The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

Sponsors

Lead sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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.

Overall Status Suspended
Start Date June 28, 2019
Completion Date March 16, 2021
Primary Completion Date March 16, 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in Total Clamp Disposition Index (cDI) Baseline, Week 28
Secondary Outcome
Measure Time Frame
Change from Baseline in Fasting Glucose Baseline, Week 28
Change from Baseline in Postmeal Glucose Baseline, Week 28
Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 28
Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) Baseline and Week 28
Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value Baseline, Week 28
Glucagon Concentration at Fasting Baseline and Week 28
Glucagon Concentration at Postmeal Baseline and Week 28
Change from Baseline in Food Intake During Ad Libitum Meal Baseline, Week 28
Enrollment 117
Condition
Intervention

Intervention type: Drug

Intervention name: Tirzepatide

Description: Administered SC

Arm group label: Tirzepatide

Other name: LY3298176

Intervention type: Drug

Intervention name: Semaglutide

Description: Administered SC

Arm group label: Semaglutide

Intervention type: Drug

Intervention name: Placebo

Description: Administered SC

Arm group label: Placebo

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 dipeptidyl peptidase IV (DPP-IV) inhibitors, 3 months prior to study entry

- Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin; or ≥6.5% and ≤9.5% if on metformin in combination with DPP-IV inhibitors

- 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

Gender: All

Minimum age: 20 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Location
facility
Profil Institut für Stoffwechselforschung | Neuss, Nordrhein-Westfalen, 41460, Germany
Profil Mainz GmbH & Co. KG | Mainz, Rheinland-Pfalz, 55116, Germany
Location Countries

Germany

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Tirzepatide

Arm group type: Experimental

Description: Tirzepatide administered subcutaneously (SC)

Arm group label: Semaglutide

Arm group type: Active Comparator

Description: Semaglutide administered SC

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo administered SC

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov