A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Part of paid clinical trials in Fresno, California.

Sponsor
Eli Lilly and Company
Study ID
NCT04039503
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC as add-on to the pre-trial background medication.
  • Placebo — DRUG
    Administered SC as add-on to the pre-trial background medication.

Study Details

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

Key Dates

Start date
Aug 30, 2019
Status verified
Dec 2021
Primary completion
Dec 22, 2020
Completion
Jan 13, 2021

Study Design

Enrollment
475 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 mg Tirzepatide
    5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once a week.
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once a week.
  • Placebo Comparator: Placebo
    Placebo administered SC once a week.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [ Time Frame: Baseline, Week 40 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Valley Endocrine, FresnoFresnoCalifornia93720-
Sun Coast Clinical Research, IncNew Port RicheyFlorida34652-
Southern New Hampshire Diabetes and EndocrinologyNashuaNew Hampshire03063-
Manhattan Medical ResearchNew YorkNew York10016-
Intend ResearchNormanOklahoma73069-

Find similar trials in Fresno, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Valley Endocrine, Fresno· Fresno, CASun Coast Clinical Research, Inc· New Port Richey, FLSouthern New Hampshire Diabetes and Endocrinology· Nashua, NHManhattan Medical Research· New York, NYIntend Research· Norman, OK

Related Studies