A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Hypoglycemia; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04050553

2019-001360-29 (EudraCT Number)

I8F-MC-GPHG (Other Identifier)

17222 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). The study is open to participants with type 2 diabetes. It will last about 42 weeks for each participant.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes mellitus (T2DM) for at least 1 year
• Treated with diet and exercise and stable dose(s) of metformin 3 months prior to study entry with or without 1 additional oral antidiabetic medication (OAM) other than metformin.
• Have a hemoglobin A1c (HbA1c) value at screening of ≥6.5% and ≤9.0 % if on metformin only.
• Have a HbA1c value at screening of ≥6.0% and ≤8.5 %, if on metformin and 1 more allowed OAM.
• Have a body mass index (BMI) between 23 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 (<6 months) ophthalmologic examination
• Impaired renal estimated glomerular filtration rate (eGFR) <60 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 of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (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
• Have had acute myocardial infarction, congestive heart failure New York Heart Association Class III or IV, history of or suspected ischemic heart disease, and/or cerebrovascular accident (stroke [including transient ischemic attack])

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

Participants received a starting dose of 2.5 mg tirzepatide once weekly (QW) for 2 weeks, followed by an increase to 5 mg QW for 2 weeks, and 10 mg QW for 4 weeks until the 15-mg dose was reached and maintained for the remainder of the treatment period (4 weeks) administered subcutaneously (SC) in one of two study periods.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received placebo QW administered SC in one of two study periods.

Treatment:

Drug: Placebo