baseline in Postmeal Glucose |
-17414.0; 14236.9; 459.2 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
2.05; -1.64; 0.29 | <0.001 sig |
| SECONDARY Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) |
388.6; 286.6; 7.4 | <0.001 sig |
| SECONDARY Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value |
19.2; 10.7; -0.6 | <0.001 sig |
| SECONDARY Change From Baseline in Glucagon Concentration at Fasting |
-3.6; -2.8; 0.8 | <0.001 sig |
| SECONDARY Change From Baseline in Glucagon Concentration at Postmeal |
-843.6; -502.0; -205.9 | 0.044 sig |
| SECONDARY Change From Baseline in Food Intake During Ad Libitum Meal |
-348.4; -284.1; -38.6 | <0.001 sig |
Summary
This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.
Eligibility Criteria
Inclusion Criteria
- Have T2DM for at least 6 months
- Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
- Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
- Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) >3 months prior to screening
Exclusion Criteria
- Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
- Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
Data sourced from ClinicalTrials.gov (NCT03951753). 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.