A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Study Details
Study Description
Brief 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 and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 38 weeks, including a 28-week treatment period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tirzepatide Tirzepatide administered subcutaneously (SC) |
Drug: Tirzepatide
Administered SC
Other Names:
|
| Active Comparator: Semaglutide Semaglutide administered SC |
Drug: Semaglutide
Administered SC
|
| Placebo Comparator: Placebo Placebo administered SC |
Drug: Placebo
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Total Clamp Disposition Index (cDI) [Baseline, Week 28]
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study.
Secondary Outcome Measures
- Change from Baseline in Fasting Glucose [Baseline, Week 28]
Measured prior to standardized mixed-meal tolerance tests (sMMTT)
- Change from Baseline in Postmeal Glucose [Baseline, Week 28]
Measured during sMMTT
- Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 28]
Change from Baseline in HbA1c
- Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) [Baseline and Week 28]
ISR0-120 will be determined from C-peptide concentrations using the deconvolution technique
- Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value [Baseline, Week 28]
Hyperinsulinemic euglycemic clamp M-value is calculated from glucose infusion rate (GIR) over the last 30 minutes, corresponding to steady-state (+150 to +180 minutes), corrected for urine loss and space
- Glucagon Concentration at Fasting [Baseline and Week 28]
Measured prior to sMMTT
- Glucagon Concentration at Postmeal [Baseline and Week 28]
Incremental AUC from time zero to 240 minutes after start of the meal [AUC0-240min]) during sMMTT
- Change from Baseline in Food Intake During Ad Libitum Meal [Baseline, Week 28]
Ad libitum meal served buffet-style. Food intake will be recorded during a 45 minute period. The total amount of calories as well as the caloric breakdown (carbohydrates, protein, and fats) will be calculated from the respective nutritional information of the food items.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Profil Institut für Stoffwechselforschung | Neuss | Nordrhein-Westfalen | Germany | 41460 |
| 2 | Profil Mainz GmbH & Co. KG | Mainz | Rheinland-Pfalz | Germany | 55116 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17091
- I8F-MC-GPGT
- 2018-003343-37