A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus

Sponsor
Eli Lilly and Company
Study ID
NCT04050553
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Feb 24, 2020
Status verified
Dec 2023
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide
    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.
  • Placebo Comparator: Placebo
    Participants received placebo QW administered SC in one of two study periods.

Primary Outcome Measure

Change in Mean Glucagon Concentration During Induced Hypoglycemia From Target Plasma Glucose (PG) Concentration of 100 Milligrams Per Deciliter (mg/dL) to a Nadir Target of 45 mg/dL [ Time Frame: Week 12 in each study period: Baseline and up to 30 minutes after reaching the nadir glucose level. ]

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